Exercise Therapy for Patients With Muscle Dystrophies

Study Overview
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Brief Summary
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Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.

Official Title
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Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients With Muscle Dystrophies

Conditions
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Muscular Dystrophies

Intervention / Treatment
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* Behavioral: Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy. Age > 18 years old Ability to walk independently for 10 or more metres Exclusion Criteria: Inability to understand or read Spanish/Catalan. Patients engaging in a similar exercise-based program in the past 12 months Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program Unstable respiratory, cardiovascular or metabolic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br>This group will engage in a 12-week exercise training program | Behavioral: Exercise Training<br>* 12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.<br>|
| No Intervention: Control group<br>Usual care. Patients in this group will be offered the same program at the end of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go | Time consumed by the patient to raise from a chair, walk 3 meters, turn 180º, walk 3 metres back and sit down on the chair | 1 week post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery | Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance | 1 week post-intervention | 
| Upper Body Muscle Strength | Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer | 1 week post-intervention | 
| Lower Body Muscle Strength | Muscle strength of the quadriceps will be assessed with a hand-held dynamometer | 1 week post-intervention | 
| Handgrip Strength | Handgrip strength will be assessed with a hydraulic dynamometer. | 1 week post-intervention | 
| Health-Related Quality of Life | HRQoL will be measured with the Short-Form Health Survey (SF-12). The score of the scale goes from 0 - 100, with higher scores representing better health-related quality of life. | 1 week post-intervention | 
| Body Weight | Body weight (kg) | 1 week post-intervention | 
| Body Mass Index | Body weight and height will be combined to report the results on body mass index (kg/m2) | 1 week post-intervention | 
| Percentage of fat-free mass | Percentage of fat-free mass will be obtained through bio-impedance analysis | 1 week post-intervention | 
| Percentage of fat mass | Percentage of fat mass will be obtained through bio-impedance analysis | 1 week post-intervention | 
| Fatigue | Fatigue will be quantified with the Brief Fatigue Inventory. The scale has 9 items with a maximal score of 10 points. Higher scores represent heavier fatigue. | 1 week post-intervention | 
| Respiratory Muscle Strength | Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM. | 1 week post-intervention | 
| Physical Activity Levels | Accelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity | 1 week post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise therapy, muscle strength, exercise tolerance, muscular dystrophies