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

Primary Purpose

Muscular Dystrophy, Duchenne, Upper Extremity, Respiratory Functions

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Trunk-oriented exercise program
Conventional exercise program
Sponsored by
Gokce Yagmur Gunes Gencer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophy, Duchenne focused on measuring Duchenne Muscular Dystrophy, Trunk exercise, Trunk control, Upper Extremity, Respiratory functions

Eligibility Criteria

5 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Gokce Yagmur Gunes Gencer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study Group

Control Group

Arm Description

Patients who performed Trunk-oriented exercise program and conventional exercise program

Patients who performed a conventional exercise program

Outcomes

Primary Outcome Measures

Trunk control
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.
Upper extremity function
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.
Respiratory function (FEV1)
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.
Respiratory function (FVC)
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.
Respiratory function (PEF)
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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2020
Last Updated
December 15, 2020
Sponsor
Gokce Yagmur Gunes Gencer
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04669847
Brief Title
The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in DMD
Official Title
The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in Duchenne Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gokce Yagmur Gunes Gencer
Collaborators
Hacettepe University

4. Oversight

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

5. Study Description

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.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophy, Duchenne, Upper Extremity, Respiratory Functions
Keywords
Duchenne Muscular Dystrophy, Trunk exercise, Trunk control, Upper Extremity, Respiratory functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patients who performed Trunk-oriented exercise program and conventional exercise program
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Patients who performed a conventional exercise program
Intervention Type
Other
Intervention Name(s)
Trunk-oriented exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional exercise program
Intervention Description
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 Measure Information:
Title
Trunk control
Description
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.
Time Frame
8 weeks
Title
Upper extremity function
Description
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.
Time Frame
8 weeks.
Title
Respiratory function (FEV1)
Description
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.
Time Frame
8 weeks.
Title
Respiratory function (FVC)
Description
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.
Time Frame
8 weeks.
Title
Respiratory function (PEF)
Description
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.
Time Frame
8 weeks.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GOKCE YAGMUR GUNES GENCER
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gokce Yagmur Gunes Gencer
City
Antalya
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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