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The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in DMD

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ClinicalTrials.gov Identifier: NCT04669847
Recruitment Status : Completed
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Gokce Yagmur Gunes Gencer, Akdeniz University

Brief Summary:

The aim of this study was to investigate the effects of trunk training on trunk control, upper extremity, and pulmonary function in children with Duchenne muscular dystrophy (DMD).

26 children with DMD aged 5-16 were included in the study. They were divided into two groups (study and control). The study group exercised with the trunk-oriented exercise program and the conventional exercise program under the supervision of a physiotherapist, whereas the control group underwent the conventional exercise program under the supervision of their families at home for 8 weeks.

Trunk control, the upper extremity function and respiratory function test were assessed before and after the 8-week exercise program in this study.


Condition or disease Intervention/treatment Phase
Muscular Dystrophy, Duchenne Upper Extremity Respiratory Functions Other: Trunk-oriented exercise program Other: Conventional exercise program Not Applicable

Detailed Description:

This study aimed to investigate the effects of trunk training on trunk control, upper extremity, and pulmonary function in children with Duchenne muscular dystrophy.

26 children with DMD aged 5-16 were included in the study. They were divided into two groups (study and control). The study group (N=13) exercised with the trunk-oriented exercise program and the conventional exercise program under the supervision of a physiotherapist, whereas the control group (N=13) underwent the conventional exercise program under the supervision of their families at home for 8 weeks. The conventional program exercises were taught to patients and their families in the study and control groups. These exercises were performed daily for 8 weeks, twice a day, on average 45 minutes, each exercise 5-10 repetitions. The conventional exercises program formed stretching exercises, and active or active-assisted strength exercises (upper extremity, lower extremity, abdominal muscles, back muscles), and the Trunk-oriented exercises were specially adapted to the patient based on the patient's functional status and active participation in the exercises. Trunk control was assessed using the Trunk Control Measurement Scale, the upper extremity function was assessed using Performance of Upper Limb and respiratory function using the pulmonary function test before and after the 8-week exercise program in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in Duchenne Muscular Dystrophy
Actual Study Start Date : April 7, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : December 6, 2019


Arm Intervention/treatment
Experimental: Study Group
Patients who performed Trunk-oriented exercise program and conventional exercise program
Other: Trunk-oriented exercise program
The trunk-oriented exercise program was performed by a physiotherapist two days of the week for 8 weeks.Trunk-oriented exercises were specially adapted to the patient based on the patient's functional status and active participation in the exercises.

Other: Conventional exercise program
Conventional exercise program was performed daily for 8 weeks, twice a day, on average 45 minutes, each exercise 5-10 repetitions. The program formed stretching exercises, and active or active-assisted strength exercises (upper extremity, lower extremity, abdominal muscles, back muscles).

Experimental: Control Group
Patients who performed a conventional exercise program
Other: Conventional exercise program
Conventional exercise program was performed daily for 8 weeks, twice a day, on average 45 minutes, each exercise 5-10 repetitions. The program formed stretching exercises, and active or active-assisted strength exercises (upper extremity, lower extremity, abdominal muscles, back muscles).




Primary Outcome Measures :
  1. Trunk control [ Time Frame: 8 weeks ]
    The trunk control levels of the children were determined according to the Trunk Control Measurement Scale (TCMS). TCMS consists of two sections: static sitting balance and dynamic sitting balance. Dynamic sitting balance is also divided into two subscales: selective movement control and dynamic reaching. The whole scale includes 15 items and all items are scored on a two-, three- or four-point ordinal scale. The total score of the TCMS ranges from 0 to 58, a higher score indicating a better performance of trunk control. TCMS is found to be a reliable and valid assessment to measure trunk control in boys with DMD.

  2. Upper extremity function [ Time Frame: 8 weeks. ]
    Upper Limb Performance was evaluated with The Performance of Upper Limb (PUL) scale. PUL consists of 22 items in total, the items that evaluate upper extremity function at the distal (hand-wrist), middle (elbow), and shoulder levels, and the first item of the scale to evaluate the general upper extremity level. Score options are range from 0-1 to 0-6 depending on the performance of the first item. Each level is evaluated separately, with a maximum score of 16 from the shoulder level, 34 from the middle level, and 24 from the distal level, and a total score of 0-74.

  3. Respiratory function (FEV1) [ Time Frame: 8 weeks. ]
    Respiratory functions were evaluated by pulmonary function tests. Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Cosmed Pony FX machine). Percentages of forced expiratory volume in one second (FEV1) value relative to the expected value was recorded in pulmonary function test.

  4. Respiratory function (FVC) [ Time Frame: 8 weeks. ]
    Respiratory functions were evaluated by pulmonary function tests. Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Cosmed Pony FX machine). Percentages of forced vital capacity (FVC) value relative to the expected value was recorded in pulmonary function test.

  5. Respiratory function (PEF) [ Time Frame: 8 weeks. ]
    Respiratory functions were evaluated by pulmonary function tests. Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Cosmed Pony FX machine). Percentages of peak flow rate (PEF) value relative to the expected value was recorded in pulmonary function test.



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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Duchenne Muscle Dystrophy
  • No injuries and no neurological or orthopedic surgery in the last 6 months
  • No other systemic or orthopedic / neurological disorders to prevent exercise

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669847


Locations
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Turkey
Gokce Yagmur Gunes Gencer
Antalya, Turkey, 07070
Sponsors and Collaborators
Gokce Yagmur Gunes Gencer
Hacettepe University
Investigators
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Principal Investigator: GOKCE YAGMUR GUNES GENCER Akdeniz University
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Responsible Party: Gokce Yagmur Gunes Gencer, Assistant Professor, Akdeniz University
ClinicalTrials.gov Identifier: NCT04669847    
Other Study ID Numbers: Trunk Training Exercise in DMD
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gokce Yagmur Gunes Gencer, Akdeniz University:
Duchenne Muscular Dystrophy
Trunk exercise
Trunk control
Upper Extremity
Respiratory functions
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked