Bicycle Ergometer Training in Duchenne Muscular Dystrophy

NCT ID: NCT05330195

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-05-25

Brief Summary

The progressive muscle weakness and contractures of the patients adversely affect their gait and balance. It is known that the disorder of the patients' balance and gait affects their functional capacity. The aim of this study is to examine the effects of bicycle ergometer training on gait and balance in children with Duchenne Muscular Dystrophy. Twenty-four children with DMD included in the study will be divided into two groups as home program and home program+bicycle ergometer training with block randomization method. Home program including stretching, respiratory, range of motion, posture 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 40 minutes total duration consisting of 5 min warm up and 5 min cool down period. Gait and balance were evaluated with GAITrite and Bertec Balance Check Screener, successively. Assessments will be applied at pre-training and after 12 weeks of training.

Conditions

Duchenne Muscular Dystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group

Group Type: EXPERIMENTAL

Bicycle Ergometer Training

Intervention Type: OTHER

Bicycle ergometer training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group.

Home-based exercise group

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 Based Exercise Group 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 3-5 days a week.

Group Type: ACTIVE_COMPARATOR

Home-based exercise group

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

Bicycle Ergometer Training

Bicycle ergometer training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period to children in treatment group.

Intervention Type: OTHER

Home-based exercise group

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

Inclusion Criteria

• Children have diagnosis of DMD confirmed by genetic analysis,
• Children can walk with unsupported.

Exclusion Criteria

• Children have undergone any surgery or suffered injury of the lower limbs,
• Children have severe contractures of lower limbs,
• Children have low cooperation
• Children have comorbid disease,
• Children were applied regular aerobic training such as bicycle training and hydrotherapy in last 6 months.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Numan Bulut

Research Assistant (Assistant of neuromuscular disorders unit)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022008

Identifier Type: -

Identifier Source: org_study_id