Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1

Not Applicable

Completed

• Conditions: Myotonic Dystrophy 1

• Registration Number: NCT04018820
• Lead Sponsor: Élise Duchesne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-06-22
• Study Completion: 2018-06-22
• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Changes in maximal isometric muscle strength of the knee extensors	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 Outcome Measures

Name	Time	Method
Changes in maximal isometric muscle strength of the knee flexors	At baseline and week 12	Changes in maximal isometric muscle strength of the knee flexors measured by quantified muscle testing using a handheld dynamometer
Changes in 1-repetition maximum strength of the leg extension exercise	At baseline, week 6 and week 12	Changes in 1-repetition maximum strength of the leg extension exercise
Changes in maximal isometric muscle strength of the hip extensors	At baseline and week 12	Changes in maximal isometric muscle strength of the hip extensors measured by quantified muscle testing using a handheld dynamometer
Changes in maximal isometric muscle strength of the ankle dorsiflexors	At baseline and week 12	Changes in maximal isometric muscle strength of the ankle dorsiflexors measured by quantified muscle testing using a handheld dynamometer
Changes in the score of the myotonic dystrophy health index	At baseline, week 6, week 12, month 6 and month 9	Changes in the score of the myotonic dystrophy health index (MDHI). The MDHI is a 114-item questionnaire scored from 0 to 100, where 0 means no disability and 100 means maximal disability.
Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics	At baseline and week 12	Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics (RNA expression analysis)
Changes in muscle biopsy of the vastus lateralis: mitochondrial function	At baseline and week 12	Changes in muscle biopsy of the vastus lateralis: mitochondrial function. Analysis of mitochondrial markers and enzymes
Changes in maximal isometric muscle strength of the hip flexors	At baseline and week 12	Changes in maximal isometric muscle strength of the hip flexors measured by quantified muscle testing using a handheld dynamometer
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 leg press exercise
Changes in 1-repetition maximum strength of the hip abduction exercise	At baseline, week 6 and week 12	Changes in 1-repetition maximum strength of the hip abduction exercise
Changes in the Well-Being Manifestations Measure Scale	At baseline, week 6, week 12 and month 6	Changes in the Well-Being Manifestations Measure Scale (WBMMS). The WBMMS is a 25-item questionnaire where each question is scored on a scale from 1 to 5. A high score means high well-being.
Changes in muscle biopsy of the vastus lateralis: muscle fiber typing	At baseline and week 12	Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
Changes in the score of the lower extremity functional scale	At baseline, week 12, month 6 and month 9	Changes in the score of the lower extremity functional scale (LEFS). The LEFS is an 80-point questionnaire with 20 items scored from 0 to 4. A score of 80 means no disfunction while a score of 0 means maximal disfunction.
Changes in muscle biopsy of the vastus lateralis: Nuclear foci	At baseline and week 12	Changes in muscle biopsy of the vastus lateralis: Nuclear foci (changes in accumulation of nuclear foci)
Changes in 1-repetition maximum strength of the squat exercise	At baseline, week 6 and week 12	Changes in 1-repetition maximum strength of the squat exercise
Changes in comfortable walking speed in the 10-meter walk test	At baseline, week 6, week 12, month 6 and month 9	Changes in comfortable walking speed in the 10-meter walk test
Changes in maximal 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
Changes in the Hospital Anxiety and Depression Scale	At baseline, week 6, week 12 and month 6	Changes in the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire with a scale from 0 to 3 for each item. A high score means high depression and anxiety.
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 fiber size (smallest diameter of the fiber)
Changes in the Marin apathy scale	At baseline, week 12, month 6 and month 9	Changes in the Marin apathy scale. The Marin apathy scale is scored by the clinician where he interviews the subject and then scores an 18-item list on a scale of 1 to 4. A high score means more apathy.
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 number of repetitions in the 30-seconds sit-to-stand test
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 score of the Fatigue and Daytime Sleepiness Scale (FDSS). The FDSS is a 12-item questionnaire where all questions are scored from 0 to 2. A higher score means more daytime sleepiness and fatigue.
Changes in muscle biopsy of the vastus lateralis: muscle proteomics	At baseline and week 12	Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)

Trial Locations

Locations (1)

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires; 🇨🇦 Saguenay, Quebec, Canada