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Exercise Therapy for Patients with Muscle Dystrophies

NCT ID: NCT05081791

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2024-11-04

Brief Summary

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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

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Conditions

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Muscular Dystrophies

Keywords

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exercise therapy muscle strength exercise tolerance muscular dystrophies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Post-training assessments will be conducted by a blinded assessor

Study Groups

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Exercise Training

This group will engage in a 12-week exercise training program

Group Type EXPERIMENTAL

Exercise Training

Intervention Type BEHAVIORAL

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

Control group

Usual care. Patients in this group will be offered the same program at the end of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role lead

Responsible Party

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Raquel Sebio

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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HCLINIC - MD - 2021

Identifier Type: -

Identifier Source: org_study_id