NCT05081791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

September 22, 2021

Last Update Submit

December 3, 2024

Conditions

Muscular Dystrophies

Keywords

exercise therapymuscle strengthexercise tolerancemuscular dystrophies

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go

    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

    1 week post-intervention

Secondary Outcomes (12)

  • Short Physical Performance Battery

    1 week post-intervention

  • Upper Body Muscle Strength

    1 week post-intervention

  • Lower Body Muscle Strength

    1 week post-intervention

  • Handgrip Strength

    1 week post-intervention

  • Health-Related Quality of Life

    1 week post-intervention

  • +7 more secondary outcomes

Study Arms (2)

Exercise Training

EXPERIMENTAL

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

Behavioral: Exercise Training

Control group

NO INTERVENTION

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

Interventions

Exercise TrainingBEHAVIORAL

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

Exercise Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Muscular Dystrophies

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Post-training assessments will be conducted by a blinded assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 18, 2021

Study Start

September 12, 2022

Primary Completion

November 4, 2024

Study Completion

November 4, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

ES(1)