Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy

NCT ID: NCT05849688

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-08-15

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.

Conditions

Duchenne Muscular Dystrophy

Study Design

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

Study Groups

Designed Physical Therapy Program

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

Group Type: ACTIVE_COMPARATOR

Designed Physical Therapy Program

Intervention Type: OTHER

The designed physical therapy program include gentle stretching exercises for biceps brachii, hamstrings and calf muscles bilaterally (5 times for every muscle) and isometric muscle contraction for quadriceps, hamstrings, anterior tibial group, calf muscles, biceps and triceps muscles (5 times for every muscle). Also, diaphragmatic breathing exercises will be applied.

Bicycle Ergometry Training

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

Group Type: EXPERIMENTAL

Bicycle Ergometry Training

Intervention Type: OTHER

The designed physical therapy program include gentle stretching exercises for biceps brachii, hamstrings and calf muscles bilaterally (5 times for every muscle) and isometric muscle contraction for quadriceps, hamstrings, anterior tibial group, calf muscles, biceps and triceps muscles (5 times for every muscle). Also, diaphragmatic breathing exercises will be applied + bicycle ergometry training

Interventions

Designed Physical Therapy Program

The designed physical therapy program include gentle stretching exercises for biceps brachii, hamstrings and calf muscles bilaterally (5 times for every muscle) and isometric muscle contraction for quadriceps, hamstrings, anterior tibial group, calf muscles, biceps and triceps muscles (5 times for every muscle). Also, diaphragmatic breathing exercises will be applied.

Intervention Type: OTHER

Bicycle Ergometry Training

The designed physical therapy program include gentle stretching exercises for biceps brachii, hamstrings and calf muscles bilaterally (5 times for every muscle) and isometric muscle contraction for quadriceps, hamstrings, anterior tibial group, calf muscles, biceps and triceps muscles (5 times for every muscle). Also, diaphragmatic breathing exercises will be applied + bicycle ergometry training

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Eman Wagdy

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eman Wagdy, PH.D

Role: CONTACT

Eman.wagdy@pt.bsu.edu.eg

01008079576

Other Identifiers

P.T.REC/012/004396

Identifier Type: -

Identifier Source: org_study_id