Clinical trial NCT05849688: Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy
Official title: Ventilatory Functions Response to Bicycle Ergometry Training in Boys With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: Bicycle Erogmeter
Spirometry
Duchenne Muscular Dystrophy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 30
Sex: MALE
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Physical Therapy and Bicycle Ergometry
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Up to 12 weeks
measure: Forced Expiratory Volume in the First Second (FEV1)
timeFrame: Up to 12 weeks
measure: Forced Expiratory Volume in the First Second/Forced Vital Capacity Ratio (FEV1/FVC%)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Ambulatory status assessment
timeFrame: Up to 12 weeks
Other outcomes:
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