Bicycle Ergometer Training in Duchenne Muscular Dystrophy (BETDMD)

Hacettepe University

Status: Completed

Conditions: Duchenne Muscular Dystrophy

Treatments: Other: Home-based exercise group; Other: Bicycle Ergometer Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05330195

2022008

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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

Treatment:

Other: Bicycle Ergometer Training

Other: Home-based exercise group

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Home-based exercise group