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Exercise Therapy for Patients with Muscle Dystrophies

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05081791
Enrollment
38
Registered
2021-10-18
Start date
2022-09-12
Completion date
2024-11-04
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Dystrophies

Keywords

exercise therapy, muscle strength, exercise tolerance, muscular dystrophies

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.

Interventions

BEHAVIORALExercise Training

12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.

Sponsors

Hospital Clinic of Barcelona
CollaboratorOTHER
Universitat Pompeu Fabra
Lead SponsorOTHER

Study design

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

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Timed Up and Go1 week post-interventionTime 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

MeasureTime frameDescription
Upper Body Muscle Strength1 week post-interventionMuscle strength of the biceps brachii will be assessed with a hand-held dynamometer
Lower Body Muscle Strength1 week post-interventionMuscle strength of the quadriceps will be assessed with a hand-held dynamometer
Handgrip Strength1 week post-interventionHandgrip strength will be assessed with a hydraulic dynamometer.
Health-Related Quality of Life1 week post-interventionHRQoL 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 Weight1 week post-interventionBody weight (kg)
Short Physical Performance Battery1 week post-interventionScore in this test is derived from three assessments: balance, gait speed and lower limb muscle performance
Percentage of fat-free mass1 week post-interventionPercentage of fat-free mass will be obtained through bio-impedance analysis
Percentage of fat mass1 week post-interventionPercentage of fat mass will be obtained through bio-impedance analysis
Fatigue1 week post-interventionFatigue 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 Strength1 week post-interventionMaximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.
Physical Activity Levels1 week post-interventionAccelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity
Body Mass Index1 week post-interventionBody weight and height will be combined to report the results on body mass index (kg/m2)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026