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. 2021 Jul 1;99(7):682–692.

Deficiency, incapacity and social disadvantage of patients with chronic hepatitis B: a case-control study

Déficience, incapacité et désavantage social des patients atteints d’hépatite B chronique : une étude cas-témoins

Jihene Bergaoui 1, Imed Latiri 1,2, Helmi Ben Saad 1,2,3,✉
PMCID: PMC8796680  PMID: 35260999

Summary

Introduction. Studies examining impairment, disability and social disadvantage of patients with chronic viral hepatitis B (CHB) are scarce and present conflicting conclusions.

Objective. To assess the deficiency, incapacity and social disadvantage of patients with CHB.

Methods. This is a project of a case-control study with two age-matched groups. Cases (n=27) will be untreated patients with a CHB. Controls (n=27) will be healthy participants. The following data will be collected: deficiency [anthropometric, biochemical (renal and hepatic functions, lipid balance, and inflammatory markers), haematological, virological, handgrip-strength, and spirometric data], incapacity [6-min walk distance, number of stops, oxy-haemoglobin saturation, dyspnoea (visual analogue scale), heart-rate, and blood-pressure] and social disadvantage [“chronic liver disease” and physical-activity questionnaires]. Each spirometric data < lower-limit-of-normal will be considered abnormal. A handgrip-strength <26 kg (male) or <16 kg (female) will be considered low. The signs of walking intolerance will be: stop during the walk, 6-min walk distance ≤ lower-limit-of-normal, dyspnoea at the end of the walk> 5/10, drop in oxy-haemoglobin saturation >5 points, heart-rate at the end of the walk ≤60%. A total physical-activity score <9.42 will classify the participant as sedentary.

Expected results. Compared with controls, cases will have a marked alteration of submaximal aerobic data. These alterations will worsen quality-of-life and may be related to muscle and/or spirometric abnormalities, and supported by systemic inflammation and high viral load.

Keywords: Virology, liver, handgrip strength, spirometry, field test, quality of life

INTRODUCTION

In addition to the hepatic manifestations such as cirrhosis or hepatocellular carcinoma, chronic-hepatitis B (CHB) causes extrahepatic manifestations such as cardiovascular and pulmonary ones 1, 2, 3, 4, 5, 6, 7, which significantly aggravate the morbidity and mortality associated with CHB 8. According to the International Classification of Functioning, Disability and Disadvantage, the three stages of development (ie, deficiency, incapacity, and social disadvantage) of each chronic pathology should be systematically evaluated 9.

Many studies, which explored CHB-related deficiency, showed the extrahepatic deleterious effects of CHB on the functional state of the body at various levels [eg; loss of skeletal muscle mass, weakness of respiratory muscles, myocardial injury 2, 3, 4, 5, 6, 7, 8, 9 . Studies that analysed spirometric data/profile of patients with CHB are rare and report conflicting data 10, 11. First Teuber et al. 11 showed that patients with CHB (n=25) had normal forced-expiratory-volume-in-one-second (FEV1), forced-vital-capacity (FVC), and FEV1/FVC. Likewise, no correlation with inflammatory activity or extent of fibrosis was found 11. Second, Goh et al. 10 investigated the associations of viral hepatitis B with FEV1, FVC, and FEV1/FVC using multiple linear regression models adjusted for confounding factors like age, height, sex, race/ethnicity, smoking status/duration. The authors reported that patients with CHB (n=35) had significantly higher FEV1, FVC and FEV1/FVC 10. In practice, the handgrip strength (HS) is an indicator of an overall muscle strength, nutritional status, muscle mass, and 6-min-walk-distance (6MWD), and is a predictor of mortality, disability and surgical complications 12, 13, 14. In chronic liver diseases, measuring HS has several advantages: it assesses the nutritional status and the risk of falling, it is correlated with the muscle mass, and it is an indicator of walking speed 15, 16, 17, 18. Moreover, a low HS is associated with non-alcoholic fatty liver disease independently of other data like socio-demographic characteristics, weight, metabolic syndrome, concomitant diseases, and lifestyle 19.

Studies which explored the incapacity related to CHB are rare 2, 3, 20, 21. It appears that only four studies have explored maximal and/or submaximal aerobic capacities of adults with CHB 2, 3, 20, 21 Table 1. The authors of the first study investigated the submaximal aerobic capacity, and reported that compared to healthy participants (n=45), patients with a CHB (n=49) had a significantly lower 6MWD by 31 m 20. The authors of the second study investigated the maximal aerobic capacity of 26 cirrhotic patients (two of whom had a post-CHB cirrhosis) 21. They reported a positive correlation-coefficient of 0.64 between the peak oxygen uptake () and the maximum-inspiratory-pressure (MIP), and the low quality-of-life (QOL) scores. The third study aimed to compare the strength of the respiratory muscles (MIP and maximal-expiratory-cirrhosishad better MIP and MEP, and had a significantly higher 6MWD by 91 m 2 . Regarding QOL, out of the eight dimensions of the SF-36 questionnaire, only the “functional capacity” and the “limitation by the physical aspect” were significantly higher in the group with post-CHB cirrhosis compared to the one with alcoholic cirrhosis 2 . The authors of the fourth study investigated both the submaximal and the maximal aerobic capacities 3 .They aimed to test the relationship between 6MWD, MIP, VO2peak and the survival rate of patients with different aetiologies of cirrhosis [post-CHB (n=16), postchronic hepatitis C (n=40), alcoholic (n=30)] 3 . They concluded that MIP, 6MWD and VO2peak are predictors of mortality in patients with cirrhosis 3 .

Table 1. Studies analysing the aerobic fitness of patients with chronic hepatitis B: methodology and results.

1 st author (ref)

Alameri 20

Galant 21

Galant 2

Faustini Pereira 3

Study duration

.12 months

.5 months

.5 months

.3 years

City (Country)

.Riyad (Saudi Arabia)

.Porto Alegre (Brazil)

.Porto Alegre (Brazil)

.Porto Alegre (Brazil)

Main aims

.To compare the 6MWD of healthy participants and patients with hepatic pathologies .To study the correlations between the 6MWD and certain clinical and biochemical markers of the disease

.To assess the correlation between O2peak, and respiratory muscle strength and QOL in patients with hepatic cirrhosis

.To compare the muscle strength, exercise capacity and QOL data of 3 groups of patients with cirrhosis

.To evaluate the relationship between the 6MWD, MIP, O2peak and the survival rate of patients with cirrhosis

Study design

.Prospective study

.Cross-sectional study

.Cross-sectional study

.Prospective study

Sample (M/F)

.250 (150/100)

.26 (14/12)

.86 (64/22)

.86 (66/20)

Populations

4 groups .GA: 45 (22 M) healthy .GB: 49 (22 M) CHB .GC: 58 (42 M) CHC .GD: 98 (64 M) cirrhosis

3 groups (cirrhosis) .GA: 2 post-CHB .GB: 16 post-CHC .GC: 8 post-alcohol

3 groups (cirrhosis) .GA: 40 (30 M) post-CHC .GB: 14 (10 M) post-CHB .GC: 32 (20 M) post-alcohol

3 groups (cirrhosis) .GA: 40 post-CHC .GB: 16 post-CHB .GC: 30 post-alcohol

Characteristics of patients with CHB

.Ag HBs+ .ALT: normal or increased .Bilirubin, albumin, INR: normal .CBC: normal .Abdominal echography: normal .No PH or cirrhosis

.NR

.NR

.No systemic disease .No co-infection .No chronic disease

Age (years)

GB: 18-80 a , 38±12 b

.TS: 53±9 b

GB: 52±6 b

.< 65, TS: 56±8 b

Height (m)

.NR

.NR

GB: 1.69±0.73 b

.TS: 1.67±0.83 b

Weight (kg)

.NR

.NR

GB: 69±11 b

.TS: 67±9 b

BMI (kg/m 2 )

.GB: 33.3±20.6 c

.TS: 25.4±2.25 c

.TS: 24.10±1.21 b

Applied tests (main collected data)

Deficiency

.NA

.Respiratory muscle strength: MIP/MEP (cmH2O)

.Spirometric data: FEV1, FVC .Respiratory muscle strength: MIP/MEP (cmH2O)

.Respiratory muscle strength: MIP/MEP (cmH2O)

Incapacity

.6MWT: 6MWD (m), HR (bpm), oxy-sat (%), dyspnoea (Borg scale)

.CPET: O2peak (mL/min/kg), dyspnoea (Borg scale)

.6MWT: 6MWD (m), HR (bpm), oxy-sat (%), RR (cpm), dyspnoea (Borg scale)

.6MWT: 6MWD (m), oxy-sat (%), HR (bpm) .CPET: O2peak (mL/min/kg)

Social disadvantage

.NA

.QOL: SF-36

.QOL: SF-36

.NA

Other data

.Biological data (ALT, AST, GGT, AP, haemoglobin, albumin, bilirubin, creatinine)

.MELD: disease severity score

.MELD: disease severity score

.Survival rate

Main results

Deficiency

.NA

.MIP: 73±22b .MEP:79±29b

.MIP: GA: 82±14b, GB: 72±7b, GC: 66±11b .MEP: GA: 83±12b, GB: 82±14b, GC: 65±11b .FEV1 (%): GA: 91±17b, GB: 89±18b, GC: 87±14b .FVC (%): .GA: 95±19b, GB: 97±17b, GC: 93±30b

.MIP: =70±14c, < 70: SRof 62%, � 70: SRof 93%, AUC ROC, sensibility and specificity: 0.69/71%/53%, SR 18% more higher with MIP increase

Incapacity

.6MWD: GA: 421±47b, GB: 390±53b, GC: 357±72b GD: 306±111b .HRend (bpm): GB: 86±13b .Oxy-satend (%): GB: 98.2±0.76b .Dyspnoeaend:GB: 0.53±0.73b

.O2peak: 17.01±5.91 b

.6MWD: GA: 476±29b, GB: 464±32b, GC: 373±50b .HRrest (bpm): GB: 77±11b .HRend (bpm): GB: 91±15b .RRrest (cpm): GB: 15±3b .RRend (cpm): GB: 21±3b .Oxy-satrest (%): GB: 98±1b .Oxy-satend (%): GB: 97±1b .Dyspnoearest: GB: 1±0,6b .Dyspnoeaend: GB: 2±1b

.6MWD: 410±29b, < 410: SRof 55%, � 410: SRof 97%, AUCROC, sensibility and specificity: 0.87/92%/31%, SR 20% more higher with 6MWD increase .O2peak: =17.06c, < 17: SRof 55%, �17: SRof 94%, AUCROC, sensibility and specificity: 0.78/87%/41%, SR 30% more higher with O2pic increase

Social disadvantage

.NA

.SF-1=47±26 b , SF-2=35±38 b , SF-3=49±24 b , SF-4=42±18 b , SF-5=48±28 b , SF-6=61±31 b , SF-7=51±42 b , SF-8=58±30 b

.SF-1=65±22 b , SF-2=65±21 b , SF-3=61±26 b , SF-4=52±18 b , SF-5=63±26 b SF-6=71±25 b , SF-7=52±15 b , SF-8=68±16 b

.NA

Other results

6MWD correlated with .Age (r=-0.482) .Height (r=0.281) .Dyspnoea [rest (r=-0.518), end (-0.581)] .Haemoglobin (r=0.373) .Albumin (r=0.311)

O2peakcorrelated with: .MIP (r=0.64) .MELD (r=0.91)

6MWD correlated with: .MELD (r=-0.56)

Mortality .GA: 3 .GB: 5 .GC: 11

Conclusion

.The 6MWT is useful for assessing the physical capacity of patients with chronic liver disease.

