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

Myotonic Dystrophy 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400629
• Other study ID #: 2022-005
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: February 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 10, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myotonic Dystrophy
• Myotonic Dystrophy 1

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Groupe de recherche interdisciplinaire sur les maladies neuromusculaires	Saguenay	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Rare Disease Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in maximal isometric muscle strength of the knee extensors	Changes in maximal isometric muscle strength of the knee extensors measure by quantify muscle testing using a handheld dynamometer	At baseline, week 6, week 12, month 3 and month 6
Secondary	Changes in maximal isometric muscle strength of the knee flexors	Changes in maximal isometric muscle strength of the knee flexors measure by quantify muscle testing using a handheld dynamometer	At baseline and week 12
Secondary	Changes in maximal isometric muscle strength of the hip flexors	Changes in maximal isometric muscle strength of the hip flexors measure by quantify muscle testing using a handheld dynamometer	At baseline and week 12
Secondary	Changes in maximal isometric muscle strength of the hip extensors	Changes in maximal isometric muscle strength of the hip extensors measure by quantify muscle testing using a handheld dynamometer	At baseline and week 12
Secondary	Changes in maximal isometric muscle strength of the hip abductors	Changes in maximal isometric muscle strength of the hip abductors measure by quantify muscle testing using a handheld dynamometer	At baseline and week 12
Secondary	Changes in maximal isometric muscle strength of the ankle dorsiflexors	Changes in maximal isometric muscle strength of the ankle dorsiflexors measure by quantify muscle testing using a handheld dynamometer	At baseline and week 12
Secondary	Changes in maximal isometric grip strength	Changes in maximal isometric muscle strength of prehension measure by quantify muscle testing using a hand grip dynamometer	At baseline and week 12
Secondary	Changes in 1-repetition maximum strength of the leg extension exercise	Changes in 1-repetition maximum strength of the leg extension exercise	At baseline, week 6 and week 12
Secondary	Changes in 1-repetition maximum strength of the leg press exercise	Changes in 1-repetition maximum strength of the leg press exercise	At baseline, week 6 and week 12
Secondary	Changes in 1-repetition maximum strength of the hip abduction exercise	Changes in 1-repetition maximum strength of the hip abduction exercise	At baseline, week 6 and week 12
Secondary	Changes in 1-repetition maximum strength of the squat exercise	Changes in 1-repetition maximum strength of the squat exercise	At baseline, week 6 and week 12
Secondary	Changes in comfortable walking speed in the 10-meter walk test	Changes in comfortable walking speed in the 10-meter walk test	At baseline, week 6, week 12, month 6 and month 9
Secondary	Changes in maximal 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
Secondary	Changes in the number of repetitions in the 30-seconds sit-to-stand test	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
Secondary	Changes in the score of the lower extremity functional scale	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.	At baseline, week 12, month 6 and month 9
Secondary	Changes in the score of the myotonic dystrophy health index	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.	At baseline, week 6, week 12, month 6 and month 9
Secondary	Changes in the score of the Fatigue and Daytime Sleepiness Scale	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.	At baseline, week 6, week 12, month 6 and month 9
Secondary	Changes in the Marin apathy scale	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.	At baseline, week 12, month 6 and month 9
Secondary	Changes in the Hospital Anxiety and Depression Scale	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.	At baseline, week 6, week 12 and month 6
Secondary	Changes in muscle biopsy of the vastus lateralis: muscle fiber typing	Changes in muscle biopsy of the vastus lateralis: muscle fiber typing	At baseline and week 12
Secondary	Changes in muscle biopsy of the vastus lateralis: muscle fiber size	Changes in muscle biopsy of the vastus lateralis: muscle fiber size (smallest diameter of the fiber)	At baseline and week 12
Secondary	Changes in muscle biopsy of the vastus lateralis: muscle proteomics	Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)	At baseline and week 12
Secondary	Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics	Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics (RNA expression analysis)	At baseline and week 12
Secondary	Changes in muscle biopsy of the vastus lateralis: mitochondrial function	Changes in muscle biopsy of the vastus lateralis: mitochondrial function. Analysis of mitochondrial markers and enzymes	At baseline and week 12
Secondary	Changes in muscle biopsy of the vastus lateralis: Nuclear foci	Changes in muscle biopsy of the vastus lateralis: Nuclear foci (changes in accumulation of nuclear foci)	At baseline and week 12
Secondary	Changes in the time to perform of the Timed Up and Go	Changes in the time to perform of the Timed Up and Go	At baseline, week 6, week 12, month 6 and month 9
Secondary	Changes in the time to perform the Timed stair test	Changes in the time to perform the Timed stair test	At baseline, week 6, week 12, month 6 and month 9
Secondary	Change in the score of the Brief Pain Inventory	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.	At baseline, week 6, week 12, month 6 and month 9
Secondary	Self-perceived changes in daily life	Self-perceived changes in daily life	At week 12
Secondary	Change in the number of falls	Number of falls in the last week and in the last month	At baseline, week 12, month 6 ans month 9
Secondary	Change in score of the DM1-Activ questionnaire	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.	At baseline, week 6, week 12, month 6 ans month 9
Secondary	Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)	Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)	At baseline and week 12
Secondary	Change in urine sample : exercise biomarkers (-Omics markers)	Change in urine sample : exercise biomarkers (-Omics markers)	At baseline and week 12
Secondary	Change in saliva sample : exercise biomarkers (-Omics markers)	Change in saliva sample : exercise biomarkers (-Omics markers)	At baseline and week 12
Secondary	Change of the center of pressure (COP) measure in static posturography : open eyes bipodal position	Change of the center of pressure (COP) in static posturography : open eyes bipodal position	At baseline, week 6, week 12, 6 months and 9 months
Secondary	Change of the center of pressure (COP) measure in static posturography : closed eyes bipodal position	Change of the center of pressure (COP) in static posturography : closed eyes bipodal position	At baseline, week 6, week 12, 6 months and 9 months
Secondary	Change of the center of pressure (COP) measure in static posturography : open eyes semi-tandem position	Change of the center of pressure (COP) in static posturography : open eyes semi-tandem position	At baseline, week 6, week 12, 6 months and 9 months
Secondary	Change of the center of pressure (COP) measure in static posturography : open eyes tandem position	Change of the center of pressure (COP) in static posturography : open eyes tandem position	At baseline, week 6, week 12, 6 months and 9 months