Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy

NCT05849688 | Unknown DMC

• 1 other identifier: P.T.REC/012/004396
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Bicycle Erogmeter; Spirometry; Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (3)

• Forced Vital Capacity (FVC)

  Spirometry will be used to measure forced vital capacity (FVC). It is the maximum volume of gas that can be expired when the child exhales as forcefully and as rapidly as possible after a maximal inspiration to assess the overall ability to move air in and out of the lungs. It is expressed in liter/minute.

  Up to 12 weeks

• Forced Expiratory Volume in the First Second (FEV1)

  Spirometry will be used to measure forced expiratory volume in the first second (FEV1). It is the volume of gas expired over a given time interval (the first second) from the beginning of the FVC maneuver that reflects airflow in the large airways. It is expressed in liter/minute.

  Up to 12 weeks

• Forced Expiratory Volume in the First Second/Forced Vital Capacity Ratio (FEV1/FVC%)

  Spirometry will be used to measure forced expiratory volume in the first second/forced vital capacity ratio (FEV1/FVC%). It is the relationship between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) to determine if the respiratory pattern is obstructive, restrictive or normal pattern. It is expressed in (%).

  Up to 12 weeks

Secondary Outcomes (1)

• Ambulatory status assessment

  Up to 12 weeks

Study Arms (2)

Designed Physical Therapy Program

ACTIVE COMPARATOR

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

Other: Designed Physical Therapy Program

Bicycle Ergometry Training

EXPERIMENTAL

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

Other: Bicycle Ergometry Training

Interventions

Designed Physical Therapy Program 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.

Designed Physical Therapy Program

Bicycle Ergometry Training 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

Bicycle Ergometry Training

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Eman Wagdy, PH.D

CONTACT

01008079576; Eman.wagdy@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Physical Therapy and Bicycle Ergometry

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 9, 2023
• Study Start: May 15, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04