.There is a correlation between theO2peak and MIP. .Patients have poor QOL

.Compared to patients with cirrhosis post-alcoholic, those with cirrhosis post-CHB have better respiratory muscle strength, better exercise capacity, and better QOL.

.6MWD, MIP, O2peak: predictors of mortality in patients with cirrhosis

ALT: alanine-aminotransferase. AP: alkaline-phosphatase. AST: aspartate-aminotransferase. AUC: Area-under-the-curve. CBC: chronic-hepatitis B. CBC: complete-blood-count. CHC: chronic-hepatitis c. CPET: cardiopulmonary-exercise-test. end : end of the 6MWT. F: female. FEV 1 : forced expiratory-volume-in-one-second. FVC: forced-vital-capacity. G: group. GGT: gamma-glutamyltranspeptidase.HR: heart-rate. INR: international-normalized-ratio. M: male. MELD: disease-severity-score. MEP: maximal-expiratory-pressure. MIP: maximal-inspiratory-pressure. NA: non-applied. NR: non-reported. Oxy-sat: oxygen haemoglobin saturation. PH: portal-hypertension. QOL: quality-of-life. r: coefficient of correlation. rest : at rest before the 6MWT. ROC: receiver-operating-characteristic. RR: respiratory-rate. SF-1: functional-capacity.SF-2: limited by the physical aspect. SF-3: pain. SF-36: short form-36. SF-4: general health. SF-5: vitality.SF-6: social. SF-7: mental health. SF-8: limitation by emotional aspects. SR: survival rate. TS: total-sample. O2peak: peak of oxygen consumption. 6MWD: 6-min-walk-distance.6MWT: 6-min-walk-test. Date were expressed: a Minimum-maximum; b Mean±standar-deviation, c Mean. Study of Alameri: GB: younger than GC or GD 6MWD of GB: lower than this of GA, higher than these of GC and GD Study of Galant-2012: FEV 1 and FVC of GB: similar to other 2 groups MIP and MEP of GB: higher than these of GC. 6MWD of GB: higher than this of GC. HR end of GB: lower than this of GC. Dyspnoea end of GB: lower than this of GC. SF-1 and SF-2 scores of GB: higher than these of GC.

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In the studies where the 6-min-walk-test (6MWT) was performed 2, 3, 20, the 6MWD was expressed in absolute value. This expression mode could be a source of confusion, since it was more logical to standardize the 6MWD according to the sex and anthropometric data, which would allow a better comparison between the different groups 22 .

Health-related QOL and behaviours (eg, physical-activity) are important for the management of chronic medical conditions 23. Regarding social disadvantage, many studies explored the QOL of patients with CHB at different stages of the disease 24, 25. Despite the diversification of the used questionnaires, the majority of studies confirmed the deterioration of QOL of patients with CHB. However, the use of a generic QOL questionnaire [eg, SF-36 24 applied in some studies 2, 21 is open to criticism, since there are specific QOL questionnaires to liver diseases, including the "chronic liver disease questionnaire" (CLDQ) 26, which was validated in patients with CHB 27. It seems that 50% of patients with CHB are physically-inactive 28 . Physical-activity is among the most critical behavioural determinants of health 29. From a public health standpoint, it is vital to determine the level of physical-activity in order to provide a theoretical basis for the expansion of suitable guidelines to turn aside the problems related to physical-inactivity 30. Therefore, studies raising the impacts of CHB on physical-activity are interesting 28. However, such studies are scarce 28, and often applied a non-specific questionnaire 31. For example, in a Korean study 28, physical-inactivity was defined as the performance of a moderate-to-vigorous physical-activity <150 min/week 31. It was more reasonable to use a specific questionnaire like the Voorrips questionnaire 32 which allows the calculation of scores related to three types of physical-activity: daily, sports, and leisure activities.

To the best of the authors' knowledge, no study has simultaneously explored the aforementioned three stages of development in a single and homogeneous group of patients with non-cirrhotic CHB. In addition, the four studies analysing the maximal and/or submaximal aerobic capacities of patients with CHB 2, 3, 20, 21 had a major methodological limitations related to the studied populations. Indeed, only one study included patients with non-cirrhotic CHB 20 , and the other three studies included cirrhotic patients of different aetiologies including post-CHB 2, 3, 21. This approach could be a source of confusion, since the clinical outcomes are different. Taking into account the aforementioned points, there are two objectives for this case-control study (case: patients with non-cirrhotic CHB; control: healthy participants). The main objective is to compare data of the two groups while respecting the three evolutionary stages of any chronic disease: i) Deficiency: anthropometric, biochemical, haematological, spirometric, and HS data; ii) Incapacity: 6MWT data; and iii) Social disadvantage: CLDQ and physical-activity questionnaires data. The second objective is to assess, in patients with CHB, the correlations between 6MWD, and biological, spirometric, HS, QOL and physical-activity data.

