Carter 2014.
| Methods |
Design: random assignment to pragmatic exercise intervention + usual care (EX) or usual care (NEX) Setting: MS clinic, UK Categorization: EX = mixed |
|
| Participants |
n = 120; EX = 60, NEX = 60 Inclusion criteria: clinical diagnosis MS, EDSS 1‐6.5, able to walk 10 metres, aged 18‐65 years, clinically stable, and stable medical treatment < 3 months Exclusion criteria: structured exercise ≥ 3x per week, ≥ 30 minutes; living ≥ 20 minutes travelling from study centre, co‐morbid conditions precluding exercise participation Type MS: RRMS, SPMS, and PPMS Disease duration (yr) ± SD: EX = 8.4 ± 7.4, NEX = 9.2 ± 7.9 Mean age (yr) ± SD: EX = 45.7 ± 9.1, NEX = 46.8 ± 8.4 % Female (n/n group): EX = 43/60, NEX = 43/60 Mean EDSS ± SD: EX = 3.8 ± 1.5, NEX = 3.8 ± 1.5 |
|
| Interventions |
EX: 12 weeks, 3x per week; partly home based with more supervised sessions in the first 6 weeks of the intervention and vice‐versa in the second 6 weeks. Short bouts (5 x 3 minutes) of low to moderate intensity aerobic exercise at 50‐69% of predicted maximal heart rate or 12‐14 on the BORG scale. Participants were encouraged during the intervention period to increase the duration of the bouts or reduce the resting time in between bouts. When appropriate, participants could also perform 6 different resistance exercises using body resistance, light weights, or Therabands. Generally, 1‐3 sets of 20 repetitions based on the participant's level of disability, strength, and stage of the programme. In case of balance or control problems, also balance board and exercise ball work was included. The supervised exercise sessions included also cognitive behavioural techniques to promote long‐term physical activity behaviour NEX: usual care |
|
| Outcomes | MFIS, GLTEQ, Accelerometer, MSQoL‐54, MSFC, 6MWT, EDSS | |
| Notes |
Drop‐outs EX: 2 relapse, 2 ill health, 1 poor adherence, 6 unable to contact NEX: 1 relapse, 2 ill health, 1 work commitments, 1 no reason give, 5 unable to contact Measurements Baseline, 12 weeks, 6 months' follow‐up |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Distant randomization service; minimization according to gender and EDSS. Allocation not disclosed until after baseline measurement |
| Allocation concealment (selection bias) | Low risk | Independent and off‐site randomization service |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to the nature of the intervention, neither participants nor personnel could be blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Fatigue was self reported and therefore outcome assessment was not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out rate in the combined exercise group was 17%, in the control group 18%. No indication for differences in reasons |
| Selective reporting (reporting bias) | Low risk | Study protocol published |
| Other bias | Low risk | No other sources of bias identified |