Clinical trial NCT05400629: Effects of a 12-week Strength Training Program in Women With Myotonic Dystrophy Type 1
Official title: Effects of a 12-week Strength Training Program in Women 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: Rare Disease Foundation
First posted: 2022-06-01
Enrollment: 12
Sex: FEMALE
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 will 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: 20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength training program. The training program consist 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 will be closely supervise and take place twice a week. It is hypothesize that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants will be evaluated at baseline, week 6, week 12, month 6 and month 9 to quantify the effects of the training program and if these effects will be maintained over time.


Eligibility criteria: Inclusion Criteria:

* DM1 diagnosis must be confirmed by genetic analysis;
* Women sex, 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 3 and month 6
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 hip abductors
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 maximal isometric grip strength
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 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
measure: Changes in the time to perform of the Timed Up and Go
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Changes in the time to perform the Timed stair test
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Change in the score of the Brief Pain Inventory
timeFrame: At baseline, week 6, week 12, month 6 and month 9
measure: Self-perceived changes in daily life
timeFrame: At week 12
measure: Change in the number of falls
timeFrame: At baseline, week 12, month 6 ans month 9
measure: Change in score of the DM1-Activ questionnaire
timeFrame: At baseline, week 6, week 12, month 6 ans month 9
measure: Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)
timeFrame: At baseline and week 12
measure: Change in urine sample : exercise biomarkers (-Omics markers)
timeFrame: At baseline and week 12
measure: Change in saliva sample : exercise biomarkers (-Omics markers)
timeFrame: At baseline and week 12
measure: Change of the center of pressure (COP) measure in static posturography : open eyes bipodal position
timeFrame: At baseline, week 6, week 12, 6 months and 9 months
measure: Change of the center of pressure (COP) measure in static posturography : closed eyes bipodal position
timeFrame: At baseline, week 6, week 12, 6 months and 9 months
measure: Change of the center of pressure (COP) measure in static posturography : open eyes semi-tandem position
timeFrame: At baseline, week 6, week 12, 6 months and 9 months
measure: Change of the center of pressure (COP) measure in static posturography : open eyes tandem position
timeFrame: At baseline, week 6, week 12, 6 months and 9 months
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: