Clinical trial NCT04018820: Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Official title: Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myotonic Dystrophy 1
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fondation du Grand défi Pierre Lavoie
First posted: 2019-07-15
Enrollment: 11
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Participants had to complete a 12-week strength training program and return to their normal activities for the following 6 months after the end of the training program
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in maximal isometric muscle strength of the knee extensors
timeFrame: At baseline, week 6, week 12, month 6 and month 9
Secondary outcomes:
measure: Changes in maximal isometric muscle strength of the knee flexors
timeFrame: At baseline and week 12
measure: Changes in maximal isometric muscle strength of the hip flexors
timeFrame: At baseline and week 12
measure: Changes in maximal isometric muscle strength of the hip extensors
timeFrame: At baseline and week 12
measure: Changes in maximal isometric muscle strength of the ankle dorsiflexors
timeFrame: At baseline and week 12
measure: Changes in 1-repetition maximum strength of the leg extension exercise
timeFrame: At baseline, week 6 and week 12
measure: Changes in 1-repetition maximum strength of the leg press exercise
timeFrame: At baseline, week 6 and week 12
measure: Changes in 1-repetition maximum strength of the hip abduction exercise
timeFrame: At baseline, week 6 and week 12
measure: Changes in 1-repetition maximum strength of the squat exercise
timeFrame: At baseline, week 6 and week 12
measure: Changes in comfortable walking speed in the 10-meter walk test
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Changes in maximal walking speed in the 10-meter walk test
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Changes in the number of repetitions in the 30-seconds sit-to-stand test
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Changes in the score of the lower extremity functional scale
timeFrame: At baseline, week 12, month 6 and month 9
measure: Changes in the score of the myotonic dystrophy health index
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Changes in the score of the Fatigue and Daytime Sleepiness Scale
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Changes in the Marin apathy scale
timeFrame: At baseline, week 12, month 6 and month 9
measure: Changes in the Well-Being Manifestations Measure Scale
timeFrame: At baseline, week 6, week 12 and month 6
measure: Changes in the Hospital Anxiety and Depression Scale
timeFrame: At baseline, week 6, week 12 and month 6
measure: Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
timeFrame: At baseline and week 12
measure: Changes in muscle biopsy of the vastus lateralis: muscle fiber size
timeFrame: At baseline and week 12
measure: Changes in muscle biopsy of the vastus lateralis: muscle proteomics
timeFrame: At baseline and week 12
measure: Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics
timeFrame: At baseline and week 12
measure: Changes in muscle biopsy of the vastus lateralis: mitochondrial function
timeFrame: At baseline and week 12
measure: Changes in muscle biopsy of the vastus lateralis: Nuclear foci
timeFrame: At baseline and week 12
Other outcomes:
Locations:
city: Saguenay
country: Canada
facility: Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
state: Quebec
Study officials:
affiliation: Université du Québec à Chicoutimi
name: Elise Duchesne, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: