Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients with Muscle Dystrophies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universitat Pompeu Fabra
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Timed Up and Go
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Post-training assessments will be conducted by a blinded assessor
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
Usual care. Patients in this group will be offered the same program at the end of the study
Exercise Training
This group will engage in a 12-week exercise training program
Intervention: Exercise Training (Behavioral)
Outcomes
Primary Outcomes
Timed Up and Go
Time Frame: 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 Outcomes
- Body Mass Index(1 week post-intervention)
- Fatigue(1 week post-intervention)
- Respiratory Muscle Strength(1 week post-intervention)
- Short Physical Performance Battery(1 week post-intervention)
- Upper Body Muscle Strength(1 week post-intervention)
- Handgrip Strength(1 week post-intervention)
- Health-Related Quality of Life(1 week post-intervention)
- Body Weight(1 week post-intervention)
- Percentage of fat-free mass(1 week post-intervention)
- Physical Activity Levels(1 week post-intervention)
- Lower Body Muscle Strength(1 week post-intervention)
- Percentage of fat mass(1 week post-intervention)
Investigators
Raquel Sebio
Lecturer
Universitat Pompeu Fabra