POPULATION AND METHODS Study design

This work is a protocol of a case-control study that will be carried out in collaboration with four departments (ie, physiology and functional explorations, infectious diseases, biochemistry and haematology laboratories (Farhat HACHED hospital, Sousse, Tunisia)). The approval of the hospital medical and research ethics committee (approval N° 3010/2020) was obtained. All participants will receive a report of their explorations.

Study population and protocol

Two groups of participants will be included. Cases will be patients with a CHB and controls will be healthy participants. The recruitment methods, the inclusion and non-inclusion criteria are detailed in the Box 1. The study consists of a single visit where a maximum of three participants will be explored in the morning between 8 a.m. and noon. Figure 1 details the study protocol. When welcoming participants, an information sheet will be issued and an informed consent will be signed.

Box 1. Chronic-hepatitis B (CHB) diagnosis, and applied inclusion, non-inclusion and exclusion criteria.

Cases

Controls

CHB diagnosis

.Viral activity: assessed through a DNA-hepatitis B virus test. .Analysis: COBAS® TaqMan® HIV-1 analyser. .Virological exam: done 3 to 4 months before the patient inclusion in the study in order to determine the viral load 33.

-

Recruitment method

.Patients followed at the outpatient clinic infectious diseases

.Caregivers of patients with a chronic-hepatitis B .Relatives of persons involved in the study .An advertisement to recruit healthy participants will be launched via the personal Facebook account of the 1st author

Inclusion criteria

.Age: 30 to 50 years .Chronic-hepatitis B (CHB) diagnosed with a surface antigen persisting for at least 6 months before inclusion in the study .AgHBe positive or negative with a viral load > 2000 IU/ml 33 .No comorbidities .No co-infection with other viruses .No liver damage .No indication of treatment [fibroscan score 0-6, and/or score at the liver biopsy puncture (activity and fibrosis) <2] .No physical/mechanical problem

.Age: 30 to 50 years .Healthy participant .No chronic diseases .No physical/mechanical problem .No alcohol intake

Non-inclusion criteria

.6-min-walk-test contraindications 32: signs of unstable angina or myocardial infarction during the previous month, resting heart-rate≥ 120 bpm, systolic-blood-pressure≥ 180 mmHg, diastolic-blood-pressure≥ 100 mmHg .History of orthopaedics/rheumatologic conditions which may interfere with the walking or handgrip-strength .Systemic impairment which may influence blood test results (eg; diabetes-mellitus or renal-failure)

Exclusion criteria

.Loss of certain biological data .Incomplete performance of the 6-min-walk-test and/or spirometric test
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Figure 1. Study protocol.

Figure 1. Study protocol.

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Sample size

The sample size was estimated using this formula 35 : N = ((r+1) (Zα/2 + Z1-β)2 s2)/(rd2).

•   “Z α/2 ” is the normal deviate at a level of significance = 1.96 (5% level of significance);

•   “Z 1-β ” is the normal deviate at 1-β% power with β% of type II error (1.28 at 90% statistical power);

•   “r” (= n1/n2,n1 and n2 are the sample sizes for the cases and controls groups, such N = n1 + n2) is the ratio of sample size required for two groups (r = 1 gives the sample size distribution as 1:1 for two groups);

•   “s” and “d” are the pooled standard-deviation (SD) and difference of 6MWD means of two groups. These two values were obtained from a previous case-control study aiming to compare the 6MWD of 48 patients with CHB with that of 45 healthy participants 20. Controls and cases had 6MWD means of 421 and 390 m, respectively, with a mean SD of 50 m.

The injection of the aforementioned data into the formula results in a total sample of 54 participants (27 in each group). The assumption of 10% loss of some biological data gives a revised sample of 60 participants (=54/(1-0.10)).

CHB diagnosis

The CHB diagnosis criteria 33 are detailed in Box 1 .

Data collection procedures, and applied definitions

Clinical, sociodemographic and socioeconomic data will be collected using a standard medical questionnaire, which is widely used in hospital departments (Appendix/Section A). The questions, which will be asked in Arabic, are essentially closed-ended and most often dichotomous questions. The socioeconomic-level will be determined according to the participant profession 36 and two levels will be defined (unfavourable/favourable). Two schooling-levels will be defined arbitrarily [low (illiterate/primary school); high (secondary/university)]. Cigarettes smoking will be evaluated in pack-years and participants will be classified into two groups (non-smoker: <5 pack-years; smoker: >=5 pack-years). Depending on alcoholic habit, participants will be classified into two groups (consumer/non-consumer).

Sex and age (years) will be noted, and height (cm) will be measured. Body composition [weight (kg), body mass index (BMI, kg/m2), muscle mass rate (%), body fat rate (%), water percentage (%), bone mass (kg)] will be measured and/or calculated using a bioelectric impedancemeter [Beurer (BF-600, Beurer GmbH, Germany)]. According to the BMI, four corpulence statuses will be identified: leanness (BMI <18.5 kg/m2), normal weight (BMI: 18.5-24.0 kg/m2), overweight (BMI: 25.0-29.9 kg/m2), and obesity (BMI ≥30 kg/m2).

Blood samples will be taken on serum tubes from peripheral venous blood and will be sent to the biochemistry and haematology laboratories. The blood will be collected using a 20-ml syringe and will be divided into four tubes [ethylene-diamine-tetra-acetic, citrat, fluoride; lithium heparin, and dry tubes]. The usual techniques of the two laboratories will be used to determine the values of each biological data. The haematological and biochemical data that will be determined/calculated and the definitions that will be applied 5 ,37, 38, 39 , 40 are detailed in Boxes 2 and 3, respectively.

