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NCT Number: NCT05081791

Exercise Therapy for Patients with Muscle Dystrophies

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.

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Key information

Conditions

Muscular Dystrophies Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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

Primary outcomes

  1. 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

  1. Short Physical Performance Battery

    Time frame: 1 week post-intervention

    Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance

  2. Upper Body Muscle Strength

    Time frame: 1 week post-intervention

    Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer

  3. Lower Body Muscle Strength

    Time frame: 1 week post-intervention

    Muscle strength of the quadriceps will be assessed with a hand-held dynamometer

  4. Handgrip Strength

    Time frame: 1 week post-intervention

    Handgrip strength will be assessed with a hydraulic dynamometer.

  5. Health-Related Quality of Life

    Time frame: 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.

  6. Body Weight

    Time frame: 1 week post-intervention

    Body weight (kg)

  7. Body Mass Index

    Time frame: 1 week post-intervention

    Body weight and height will be combined to report the results on body mass index (kg/m2)

  8. Percentage of fat-free mass

    Time frame: 1 week post-intervention

    Percentage of fat-free mass will be obtained through bio-impedance analysis

  9. Percentage of fat mass

    Time frame: 1 week post-intervention

    Percentage of fat mass will be obtained through bio-impedance analysis

  10. Fatigue

    Time frame: 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.

  11. Respiratory Muscle Strength

    Time frame: 1 week post-intervention

    Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.

  12. Physical Activity Levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitat Pompeu Fabra

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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