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. 2016 Dec 3;2016(12):CD010637. doi: 10.1002/14651858.CD010637.pub2

Hartmann 1997.

Methods Aim: To determine the potential long‐term effects of a programme of combined physical therapy consisting of exercises, external compression and brief cold stimuli on venous circulation in the legs and on participants' symptoms
Duration of participation: 24 weeks
Frequency of intervention: 2 days/week
Inclusion criteria: Individuals suffering from manifest varicose veins in both lower extremities with increased venous capacity, as determined by strain‐gauge plethysmography (SGP), and reduced venous filling time as determined by photoplethysmography
Exclusion criteria: Concomitant heart or arterial disease, orthopaedic disorders of the lower extremities, or vasoactive medication
Participants Total no. randomised: 24 (intervention = 12; control = 11 + 1 dropout)
Age: 31 to 71 years (mean ± SD: 54.7 ± 3.2)
Gender: 17 women, 7 men
Severity of disease: not reported
Interventions Intervention: 60 minutes of exercise (2 days per week), first 20 minutes in an exercise bath (water level 135 cm, hydrostatic pressure 100 mmHg, water temperature 34ºC), then the legs were doused with cold water for 30 seconds and followed by 25 minutes of floor exercises. The exercises were designed to improve breathing and the efficiency of muscle and joint pumps
Co‐interventions: Compression stockings (30 mmHg) during exercises. Unsupervised exercise once a day for 15 minutes
Outcomes Outcomes relevant for this review
Primary outcomes:
1. Intensity of disease signs and symptoms: The authors used a non‐validated tool
2. Ejection fraction: Not reported
3. Venous refilling time (mean ± SD): Increased in the treatment group. After treatment, half refilling time was 11.3 ± 0.9 seconds in the intervention group compared with 7.1 ± 1.3 seconds in the control group (P < 0.001). Total refilling time in intervention group was 25.7 ± 2.1 compared with 16.3 ± 1.9 (P < 0.001) in the control group
4. Incidence of venous leg ulcer: Not reported
Secondary outcomes:
1. Quality of life: Not reported
2. Exercise capacity: Not reported
3. Muscle strength: Not reported
4. Incidence of surgical intervention to treat symptoms related to CVI: Not reported
5. Ankle joint mobility: Not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "After receiving detailed information about test procedures, they were randomized into two groups. For the purpose of the study these two groups formed matched pairs, corresponding to one another in all relevant measurement parameters". There is no mention on how they were matched.
Allocation concealment (selection bias) High risk "After receiving detailed information about test procedures, they were randomized into two groups. For the purpose of the study these two groups formed matched pairs, corresponding to one another in all relevant measurement parameters"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk The authors do not mention if there was blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The authors do not mention blinding of outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes High risk "During the study there was 1 dropout from the control group who declined to submit to further control measurements"
Selective reporting (reporting bias) High risk In the measurement section of the study report, the study authors say, "After a fifteen minute rest period, two measurements each of venous capacity and maximum venous outflow were made at intervals of five minutes by means of a strain‐gauge plethysmograph". But there are no reports of maximum venous outflow
Other bias High risk Unit of analysis are extremities and not subjects