Box 2. Haematological data, erythrocyte-sedimentation-rate (ESR) and applied definitions.

Tubes

Data

Normal values

Applied definitions

Ref

EDTA

Haemoglobin

M: 14-17 g/dL F: 12-16 g/dL

Anaemia: haemoglobin < 12 (F) or< 14 (M) Polycythaemia: haemoglobin > 17

5

Erythrocytes

4.2-5.9 106/mm3

Low: erythrocytes < 4200000

40

Leucocytes

4.5-11 103/mm3

Leukopenia: leucocytes < 4500 Leucocytosis: leucocytes > 11000

40

Neutrophils

2.6-8.5 103/mm3

High: neutrophils > 8500

40

Eosinophils

0-0.55 103/mm3

High: eosinophils > 550

40

Basophils

0-0.22 103/mm3

Basocythemia: basophils> 220

40

Lymphocytes

0.77-4.5 103/mm3

Lymphopenia: lymphocytes < 770

40

Monocytes

0.14-1.3 103/mm3

Monocytosis: monocytes > 1300

40

Thrombocytes

150-350 103/mm3

Thrombocytopenia: thrombocytes < 150000 Thrombocytosis: thrombocytes > 350000

40

ESR- 1st hour

M: 0-15 mm F: 0-20 mm

Biological inflammatory syndrome: ESR> 15 (M) or > 20 (F)

40

Citrate

Prothrombin-level

70-100%

Low: prothrombin-level < 70%

37

EDTA: ethylene-diamine-tetra-acetic. F: female. M: male.

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Box 3. Biochemical data, C reactive protein (CRP), and applied definitions.

Tubes

Function

Data

Normal values

Applied definitions

Ref

Fluoride

Renal function

Urea

0.15-0.50 g/L

High: urea> 0.50

38

Creatinine

7-13 mg/L

High: creatinine > 14

38

Lithium heparin

Liver function

AP

36-150 UI/L

High: AP> 460

40

ALT

0-35 UI/L

Cytolysis: ALT > 35

40

AST

0-35 UI/L

Cytolysis: AST > 35

40

Total-bilirubin

0.3-1.2 mg/dL

High: bilirubin > 1.2

40

Conjugated-bilirubin

0-0.3 mg/dL

High: bilirubin > 0.3

40

GGT

8-78 UI/L

High: GGT > 78

40

Dry tube

Albumin

35-54 g/L

Low: albumin < 35

40

Lipid panel

TC

3.88-5.15 mmol/L

High: TC > 5.15

40

TG

< 2.82 mmol/L

High: TG > 2.82

40

HDL-C

≥ 1.04 mmol/L

Low: HDL-C < 1.04

40

LDL-C (=TC-HDL-C - TG/5)

≤ 3.36 mmol/L

High: LDL-C > 3.36

40, 41

Lithium heparin

Others

UA

0.15-0.47 mmol/L

High: UA> 0.47

40

CRP

< 5 mg/L

Biological inflammatory syndrome: CRP>12

39

CPK

30-170 U/L

Myolysis: CPK > 170

40

Fluoride

Fasting-glycaemia

3.9-5.8 mmol/L

High: glycaemia> 5.8 Low: glycaemia< 3.9

40

ALT: alanine-aminotransferase. AP: alkaline-phosphatase. AST: aspartate-aminotransferase. CPK: creatine-phosphokinase. GGT: gamma-glutamyl-transpeptidase. HDL-C: high-density-lipoprotein-cholesterol. LDL-C: low-density-lipoprotein-cholesterol. TC: total-cholesterol. TG: triglycerides. UA: uric-acid.

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The upper-limb muscle strength will be measured using an adjustable handle digital HS dynamometer (TKK5401®, Takei Scientific Instruments Co., Ltd., Niigata, Japan). This reliable and valid dynamometer has a measuring range of 5 to 100 kg of force, with increments of 1 kgf 42 . Participants will have a brief demonstration and verbal instructions for the test, and if necessary, the dynamometer will be adjusted to the size of the hand. The measurement will be taken in a standing position with the shoulder adducted and in neutral rotation, and the arms parallel but not in contact with the body. Participants will be asked to tighten the dynamometer as hard as possible, while exhaling. The test will be repeated three times for each hand. The highest values obtained will be used for the evaluation of the maximum-voluntary strength. The HS will be expressed as an absolute value (kg) and any value <26 kg (male) or <16 kg (female) will be considered low 43.

Spirometry will be performed using a portable spirometer (SpirobankG MIR via del Maggiolino 12500155 Rome, Italy) according to the international recommendations 44. The following data will be noted: FEV1 (L, %), FVC (L, %), FEV1/FVC (absolute value), maximal mid-expiratory-flow (L/s, %). Local spirometric norms will be used 45 and any spirometric data< lower-limit-of-normal (LLN) will be considered low 46. The obstructive-ventilatory-defect will be defined as FEV1/FVC <LLN 46.

