Quality of LifeNCT05501457
The Effect of Different Muscle Training on Activities of Daily Living in COPD
A study testing Muscle strengthening with neuromuscular electrical stimulation in people with Quality of Life and Anxiety, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Anxiety
- What is being tested?
- Muscle strengthening with neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 1 Nov 2022
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 18-75 years old,
- Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,
- PaO2 >55 mm Hg, PaCO2 <45 mmHg in room air.
Who cannot join
- Exacerbation,
- Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),
- Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),
- Musculoskeletal disorder (conditions affecting exercise ability),
- Difficulty communicating.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hititi University Sungurlu Vocational School
Çorum, 19000
Ahmet Payas, 05343483399, ahmetpayas@hitit.edu.tr
About this study
Official title: Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD
Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity. Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD). Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.
- Conditions
- Quality of Life, Anxiety
- Being tested
- Muscle strengthening with neuromuscular electrical stimulation
- Keywords
- COPD, Pulmonary rehabilitation, Neuromuscular electrical stimulation
- Medical subject headings
- Anxiety Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strengthening with neuromuscular electrical stimulationDevice
The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
| Study group | Role | What they receive |
|---|---|---|
| The gastrocnemius group | Experimental | The patients in the first group (n=15) were given a pulmonary rehabilitation program and additionally 20 minutes of Neuromuscular electrical stimulation (Group 1) to the gastrocnemius muscle, Receives: Device: Muscle strengthening with neuromuscular electrical stimulation |
| The quadriceps femoris group | Experimental | The second group was given a pulmonary rehabilitation program and an additionally 20 minutes of neuromuscular electrical stimulation to the quadriceps femoris muscle (Group 2), Receives: Device: Muscle strengthening with neuromuscular electrical stimulation |
| The control group | Experimental | The third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3). Receives: Device: Muscle strengthening with neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test (6 MWT):
they could walk for 6 minutes, according to heart rate, blood pressure, respiratory rate, finger oxygen saturation, the walking distance at the end of walking, and dyspnea score according to the Modified Borg Scale (MBS) at the beginning and end of walking was recorded. Change from baseline 6 Minute walking performance after 4 weeks will be examined.
Measured: 4 weeks
Secondary outcomes (3)
Modified Borg Scale (MBS):
It consists of 10 items that define the severity of dyspnea according to their degrees. Change from baseline dyspnea after 4 weeks will be examined.
Measured: 4 weeks
St. George's Respiratory Questionnaire (SGRQ):
This questionnaire was developed specifically to determine the severity of the disease in COPD and asthma. Change from baseline severity of the disease after 4 weeks will be examined.
Measured: 4 weeks
Beck Depression Inventory (BDI):
It measures the behavioral findings of depression in adolescents and adults. Change from baseline depression status after 4 weeks will be examined.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start15 Jul 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Payas, Hitit University
- Investigators
- Ahmet Payas, Dr, Study director, HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501457
- Sponsor's protocol ID
- HititUApayas
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A short summary of the study can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD
- ClinicalTrials.gov ID
- NCT05501457
- Acronym / sponsor ID
- HititUApayas
- Conditions
- Quality of Life, Anxiety
- Keywords
- COPD, Pulmonary rehabilitation, Neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 15 Aug 2022 (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.
Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity. Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD). Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The gastrocnemius group | Experimental | Device: Muscle strengthening with neuromuscular electrical stimulationThe patients in the first group (n=15) were given a pulmonary rehabilitation program and additionally 20 minutes of Neuromuscular electrical stimulation (Group 1) to the gastrocnemius muscle, |
| The quadriceps femoris group | Experimental | Device: Muscle strengthening with neuromuscular electrical stimulationThe second group was given a pulmonary rehabilitation program and an additionally 20 minutes of neuromuscular electrical stimulation to the quadriceps femoris muscle (Group 2), |
| The control group | Experimental | Device: Muscle strengthening with neuromuscular electrical stimulationThe third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between 18-75 years old,
- Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,
- PaO2 >55 mm Hg, PaCO2 <45 mmHg in room air.
Key exclusion criteria (5 listed)
- Exacerbation,
- Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),
- Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),
- Musculoskeletal disorder (conditions affecting exercise ability),
- Difficulty communicating.
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 |
|---|---|---|
| Muscle strengthening with neuromuscular electrical stimulationThe effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined. | Device | The control group, The gastrocnemius group, The quadriceps femoris group |
Primary outcome
6 Minute Walk Test (6 MWT):
Time frame: 4 weeks
they could walk for 6 minutes, according to heart rate, blood pressure, respiratory rate, finger oxygen saturation, the walking distance at the end of walking, and dyspnea score according to the Modified Borg Scale (MBS) at the beginning and end of walking was recorded. Change from baseline 6 Minute walking performance after 4 weeks will be examined.
3 secondary outcomes
Modified Borg Scale (MBS):
Time frame: 4 weeks
St. George's Respiratory Questionnaire (SGRQ):
Time frame: 4 weeks
Beck Depression Inventory (BDI):
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No. A short summary of the study can be shared.
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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.
Ahmet Payas, Dr study director
HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle strengthening with neuromuscular electrical stimulation in people with Quality of Life and Anxiety, run by Hitit University 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 5 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: status not confirmed, as of the sponsor's last update on 15 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Payas, Dr (05343483399, ahmetpayas@hitit.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6 MWT): (time frame: 4 weeks). 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 15 Aug 2022.