Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Changes in maximal isometric muscle strength of the knee extensors
Study Overview
Brief Summary
Eleven men with myotonic dystrophy type 1 (DM1) underwent a 12-week lower-limb strength training program. The training program consisted of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. Training sessions were closely supervised and took place twice a week. It is hypothesised that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants were evaluated at baseline, week 6, week 12, month 6 and month 9 to see the effects of the training program and if these effects are maintained over time.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Most outcomes where not masked, however the outcome assessor was masked for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor did not know if it was from baseline or from after the training program.
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DM1 diagnosis must be confirmed by genetic analysis;
- •Male gender, aged between 30 and 65 years old;
- •Be able to walk without assistance;
- •Consent of the neurologist must be given to participate in this study;
- •Must reside in the Saguenay-Lac-St-Jean region;
- •Subjects must be able to give their consent freely and voluntarily.
Exclusion Criteria
- •Patients with any other form of muscular dystrophy are excluded;
- •Any contraindication for strenuous exercise or muscle biopsy.
Outcomes
Primary Outcomes
Changes in maximal isometric muscle strength of the knee extensors
Time Frame: At baseline, week 6, week 12, month 6 and month 9
Changes in maximal isometric muscle strength of the knee extensors measured by quantified muscle testing using a handheld dynamometer
Secondary Outcomes
- Changes in maximal isometric muscle strength of the knee flexors(At baseline and week 12)
- Changes in 1-repetition maximum strength of the leg extension exercise(At baseline, week 6 and week 12)
- Changes in maximal isometric muscle strength of the hip extensors(At baseline and week 12)
- Changes in maximal isometric muscle strength of the ankle dorsiflexors(At baseline and week 12)
- Changes in the score of the myotonic dystrophy health index(At baseline, week 6, week 12, month 6 and month 9)
- Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics(At baseline and week 12)
- Changes in muscle biopsy of the vastus lateralis: mitochondrial function(At baseline and week 12)
- Changes in maximal isometric muscle strength of the hip flexors(At baseline and week 12)
- Changes in 1-repetition maximum strength of the leg press exercise(At baseline, week 6 and week 12)
- Changes in 1-repetition maximum strength of the hip abduction exercise(At baseline, week 6 and week 12)
- Changes in the number of repetitions in the 30-seconds sit-to-stand test(At baseline, week 6, week 12, month 6 and month 9)
- Changes in the score of the Fatigue and Daytime Sleepiness Scale(At baseline, week 6, week 12, month 6 and month 9)
- Changes in the Well-Being Manifestations Measure Scale(At baseline, week 6, week 12 and month 6)
- Changes in muscle biopsy of the vastus lateralis: muscle fiber typing(At baseline and week 12)
- Changes in the score of the lower extremity functional scale(At baseline, week 12, month 6 and month 9)
- Changes in muscle biopsy of the vastus lateralis: Nuclear foci(At baseline and week 12)
- Changes in 1-repetition maximum strength of the squat exercise(At baseline, week 6 and week 12)
- Changes in comfortable walking speed in the 10-meter walk test(At baseline, week 6, week 12, month 6 and month 9)
- Changes in maximal walking speed in the 10-meter walk test(At baseline, week 6, week 12, month 6 and month 9)
- Changes in the Hospital Anxiety and Depression Scale(At baseline, week 6, week 12 and month 6)
- Changes in muscle biopsy of the vastus lateralis: muscle fiber size(At baseline and week 12)
- Changes in muscle biopsy of the vastus lateralis: muscle proteomics(At baseline and week 12)
- Changes in the Marin apathy scale(At baseline, week 12, month 6 and month 9)
Investigators
Élise Duchesne
Sponsor-Investigator
Université de Sherbrooke