The submaximal aerobic capacity will be evaluated via the 6MWT. Participants will be asked to wear comfortable clothing and appropriate footwear for walking, to come on an empty stomach, and finally not to perform strenuous exercise in the two-hours preceding the 6MWT 34. A single 6MWT will be performed in a 40 m flat corridor. The instructions given before the 6MWT will correspond to those recommended by the international guidelines 34. Walking will be stopped if the participant experiences chest pain, intolerable dyspnoea, leg cramps, staggering, diaphoresis, and a pale or ashen appearance 34. Heart-rate (bpm), oxy-haemoglobin saturation (Oxy-sat, Handheld pulse oximeter M700, Biolight CO., LTD. China), blood-pressure and dyspnoea, will be measured and/or assessed for a participant sitting in a chair before (rest) and immediately at the end (end) of the 6MWT. The maximal predicted heart-rate will be calculated [= 208 - 0.7 × Age] 47. The following 6MWT data will be noted, measured or calculated: 6MWD (m, %), number of stops while walking, heart-rate (bpm, %), Oxy-sat (%) and ∆Oxy-sat (=Oxy-satend - Oxy-satrest), dyspnoea and blood-pressure. Dyspnoea will be assessed via the visual-analogue-scale rated from 0 (no shortness of breath) to 10 (maximum shortness of breath) 48. North-African 6MWD norms will be used and 6MWD LLN will be calculated 22, 49 . The following definitions will be applied 22, 36, 46:

• Signs of walking intolerance: 6MWD<LLN, stop while walking, dyspnoeaend> 5/10;

• Clinically significant desaturation: ∆Oxy-sat> 5 points

• Chronotropic insufficiency: heart-rateend<60%

The CLDQ is a specific questionnaire 26 validated in patients with a CHB 27. This short and easy-to-administer questionnaire correlates with the severity of the disease 26. The CLDQ, which is intended to find out how the patients felt during the last two weeks, includes 29 questions with the choice of only one answer among seven (1: all the time; 2: most of the time; 3: a good bit of the time; 4: some of the time; 5: a little of the time; 6: hardly any of the time; 7: None of the time). The questions are divided into six areas: Abdominal Symptoms (questions 1, 5, 17); Fatigue (questions 2, 4, 8, 11, 13); Systemic Symptoms (questions 3, 6, 21, 23, 27); Activity (questions 7, 9, 14); Emotional Function (questions 10, 12, 15, 16, 19, 20, 24, 26); and Worry (questions 18, 22, 25, 28, 29). The overall CLDQ score, which is calculated by adding all the answers chosen, can range from 0 to 203. A high score corresponds to a poor QOL 26. The CLDQ was translated into Tunisian dialect by the research team (Appendix/Section B). To ensure a good translation, a role-play between the principal investigators was performed.

The level of physical-activity will be estimated by the Voorrips questionnaire 32. This questionnaire is reproducible and its score is positively correlated with the 24-hour measurement of the physical-activity quantified by the use of a pedometer 32. The Arabic version (Appendix/Section C) is invalidated but widely used in previous studies 50. This questionnaire includes 51 questions divided into three parts, each evaluating a different score for three types of physical-activity: daily, sports and leisure activities. The sum of the three scores represents the total-physical-activity score. According to this last score, two groups of participants will be defined: [sedentary (score <9.42); active (score ≥ 9.42)] 32.

Statistical analysis

The analysis of the distribution of quantitative data will be performed using the Kolmogorov-Smirnov test. When the distribution will be normal and the variances will be equal, the results will be expressed by their means±SD. Otherwise, the results will be expressed by their medians (interquartiles). Categorical data will be expressed as numbers (%). Student's T and/or Mann-Whitney U tests will be used to compare quantitative data from the two groups. The Chi-square test will be used to compare the percentages of participants between the two groups. Student's T test will be used to analyse the associations between the measured 6MWD (m) and the patients’ categorical data. The correlation-coefficient will be used to analyse the associations between the 6MWD and the quantitative data of the deficiency (biological, spirometric and HS data) or the scores of QOL and physical-activity. To assess the 6MWD influencing factors, the authors intend to establish a linear multiple regression. Only the significantly associated independent data, in the previous step, will be included in this regression. All statistical procedures will be performed using a Statistica statistical software (StatSoft, Inc. (2011). STATISTICA, version 12). Significance will be set at the 0.05 level.

EXPECTED RESULTS

CHB is believed to “alter” spirometric data, HS, submaximal aerobic capacity and QOL. In this context, in front of patients newly diagnosed with CHB, it will be desirable to systematically explore the three stages of the chronic evolution of their disease, namely deficiency (HS and spirometry), incapacity (6MWT) and social disadvantage (questionnaires of QOL and/or physical-activity) and seek the impact of the incapacity on the QOL. The final outcome expected from the results of this protocol is twofold: i) integrate HS, spirometry and 6MWT as means of evaluating the progress report of patients with CHB in order to assess the independence level of the patient during the daily living activities; and ii) put forward physiopathological arguments reinforcing the role of cardio-respiratory rehabilitation in the therapeutic management of CHB.

Appendix 1. MEDICAL QUESTIONNAIRE.

