Kierkegaard 2011.
| Methods | Evaluator‐blind, parallel‐group RCT | |
| Participants |
Sample size Intervention group: 18 adults with myotonic dystrophy type 1, control group: 17 adults with myotonic dystrophy type 1 Inclusion criteria Diagnosed DM1; living in the Stockholm County Council area; aged ≥ 18 years; ability to walk 50 m without assistance; permission from a cardiologist to take part in an exercise programme; and classified as grade 2–5 on the MIRS Exclusion criteria Inability to communicate in Swedish; clinically obvious severe cognitive impairment; and other diagnoses that could interfere with participation. Of 114 eligible persons, 35 did not fulfil the inclusion criteria (24 were unable to walk 50 m, 4 were classified as MIRS 1, 4 had severe cardiac arrhythmia, 2 had other concurrent diagnoses and 1 did not speak Swedish). Baseline demographics The training group comprised 10 women and 8 men, mean age 44 years, standard deviation (SD) 11, range 20–60 years. The control group comprised 10 women and 7 men, mean age 41 years, SD 15, ranging from 20‐65 |
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| Interventions | Strength training and aerobic exercise training vs no training Type of training and exercise Strength training, aerobic exercise, balance exercises, supported by music Intensity Strength exercises for arm, leg, back and abdominal muscles 16‐20 repetitions, for 6‐7 min, balance exercises for 3‐4 min, aerobic activities for 11‐12 min at 60%‐80% of maximum heart rate. Once a week a 30‐min brisk walk Frequency 2 times/week and once a week a brisk walk Setting The department of physical therapy, Karolinska University Hospital (Sweden) Duration Session: 60 min and a 30‐min walk. Programme: 14 weeks Muscle groups Arm, leg, back and abdominal muscles Supervision All sessions were supervised by a specialised physiotherapist |
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| Outcomes |
Primary Distance walked in the 6‐min walk test Secondary Timed‐stands test, timed up‐and‐go test Time‐points measured Before and after a control or training period of 14 weeks |
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| Dates | Study dates not reported | |
| Funding/ declarations of interest | "This research was supported by grants from the Einar Belvén Foundation, the Norrbacka‐Eugenia Foundation, Stockholm, the Swedish Association of Registered Physiotherapists and the Swedish Association for Persons with Neurological Disabilities (NHR). Financial support was also provided through the strategic research programme in Care Sciences (SFP‐V), Karolinska Institutet, and the regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet." | |
| Notes | Participants were stratified before randomisation by their results in the 6‐min walk test | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The lots were drawn by a person who was not involved in any other part of the study" |
| Allocation concealment (selection bias) | Low risk | Quote: "Participants were recruited before randomisation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible: intervention was training vs no training |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Data was collected before and after the intervention by two independent experienced physiotherapists, blinded to group allocation and each assessing the same participants on both occasions" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "one person in the control group did not attend the data collection after the intervention" |
| Selective reporting (reporting bias) | Low risk | Comment: no evidence found for selective reporting |
| Other bias | Low risk | Comment: no risk of bias from other sources detected |