免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myotonic Dystrophy 1 | Other: Training program | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| Intervention Model: | Sequential Assignment |
| 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 |
| Masking: | None (Open Label) |
| Masking Description: | Most outcomes where not masked, however the outcome assessor was masked for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor did not know if it was from baseline or from after the training program. |
| Primary Purpose: | Supportive Care |
| Official Title: | Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1 |
| Actual Study Start Date : | July 1, 2017 |
| Actual Primary Completion Date : | June 22, 2018 |
| Actual Study Completion Date : | June 22, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: Training program |
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 were performed between 6 and 8 maximal repetitions.
|
Outcome Measures
Primary Outcome Measures :
- Changes in maximal isometric muscle strength of the knee extensors [ Time Frame: 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 :
- Changes in maximal isometric muscle strength of the knee flexors [ Time Frame: 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 maximal isometric muscle strength of the hip flexors [ Time Frame: 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 maximal isometric muscle strength of the hip extensors [ Time Frame: 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 [ Time Frame: 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 1-repetition maximum strength of the leg extension exercise [ Time Frame: At baseline, week 6 and week 12 ]Changes in 1-repetition maximum strength of the leg extension exercise
- Changes in 1-repetition maximum strength of the leg press exercise [ Time Frame: 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 [ Time Frame: At baseline, week 6 and week 12 ]Changes in 1-repetition maximum strength of the hip abduction exercise
- Changes in 1-repetition maximum strength of the squat exercise [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 number of repetitions in the 30-seconds sit-to-stand test [ Time Frame: 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 lower extremity functional scale [ Time Frame: 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 the score of the myotonic dystrophy health index [ Time Frame: 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 the score of the Fatigue and Daytime Sleepiness Scale [ Time Frame: 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 Marin apathy scale [ Time Frame: 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 Well-Being Manifestations Measure Scale [ Time Frame: 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 the Hospital Anxiety and Depression Scale [ Time Frame: 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 typing [ Time Frame: At baseline and week 12 ]Changes in muscle biopsy of the vastus lateralis: muscle fiber typing
- Changes in muscle biopsy of the vastus lateralis: muscle fiber size [ Time Frame: At baseline and week 12 ]Changes in muscle biopsy of the vastus lateralis: muscle fiber size (smallest diameter of the fiber)
- Changes in muscle biopsy of the vastus lateralis: muscle proteomics [ Time Frame: At baseline and week 12 ]Changes in muscle biopsy of the vastus lateralis: muscle proteomics (protein expression)
Eligibility Criteria
| Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Locations
| Canada, Quebec | |
| Groupe de recherche interdisciplinaire sur les maladies neuromusculaires | |
| Saguenay, Quebec, Canada, G7X 7X2 | |
Sponsors and Collaborators
Élise Duchesne
Fondation du Grand défi Pierre Lavoie
Investigators
| Principal Investigator: | Elise Duchesne, Ph.D. | Université du Québec à Chicoutimi |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 9, 2019 | ||||
| First Posted Date ICMJE | July 15, 2019 | ||||
| Last Update Posted Date | July 17, 2019 | ||||
| Actual Study Start Date ICMJE | July 1, 2017 | ||||
| Actual Primary Completion Date | June 22, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in maximal isometric muscle strength of the knee extensors [ Time Frame: 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
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1 | ||||
| Official Title ICMJE | Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1 | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Intervention Model: Sequential Assignment 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 Masking: None (Open Label)Masking Description: Most outcomes where not masked, however the outcome assessor was masked for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor did not know if it was from baseline or from after the training program. Primary Purpose: Supportive Care
|
||||
| Condition ICMJE | Myotonic Dystrophy 1 | ||||
| Intervention ICMJE | 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 were performed between 6 and 8 maximal repetitions.
|
||||
| Study Arms ICMJE | Experimental: Training program
Intervention: Other: Training program
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
11 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 22, 2018 | ||||
| Actual Primary Completion Date | June 22, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 30 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04018820 | ||||
| Other Study ID Numbers ICMJE | 2017-005 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Élise Duchesne, Université de Sherbrooke | ||||
| Study Sponsor ICMJE | Élise Duchesne | ||||
| Collaborators ICMJE | Fondation du Grand défi Pierre Lavoie | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Université de Sherbrooke | ||||
| Verification Date | July 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