SECTION A. GENERAL QUESTIONNAIRE (IN FRENCH)

Identification

1 Nom:…… 2 Prénom:……… 3 Date de naissance:… /…… /…………4 Origine: …………………

5. Niveau de scolarisation: 1. Analphabète 2. Ecole primaire 3. Ecole secondaire 4. Universitaire 5. Autres

6. Statut professionnel: 1 En exercice 2 Retraité

7. Profession actuelle ou antérieure: 1. Artisan 2. Commerçant 3. Cadre et profession intellectuelle supérieure 4. Profession intermédiaire 5. Ouvrier 6. Agriculteur exploitant 7. Sans activités 8. Autres

Caractéristiques de l’hépatite virale B (pour les malades uniquement)

8. Date de découverte (année :……… 9 Traitements: 0 Non traité…… 1 Traité:………………

10. Coïnfection virale: 0 Non 1 Oui ………11 Charge virale:…………u/ml

12.Fibrosanner: 0 Non 1 Oui………13 Si oui à la question 12: score:…………………

14. PBF: 0 Non 1 Oui …… 15 Si oui à la question 14: score:……

Antécédents personnels

16. Maladie respiratoire: 0 Non 1 Oui; Si oui passer aux questions 17 et 18

17. Signes/symptômes/pathologie: 1. Toux > 3 mois par an 2. Toux productive > 3 mois par an 4. Tuberculose 8. Fibrose interstitielle diffuse, 16. Syndrome d'apnée de sommeil 32. Dyspnée d’effort ≥ niveau 2 64. Asthme 128. Atopie 256. BPCO 512. autres………………

18.Traitement en cours 0. Aucun 1. Broncho-dilatateurs 2. Corticoïde 4. Muco-modificateurs 8. Antitussifs 16. Analeptique 32. Antituberculeux 64. Autres………………

19. Maladie cardiovasculaire: 0 Non 1 Oui; Si oui passer aux questions 20 et 21

20. Pathologie 1. Angine de poitrine 2. Infarctus du myocarde 4. Insuffisance cardiaque 8. Trouble du rythme cardiaque 16. Artérite des membres inférieurs 32. Autres……………………………………………………...

21. Traitement 0. Aucun 1. Dérivé nitré 2. Anti-arythmique 4. Inhibiteur calcique 8. Anti-ischémique 16. Digitalique 32. Bêtabloquant 64. Antiagrégant plaquettaire 128. Inhibiteur de l’enzyme de conversion 256.Anti-vitamine K 512. Autres………………

22. Hypertension artérielle: 0 Non 1 Oui ; Si oui, passer aux questions 23-25

23. Ancienneté (année :… …24 Stabilité: 0 Stable 1 Instable

25. Traitements en cours 1. Régime 2. Bêtabloquants 4. Antihypertenseur central 5. Inhibiteur calcique 6. Diurétique 7. Inhibiteur de l’enzyme de conversion 8. Vasodilatateur 9. Autres…………………………………….

26. Avez-vous une dyslipidémie? 0. Non 1. Oui ; Si oui passer à la question

27. Traitements:1 Régime 2 Hypolipémiant

28. Avez-vous un diabète? 0. Non 1. Oui…29. Avez-vous une anémie? 0. Non 1. Oui 30. Avez-vous une dysthyroïdie? 0. Non 1. Oui

31. Avez-vous un néoplasie? 0. Non 1. Oui 32. Avez-vous une maladie systémique? 0. Non 1. Oui

33. Hospitalisations médicales antérieures ; Si oui, passer aux questions 34 et 35

34. Services 1 ……… … 2 …… … ………3 …… ……35 Diagnostics 1 ……………… 2 ……………………… 3 ………………

36.Antécédents chirurgicaux: 0. Non 1. Abdomino-pelviens 2. Urologiques 4. Thoraciques 8. Orthopédiques 16. Neurochirurgicaux 32. Autres:…

37. Nombre de grossesses menées à terme,nombre d’avortements, nombre d’enfants: / /

Habitudes et mode de vie

38. Avez-vous fumé des cigarettes? 0. Non 1. Oui , Si oui, passer aux questions 39 et 40

39. Nombre de cigarettes par jour/an:………40 Si vous avez arrêté de fumer, depuis quand (années :……………

41. Fumez-vous la chicha? 0 Non 1 Oui ; Si oui, passer à la question 42

42. Nombre de chicha par jour/an: … …43 Consommation d’Alcool: 0 Non 1 Oui

SECTION B. CHRONIC LIVER DISEASE QUALITY OF LIFE QUESTIONNAIRE (CLDQ) (IN ARABIC)

استبيان مرض الكبد المزمن (CLDQ) - جودة مؤشر الحياة للمرضى الذين يعانون من مرض الكبد المزمن

تم تصميم هذا الاستبيان لمعرفة كيفاش كان شعورك خلال الأسبوعين الماضيين. سيتم سؤالك عن الأعراض المرتبطة بمرض الكبد، كيفاش تأثرت في القيام بالأنشطةاليومية، و كيفاش كان تأثيرها على حالتك المزاجية. يرجى استكمال جميع الأسئلة وتحديد إجابة واحدة فقط لكل سؤال.

