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Clinical Trials/NCT05081791
NCT05081791
Completed
Not Applicable

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

Universitat Pompeu Fabra1 site in 1 country38 target enrollmentSeptember 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscular Dystrophies
Sponsor
Universitat Pompeu Fabra
Enrollment
38
Locations
1
Primary Endpoint
Timed Up and Go
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2022
End Date
November 4, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raquel Sebio

Lecturer

Universitat Pompeu Fabra

Eligibility Criteria

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

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)

Study Sites (1)

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