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

NCT04669847 | Completed

• 1 other identifier: Trunk Training Exercise in DMD
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Dystrophy, Duchenne; Upper Extremity; Respiratory Functions

Keywords

Duchenne Muscular Dystrophy; Trunk exercise; Trunk control; Upper Extremity; Respiratory functions

Outcome Measures

Primary Outcomes (5)

• 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.

  8 weeks

• 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.

  8 weeks.

• 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.

  8 weeks.

• 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.

  8 weeks.

• 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.

  8 weeks.

Study Arms (2)

Study Group

EXPERIMENTAL

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

Other: Trunk-oriented exercise program; Other: Conventional exercise program

Control Group

EXPERIMENTAL

Patients who performed a conventional exercise program

Other: Conventional exercise program

Interventions

Trunk-oriented exercise program OTHER

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.

Study Group

Conventional exercise program OTHER

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).

Control Group; Study Group

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Gokce Yagmur Gunes Gencer: lead
• Hacettepe University: collaborator

Study Sites (1)

Gokce Yagmur Gunes Gencer

Antalya, 07070, Turkey (Türkiye)

Location

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

Study Officials

• GOKCE YAGMUR GUNES GENCER

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: December 17, 2020
• Study Start: April 7, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 6, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)