السؤال: في الجمعتين اللي تعداو قداش من مرة

ديما

معضم الوقت

ساعات

القليل من الوقت

دوب من بلاش

تقريبا أبدا

أبدا

1. حسيت بقلق متع نفاخ في كرشك؟

.٢حسيت روحك تاعب؟

.٣حسيت بوجيعة في بدنك؟

.٤جاك النوم و مازال الليل ماجاش؟

.٥جاتك وجيعة في كرشك؟

.٦ حسيت بضيق النفس سبّبك قلق في أعمالك اليومية؟

.٧ ما نجمتش تاكل كمية الماكلة الي حبيت تاكلها؟

.٨تقّلقت على خاطرقوتك قاعدة تنقص؟

.٩ لقيت مشكلة بش تهز وإلا تحرك حاجة رزينة؟

.١٠ حسيت روحك متقلق و مش قد بعضك؟

.١١ حسيت بالفشلة وقلة الجهد؟

.١٢ حسيت روحك مش فرحان؟

.١٣ حسيت روحك ناعس؟

.١٤تقلقت على خاطر ماكلتك محدودة؟

.١٥حسيت روحك فيسع تتنرفز؟

16.لقيت صعوبة بش ترقد في الليل؟

.١٧حسيت بقلق وعدم راحة في كرشك؟

.١٨حيرك من تاثير مرض كبدتك على عائلتك؟

.١٩ حسيت روحك فيسع تتقلب و كل ساعة و علمها؟

.٢٠ماتنجمش ترقد فيسع في الليل؟

.٢١شدّتك الكرمب (تكبيشة)؟

.٢٢خفت لا الأعراض اللي عندك تطور لمشكلة أكبر؟

.٢٣ حسيت ريقك شايح؟

.٢٤ حسيت بالاكتئاب؟

25. اتقلقت لا حالتك تزيد تتدهور؟

.٢٦ لقيت عندك مشكلة في التركيز؟

.٢٧ عانيت من الحكة في بدنك؟

.٢٨ خفت لا حالتك معادش تتحسن؟

.٢٩تحيرت في صورة ما إذا إستحقيت زرع كبد زعما تلقى وإلاّ لا؟
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SECTION C. VOORRIPS PHYSICAL ACTIVITY QUESTIONNAIRE (IN ARABIC)

الأنشطة اليومية داخل المنزل .I

هل تقوم بالأعمال المنزلية الخفيفة؟ (غسيل الأواني، إزالة الغبار، خياطة الملابس، إلخ

لا (أقل من مرة في الشهر

١أحيانا ( فقط عندما لا يمكن لقريني أو لطرف ثالث القيام بها

٢غالب الوقت (بعون من قريني أو طرف ثالث

٣دائما (وحدي أو مع قريني

2 (هل تقوم بالأعمال المنزلية المجهدة؟ (تنظيف الأرضية و الشبابيك،إخراج سلة المهملات،إلخ .. )

٠لا (أقل من مرة في الشهر

١أحيانا ( فقط عندما لا يمكن لقريني أو لطرف ثالث القيام بها

٢غالب الوقت (بعون من قريني أو طرف ثالث

٣دائما (وحدي أو مع قريني

3) كم من شخص يقيم معك في المنزل؟ (اجب بصفر إذ أجبت ب &quot;لا &quot; على السؤالين الأول والثاني )

4) كم تتعهد من غرفة بالتنظيف في المنزل الذي تقيم فيه؟ (باحتساب المطبخ، غرفة النوم، المستودع، القبو٫ غرفة الاستحمام، إلخ .. )

٠أنا لا أقوم أبدا بالتنظيف

١من 1 إلى 6 غرف

٢من 7 إلى 10 غرف

٣أكثر من 10 غرف

5) على كم من طابق تتوزع تلك الغرف؟ (اجب بصفر إذ أجبت ب &quot;لا &quot; على السؤالين الأول والثاني )

6) هل تحضر أطعمتك الساخنة أو تشارك في تحضيرها؟

٠لا بتاتا

١أحيانا (مرة أو مرتان في الأسبوع

غالب الوقت (ثلاث أو أربعة مرات في الأسبوع

دائما (أكثر من خمس مرات في الأسبوع

كم عدد درجات السلم التي تصعدها في اليوم؟ (بحساب العشرات

٠لا أصعد السلالم بتاتا

١من 1 إلى5

٢من 6 إلى 10

٣أكثر من 10

عند خروجك من المنزل ماهي وسائل النقل التي تستعملها؟

لا أخرج بتاتا من المنزل

١السيارة

وسائل النقل العمومية (الحافلة، تاكسي، سيارة الأجرة

الدراجة الهوائية أو النارية

المشي

كم من مرة تخرج للتسوق في الأسبوع؟

أقل من مرة

١مرة فقط

من 2 إلى 4

كل يوم تقريبا

عند التسوق ما هي وسائل النقل التي تستعملها؟

لا اخرج بتاتا للتسوق

١السيارة

وسائل النقل العمومية (الحافلة، تاكسي، سيارة الأجرة

الدراجة الهوائية أو النارية

المشي

II (الأنشطة الرياضية

هل تمارس الرياضة؟ نعم □ لا □

لرياضة الأولى

الاسم ....................................................

عدد الساعات في الأسبوع ..........................

عدد الأشهر في السنة .................................

درجة الحدة .............................................

الرياضة الثانية

الاسم .....................................................

عدد الساعات في الأسبوع ...........................

عدد الأشهر في السنة .................................

درجة الحدة .............................................

الرياضة الثالثة

الاسم ....................................................

عدد الساعات في الأسبوع ............................

عدد الأشهر في السنة .................................

درجة الحدة .............................................

الرياضة الرابعة

الاسم ....................................................

عدد الساعات في الأسبوع ............................

عدد الأشهر في السنة .................................

درجة الحدة .............................................

(IIIالأنشطة الترفيهية

هل تمارس أنشطة ترفيهية؟ نعم □ لا □

النشاط الأول

الاسم ............................................

عدد الساعات في الأسبوع .................

عدد الأشهر في السنة ........................

درجة الحدة .....................................

النشاط الثاني

الاسم ............................................

عدد الساعات في الأسبوع .................

عدد الأشهر في السنة ........................

درجة الحدة ....................................

النشاط الثالث

الاسم ............................................

عدد الساعات في الأسبوع .................

عدد الأشهر في السنة ........................

درجة الحدة ............

النشاط الرابع

الاسم ............................................

عدد الساعات في الأسبوع .................

عدد الأشهر في السنة ........................

درجة الحدة . .......................

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