Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy

Beni-Suef University

Status: Not yet enrolling

Conditions: Duchenne Muscular Dystrophy

Treatments: Other: Bicycle Ergometry Training; Other: Designed Physical Therapy Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05849688

P.T.REC/012/004396

Details and patient eligibility

About

The purpose of the study is to investigate the effect of bicycle ergometry training on ventilatory functions in boys with Duchenne muscular dystrophy.

Full description

Duchenne muscular dystrophy (DMD) is a common genetic X chromosome-linked recessive muscular dystrophy. It causes deterioration in mobility, progressive deformities in musculoskeletal system, upper limb impairment, and impaired airway clearance. Deterioration in respiratory muscles is the major cause of mortality and morbidity in DMD in their second to the third decade as a secondary complication in respiratory and cardiovascular systems. Cycling exercise is an easy functional treatment that considered as an aerobic exercise used to improve ventilatory functions, strength of respiratory muscles and therefore prevents respiratory diseases. Several studies support the benefit of bicycle ergometry training on ventilatory functions in different diseases while, there is no research conducted its effect on Duchenne muscular dystrophy. Hence, there is need to study the effect of bicycle ergometry training on ventilatory functions in Duchenne muscular dystrophy.

Thirty boys with Duchenne muscular dystrophy aged from 8-10 years will be recruited from Abu El-Rish Pediatric Hospital. They will be divided randomly into control group (15 boys) and study group (15 boys). Control group will be participated in designed physical therapy program. Study group will be trained on the bicycle ergometer in addition to the same designed physical therapy program participated in control group.

Enrollment: 30 estimated patients

Sex: Male

Ages: 8 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Boys ages will be ranged from 8 to 10 years old.
2. Confirmed diagnosis as Duchenne muscular dystrophy.
3. Lower limb functional levels ranged from Grades 1 through 3 acc. to Vignos scale for lower extremities.
4. Still ambulant and able to sit independently for at least 1 hour.

Exclusion criteria

1. Ccongenital or acquired skeletal deformities or cardiopulmonary dysfunction.
2. Previous orthopaedic surgery in lower limbs.
3. Behavioral problems causing inability to cooperate during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Designed Physical Therapy Program

Active Comparator group

Description:

Boys with Duchenne muscular dystrophy will receive the designed physical therapy program for 1 hour/ session.

Treatment:

Other: Designed Physical Therapy Program

Bicycle Ergometry Training

Experimental group

Description:

Boys with Duchenne muscular dystrophy will receive the designed physical therapy program for 1 hour/ session in addition to bicycle ergometry training for 20 min./ session

Treatment:

Other: Bicycle Ergometry Training