Aerobic Exercise in Duchenne Muscular Dystrophy

NCT ID: NCT04173234

Last Updated: 2021-09-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-11

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with an estimate incidence of 1 in 3500 to 5000 male births. The effect of aerobic training on muscle architectural properties and motor functions such as muscle activation is not clear in DMD. The aim of this study is to investigate the effects of aerobic training on these parameters in children with DMD. Twenty children with DMD included in the study will be divided into two groups as home program and home program+aerobic training with block randomization method. Home program including stretching, respiratory, range of motion and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period. Muscle architectural properties, muscle strength, muscle activation and motor function will be assessed with ultrasonographic, hand-held myometry, surface EMG and Motor Function Measure, consecutively. Assessments will be applied at pre-training and after 12 weeks of training.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Duchenne Muscular Dystrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week. Also, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.

Group Type EXPERIMENTAL

Aerobic Training

Intervention Type OTHER

Aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.

Home exercise program

Intervention Type OTHER

Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.

Control Group

Home exercise program Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do this program for 5 days a week.

Group Type ACTIVE_COMPARATOR

Home exercise program

Intervention Type OTHER

Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aerobic Training

Aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.

Intervention Type OTHER

Home exercise program

Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children had diagnosis of DMD confirmed by genetic analysis,
* Children had functional level of Grade 1 and 2 according to Vignos Scale.

Exclusion Criteria

* Children had undergone any surgery or suffered injury of the lower limbs,
* Children had comorbid disease
* Children were applied regular aerobic training in last 6 months.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Numan Bulut

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KA-19022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.