Muscular Dystrophy, DuchenneNCT04669847
The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in DMD
A study testing Trunk-oriented exercise program and Conventional exercise program in people with Muscular Dystrophy, Duchenne and Upper Extremity, run by Gokce Yagmur Gunes Gencer at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 16 years, men only
- Conditions the study is for
- Muscular Dystrophy, Duchenne, Upper Extremity, Respiratory Functions
- What is being tested?
- Trunk-oriented exercise program and Conventional exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2018to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in Duchenne Muscular Dystrophy
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.
Read the 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.
.
- Being tested
- Trunk-oriented exercise program, Conventional exercise program
- Keywords
- Duchenne Muscular Dystrophy, Trunk exercise, Trunk control, Upper Extremity, Respiratory functions
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk-oriented exercise programOther
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.
Conventional exercise programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients who performed Trunk-oriented exercise program and conventional exercise program Receives: Other: Trunk-oriented exercise program; Other: Conventional exercise program |
| Control Group | Experimental | Patients who performed a conventional exercise program Receives: Other: Conventional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start7 Apr 2018
- Primary completion1 Apr 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Dystrophy, DuchenneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gokce Yagmur Gunes Gencer
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Gokce Yagmur Gunes Gencer, Akdeniz University
- Investigators
- GOKCE YAGMUR GUNES GENCER, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669847
- Sponsor's protocol ID
- Trunk Training Exercise in DMD
- Status last verified
- Dec 2020
- First submitted
- 9 Jan 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT04669847
- Acronym / sponsor ID
- Trunk Training Exercise in DMD
- Keywords
- Duchenne Muscular Dystrophy, Trunk exercise, Trunk control, Upper Extremity, Respiratory functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gokce Yagmur Gunes GencerUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Trunk-oriented exercise program, Other: Conventional exercise programPatients who performed Trunk-oriented exercise program and conventional exercise program |
| Control Group | Experimental | Other: Conventional exercise programPatients who performed a conventional exercise program |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trunk-oriented exercise programThe 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 | Study Group |
| Conventional exercise programConventional 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). | Other | Control Group, Study Group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GOKCE YAGMUR GUNES GENCER principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk-oriented exercise program and Conventional exercise program in people with Muscular Dystrophy, Duchenne and Upper Extremity, run by Gokce Yagmur Gunes Gencer at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk control (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.