Exercise Therapy for Patients with Muscle Dystrophies
- Conditions
- Muscular Dystrophies
- Interventions
- Behavioral: Exercise Training
- Registration Number
- NCT05081791
- Lead Sponsor
- Universitat Pompeu Fabra
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Training Exercise Training This group will engage in a 12-week exercise training program
- Primary Outcome Measures
Name Time Method Timed Up and Go 1 week post-intervention 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
- Secondary Outcome Measures
Name Time Method Body Mass Index 1 week post-intervention Body weight and height will be combined to report the results on body mass index (kg/m2)
Fatigue 1 week post-intervention 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.
Respiratory Muscle Strength 1 week post-intervention Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.
Short Physical Performance Battery 1 week post-intervention Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance
Upper Body Muscle Strength 1 week post-intervention Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer
Handgrip Strength 1 week post-intervention Handgrip strength will be assessed with a hydraulic dynamometer.
Health-Related Quality of Life 1 week post-intervention 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.
Body Weight 1 week post-intervention Body weight (kg)
Percentage of fat-free mass 1 week post-intervention Percentage of fat-free mass will be obtained through bio-impedance analysis
Physical Activity Levels 1 week post-intervention Accelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity
Lower Body Muscle Strength 1 week post-intervention Muscle strength of the quadriceps will be assessed with a hand-held dynamometer
Percentage of fat mass 1 week post-intervention Percentage of fat mass will be obtained through bio-impedance analysis
Trial Locations
- Locations (1)
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain