Lindeman 1995.
| Methods | Evaluator‐blind, matched‐control RCT | |
| Participants |
Sample size Intervention group (number randomised): 21 adults with myotonic dystrophy type 1, control group 15 adults with myotonic dystrophy type 1 Inclusion criteria Participants diagnosed with myotonic dystrophy on the basis of their clinical picture, electromyography and nerve conduction studies Exclusion criteria Participants were excluded if there were contraindications for muscle strengthening exercises or if they had other disabling disorders that might influence the scoring in the functional tests. Baseline demographics Of the 33 myotonic dystrophy participants who ultimately started the trial, 2 had the congenital form; the others had the classical, adult type. All participants were ambulatory. |
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| Interventions | Strength training vs no training Type of training and exercise Dynamic strength training with weights Intensity Individualised progressive overload, 3 sets from 25 repetitions at 60% of 1RM, via 15 repetitions at 70%, to 10 repetitions at 80% Frequency 3 times/week Setting At home (the Netherlands) Duration Session: within 30 min. Programme: 24 weeks Muscle groups Knee extensors and flexors, hip extensors and abductors Supervision Supervised home training programme |
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| Outcomes |
Primary Muscle strength by isokinetically measured knee torques and isometrically as MVIC. Secondary Endurance by maximum duration of contraction at 80% of MVIC, functional performance by timed motor performance tests and by questionnaires. Serum myoglobin levels to detect changes in muscle fibre membrane permeability Time‐points measured Outcome measurements were performed at the start of the study period (t0) and after 8 (t8), 16 (t16), and 24 (t24) weeks of follow‐up. |
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| Dates | Study dates not reported | |
| Funding/ declarations of interest | Study authors have chosen not to select a disclosure statement | |
| Notes | Participants were matched based on muscle strength (knee extension torque/body weight) and on performance in a stair‐climbing test. Only complete pairs were analysed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: there was no published information on the sequence generation but the study author (Lindeman) informed us that 2 independent persons drew a sealed lot per matched pair and allocated each pair to the training or non‐training group by tossing a coin. There was some baseline imbalance but we considered it consistent with chance. |
| Allocation concealment (selection bias) | Low risk | Comment: there was no published information on the method of allocation concealment but the study author (Lindeman) informed us that 2 independent persons allocated the training, after tossing the coin, to the training or non‐training group |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not blinded as it is impossible to blind exercise training compared to no exercise training |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "observers of the outcome measurements were blinded for treatment allocation" Comment: approximately 20% of the myotonic dystrophy participants revealed information to the clinical evaluators that resulted in unblinding during the course of the trial |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 3 of the initially 36 randomised participants withdrew before disclosure of treatment allocation. The 33 participants starting the trial made 15 matched pairs. During the trial 1 person dropped out. Because of the matched pair design only complete pairs were analysed, therefore eventually 28 of the initial 36 randomised participants were analysed. Follow‐up was therefore incomplete and analysis was not by ITT. However, the flow path of participants was well documented |
| Selective reporting (reporting bias) | High risk | Quote: "Differences were compared using paired T tests and two sample T tests (to look for differences because of the small number of complete pairs). Only results of the paired T tests at t0 and t24 will be presented because they showed the most relevant differences between the groups." Comment: appears to be a high risk of selective reporting |
| Other bias | Low risk | Comment: no risk of bias from other sources detected |