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Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy

Primary Purpose

Duchenne Muscular Dystrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Designed Physical Therapy Program
Bicycle Ergometry Training
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duchenne Muscular Dystrophy focused on measuring Bicycle Erogmeter, Spirometry, Duchenne Muscular Dystrophy

Eligibility Criteria

8 Years - 10 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Designed Physical Therapy Program

    Bicycle Ergometry Training

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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 (%).

    Secondary Outcome Measures

    Ambulatory status assessment
    The North Star Ambulatory Assessment (NSAA) will be used to to evaluate the ambulatory status of each boy. It is a 17-item scale (Standing-Walk-Stand up from chair-Stand on one leg Right & Left-Climb box step Right & Left-Descend box step Right & Left-Lifts head from supine-Gets to sitting-Rise from floor-Stands on heels-Jump-Hop Right & Left leg-Run 10-meters) that grades performance of various functional skills on a scale from 0 (unable), 1 (completes independently but with modifications), and 2 (completed without compensation).

    Full Information

    First Posted
    April 25, 2023
    Last Updated
    May 5, 2023
    Sponsor
    Beni-Suef University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05849688
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2023 (Anticipated)
    Study Completion Date
    August 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beni-Suef University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Duchenne Muscular Dystrophy
    Keywords
    Bicycle Erogmeter, Spirometry, Duchenne Muscular Dystrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Physical Therapy and Bicycle Ergometry
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Designed Physical Therapy Program
    Arm Type
    Active Comparator
    Arm Description
    Boys with Duchenne muscular dystrophy will receive the designed physical therapy program for 1 hour/ session.
    Arm Title
    Bicycle Ergometry Training
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    Designed Physical Therapy Program
    Intervention Description
    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
    Intervention Name(s)
    Bicycle Ergometry Training
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Forced Vital Capacity (FVC)
    Description
    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.
    Time Frame
    Up to 12 weeks
    Title
    Forced Expiratory Volume in the First Second (FEV1)
    Description
    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.
    Time Frame
    Up to 12 weeks
    Title
    Forced Expiratory Volume in the First Second/Forced Vital Capacity Ratio (FEV1/FVC%)
    Description
    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 (%).
    Time Frame
    Up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Ambulatory status assessment
    Description
    The North Star Ambulatory Assessment (NSAA) will be used to to evaluate the ambulatory status of each boy. It is a 17-item scale (Standing-Walk-Stand up from chair-Stand on one leg Right & Left-Climb box step Right & Left-Descend box step Right & Left-Lifts head from supine-Gets to sitting-Rise from floor-Stands on heels-Jump-Hop Right & Left leg-Run 10-meters) that grades performance of various functional skills on a scale from 0 (unable), 1 (completes independently but with modifications), and 2 (completed without compensation).
    Time Frame
    Up to 12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Ccongenital or acquired skeletal deformities or cardiopulmonary dysfunction. Previous orthopaedic surgery in lower limbs. Behavioral problems causing inability to cooperate during the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Wagdy, PH.D
    Phone
    01008079576
    Email
    Eman.wagdy@pt.bsu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy

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