Effects of a 12-week Strength Training Program in Women With Myotonic Dystrophy Type 1
- Conditions
- Myotonic Dystrophy 1
- Interventions
- Other: Training program
- Registration Number
- NCT05400629
- Lead Sponsor
- Université de Sherbrooke
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
- 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.
- 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
- Arm && Interventions
Group Intervention Description Training program Training program 12-week strength training program of the lower limbs consisting of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. All exercises will be perform between 6 and 8 maximal repetitions.
- Primary Outcome Measures
Name Time Method Changes in maximal isometric muscle strength of the knee extensors At baseline, week 6, week 12, month 3 and month 6 Changes in maximal isometric muscle strength of the knee extensors measure by quantify muscle testing using a handheld dynamometer
- Secondary Outcome Measures
Name Time Method 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 maximal isometric muscle strength of the hip flexors At baseline and week 12 Changes in maximal isometric muscle strength of the hip flexors measure by quantify muscle testing using a handheld dynamometer
Changes in maximal isometric muscle strength of the hip abductors At baseline and week 12 Changes in maximal isometric muscle strength of the hip abductors measure by quantify muscle testing using a handheld dynamometer
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: 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 time to perform the Timed stair test At baseline, week 6, week 12, month 6 and month 9 Changes in the time to perform the Timed stair test
Self-perceived changes in daily life At week 12 Self-perceived changes in daily life
Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.) At baseline and week 12 Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)
Changes in maximal isometric grip strength At baseline and week 12 Changes in maximal isometric muscle strength of prehension measure by quantify muscle testing using a hand grip dynamometer
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 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 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 proteomics At baseline and week 12 Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)
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 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 maximal isometric muscle strength of the hip extensors At baseline and week 12 Changes in maximal isometric muscle strength of the hip extensors measure by quantify 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 squat exercise At baseline, week 6 and week 12 Changes in 1-repetition maximum strength of the squat exercise
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 time to perform of the Timed Up and Go At baseline, week 6, week 12, month 6 and month 9 Changes in the time to perform of the Timed Up and Go
Change in the score of the Brief Pain Inventory At baseline, week 6, week 12, month 6 and month 9 Change in the score of the Brief Pain Inventory. The Brief Pain Inventory is a self-administer test that asses the dimensions of pain such as intensity of pain, functional incapacities, social and family repercussions, and psychological distress.
Change in saliva sample : exercise biomarkers (-Omics markers) At baseline and week 12 Change in saliva sample : exercise biomarkers (-Omics markers)
Change of the center of pressure (COP) measure in static posturography : closed eyes bipodal position At baseline, week 6, week 12, 6 months and 9 months Change of the center of pressure (COP) in static posturography : closed eyes bipodal position
Change of the center of pressure (COP) measure in static posturography : open eyes semi-tandem position At baseline, week 6, week 12, 6 months and 9 months Change of the center of pressure (COP) in static posturography : open eyes semi-tandem position
Change of the center of pressure (COP) measure in static posturography : open eyes tandem position At baseline, week 6, week 12, 6 months and 9 months Change of the center of pressure (COP) in static posturography : open eyes tandem position
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 measure by quantify muscle testing using a handheld dynamometer
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 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 maximal isometric muscle strength of the ankle dorsiflexors At baseline and week 12 Changes in maximal isometric muscle strength of the ankle dorsiflexors measure by quantify 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 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 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.
Change in the number of falls At baseline, week 12, month 6 ans month 9 Number of falls in the last week and in the last month
Change in score of the DM1-Activ questionnaire At baseline, week 6, week 12, month 6 ans month 9 Change in score of the DM1-Activ questionnaire. This questionnaire asses activity and social participation with DM1 population. It contains 20 items with a maximal socre of 40 points, a lower score represent a bigger impact of the disease on activities and social participation.
Change in urine sample : exercise biomarkers (-Omics markers) At baseline and week 12 Change in urine sample : exercise biomarkers (-Omics markers)
Change of the center of pressure (COP) measure in static posturography : open eyes bipodal position At baseline, week 6, week 12, 6 months and 9 months Change of the center of pressure (COP) in static posturography : open eyes bipodal position
Trial Locations
- Locations (1)
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
🇨🇦Saguenay, Quebec, Canada