Beaudoin 2017.
Methods | Design: single‐centre, open‐label, parallel RCT (the record on clinicaltrials.gov states cross‐over design, but this is not evident from published paper). Inclusion criteria: participants with CF; age > 18 years; sedentary (less than 100 min/week of structured exercise assessed by physical activity questionnaire and phone interview; FEV1 > 40 % predicted; clinically stable for the last 6 weeks; IGT; CFRD without pharmacological treatment or elevated 1‐h plasma glucose concentration during an oral glucose tolerance test (indeterminate 1‐h glucose concentration of > 11.0 but 2‐h plasma glucose concentration < 7.8 mmol/L‐1). Exclusion criteria: current pulmonary exacerbation; use of oral or intravenous corticosteroids; low SaO2 during exercise; history of haemoptysis in the last 6 weeks. |
|
Participants | 14 participants with CF. Group demographics Exercise group (n = 8): mean (range) age 31.9 (24; 41) years. Control groups (n = 6): mean (range) age 35.5 (22; 57) years. |
|
Interventions | 12‐week combined aerobic and resistance training study. Exercise group: aerobic and resistance training exercises 3x per week for about 20 ‐ 40 minutes with a day off between the training sessions (in total 36 training sessions). Exercise intensity and volume were progressively increased. Participants recorded their training sessions in a diary. Once every 4 weeks, participants received a supervised training session and a phone call on a weekly basis.
Control group: no information was reported in the original publication. Detailed information on control intervention is available on clinicaltrials.gov. |
|
Outcomes | Included in this study were: pulmonary function (FVC, FEV1); metabolic parameters (HbA1c, plasma glucose area under the curve, insulin sensitivity index, plasma insulin area under the curve (0 ‐ 120 min); exercise capacity measured by a cycle cardiopulmonary exercise test (VO2 peak and VE at VO2 peak); muscle strength (leg press, chest press, latpull down, biceps curl) and endurance (push‐up, sit‐up, flexibility, handgrip strength); body composition (bodyweight, BMI, body fat and fat‐free mass); HRQoL and objectively measured physical activity (steps per days; energy expenditure) and assessed by questionnaire. Further, inflammatory markers were measured in this study (e.g., IL‐1; IL‐6; IL‐8; YKL‐40 and CRP‐hs) but inflammatory biomarkers are not outcomes relevant for this review. |
|
Notes |
Study registration: The study was registered as cross‐over trial (Clinicaltrials.gov NCT02127957) but results were reported as parallel‐design study. The authors confirmed that they had to stop the study due to recruitment problems. The authors presented only results from the first study phase (12 weeks). Information provided on clinicaltrials.gov "Intervention Model: Crossover Assignment" "Following the visit #6, patients in the control group will be invited to participate in a second study phase to participate in supervised exercise program. This participation will involve an additional 12 weeks of follow‐up, which included the same visit as Group 1 with exercises. In this case, to simplify participation and reduce the volume of blood collected, the final visit (#5) of the project will also be the first visit of exercises phase. This part of study, involves 2 supervised training sessions and 8 follow up phone call. The exercises program will be performed three times per week for about one hour." |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned open‐label study with two parallel arms. Randomisation was conducted in blocks by gender with a ratio of 2:2. No details given for generation of sequence. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not possible to blind participants to intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether outcome assessors blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | At screening,1 participant could not be randomized due to an adverse event during cardiopulmonary exercise testing. There were 3 dropouts post‐randomisation (18%).
The study was registered as crossover study but results for the second study part were not presented. |
Selective reporting (reporting bias) | High risk | Heart rate and SaO2 were measured during cardiopulmonary exercise testing, but results were not reported. The second study phase was not reported in the original publication. |
Other bias | High risk |
Sample size Information on sample size and recruitment goals differ between the information provided under Clinicaltrials.gov and the final publication. This study aimed to recruit 24 participants (12 exercise group, 12 control group), see Clinicaltrials.gov, NCT02127957. The recruitment goal was not achieved (N = 18 were recruited but only 17 randomised ), but no information was provided in the final paper. According to the power calculation provided in the original publication, 18 participants (9 per group) were required for the analysis. Finally, 14 participants completed the study so the study is likely to be underpowered. Statistical analyses The authors reported pre‐post within‐group changes and no between‐group differences as would be appropriate for a RCT. We received raw data from the authors and calculated between‐group differences for plasma glucose and plasma insulin values during the oral glucose tolerance test. Our results differ compared to the results reported in the original publication. The initial power analysis, aiming to demonstrate a difference of 1.5 mmol/L in plasma glucose levels 120 minutes after ingestion of the glucose solution after exercise training required a study sample of 18 participants (9 per group). Finally, only 14 participants completed the study that reduces the statistical power to observe a difference between the interventions in the study. Control intervention In the original publication, no information was provided on the control intervention. We noticed discrepancies between the registered (clinicaltrials.gov) and published trial design (cross‐over versus parallel‐group design). |