Acute Exacerbation of COPDNCT05563493
Effects of Chair-Based Exercise Training on Exercise Capacity in Patients With Acute Exacerbation of COPD
A study testing Treatment group, Chair-Based Exercise Training in people with Acute Exacerbation of COPD, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Chronic obstructive pulmonary disease (COPD) is the leading cause of morbidity and mortality worldwide, a respiratory disease characterized by chronic airflow limitation that is not completely reversible. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Treatment group, Chair-Based Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2022to 30 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were hospitalized due to acute exacerbation of COPD
Who cannot join
- Patients with orthopedic or neurological problems that may interfere with assessment and education,
- Uncooperative patients,
- Patients with advanced heart problems such as acute coronary syndrome, stable angina pectoris, severe arrhythmias (Atrial fibrillation etc.), decompensated heart failure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Nezahat Keleşoğlu Faculty of Health Sciences
Konya, 42090
About this study
Official title: Comparison of the Effects of Chair-Based Exercise Training on Respiratory Functions, Exercise Capacity and Quality of Life in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is the leading cause of morbidity and mortality worldwide, a respiratory disease characterized by chronic airflow limitation that is not completely reversible.
Impaired pulmonary functions, decreased exercise capacity and quality of life and increased dyspnea perception is prevalent in patients with acute exacerbations of COPD.It was demonstrated exercise training has beneficial effects in patients with acute exacerbations of COPD.
The purpose of this study to evaluate the effects of chair-based exercise training on exercise capacity, respiratory functions, dyspnea, balance, depression anxiety and quality of life in COPD patients in acute exacerbation.
Read the detailed description
Acute exacerbations of COPD are generally defined as events in the natural course of the disease characterized by a change in the patient's initial dyspnea, cough or sputum beyond normal daily variations. The main consequences of COPD in acute exacerbation are increased mortality, deterioration in health-related quality of life, faster decline in lung function, marked reduction in physical activity and worsening of peripheral muscle weakness, which have a direct impact on patients' health. Although exacerbations are diagnosed based on respiratory symptoms, there is evidence that they have systemic consequences, including a detrimental effect on skeletal muscle function, exercise tolerance and quality of life.
Chair-based exercise training is defined as a structured and progressive exercise program applied by trainers that provides stability using a chair, which is a part of exercise training for the elderly. It is thought that it would be beneficial to study such an exercise program, since COPD patients in acute exacerbation have less mobilization during hospitalization.
In a limited number of studies, some inconsistencies were observed in the exercises of patients with acute exacerbation of COPD. Studies can therefore now focus on investigating comparisons between different intervention lengths, session durations and frequencies, and intensities of exercise training. For this reason, in our planned study, we will investigate the effects of chair-based exercise training in COPD patients in acute exacerbation. There is no study in the literature investigating the effects of chair-based exercise training in COPD patients in acute exacerbation. For this reason, our study will provide important information support to the literature.
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Treatment group, Chair-Based Exercise Training, Control group, Breathing exercise
- Keywords
- Chair-based exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment group, Chair-Based Exercise TrainingOther
The weights of the elastic bands to be used in the exercises will be determined by the physiotherapist according to the abilities and development of the participants.
The intensity of the exercise will be adjusted according to the dyspnea or fatigue patients feel according to the Modified Borg Scale.
During the exercises, heart rate and oxygen saturation will be measured with a pulse oximeter, and blood pressure will be measured with a sphygmomanometer.
Chair-based exercise training will be applied to the patients every day they are hospitalized.
Control group, Breathing exerciseOther
Breathing exercise will be applied to the patients every day they are hospitalized.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group, Chair-Based Exercise Training | Experimental | Treatment group will receive chair-based exercise training. Chair-based exercise training consisting of 20 different exercises will be applied in 2-3 sets with an average of 8-15 repetitions. Rest between sets will average 45-60 seconds. Receives: Other: Treatment group, Chair-Based Exercise Training |
| Control group, Breathing exercise | Other | Control group will receive breathing exercises. Receives: Other: Control group, Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Exercise Capacity
Functional exercise capacity will be evaluated with 6-minute walk test.
Measured: Seven day
Pulmonary Function Test
This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values.
Measured: Seven day
Secondary outcomes (5)
Dyspnea
The severity of dyspnea during daily living activities is evaluated using the Modified Medical Research Council (MMRC) dyspnea scale.
Measured: Seven day
One Minute Sit to Stand Test
The number of completed sit to stand repetitions in 1 minute. Patients stand/sit from a chair as many times as they can in one minute.
Measured: Seven day
Timed Up and Go Test
The Timed Up and Go test is evaluated dynamic balance.
Measured: Seven day
Depression and Anxiety
Evaluated using Hospital Anxiety and Depression Scale (Turkish versions of all scales)
Measured: Seven day
Life of quality
Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales) is used to assess the quality of life of COPD patients.
Measured: Seven day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start20 Aug 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Pelin Dündar, Necmettin Erbakan University
- Investigators
- Zeynep Pelin DÜNDAR, MSc,PT, Principal investigator, Necmettin Erbakan UniversityNihan KAFA, Study director, Gazi UniversityHülya VATANSEV, Study director, Necmettin Erbakan UniversityNeslihan DURUTÜRK, Study chair, Baskent UniversityAdil ZAMANİ, Study chair, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563493
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao S, Wang F, Lin Q, Jian F, Li Y, Zhong Q, Huang Y, Lin Y, Wang H. Effect of sitting and lying Liuzijue exercise for pulmonary rehabilitation in acute exacerbation of chronic obstructive pulmonary disease patients with non-invasive ventilation: a randomized controlled trial. Ann Palliat Med. 2021 Sep;10(9):9914-9926. doi: 10.21037/apm-21-2157.
PubMed 34628916Knaut C, Bonfanti Mesquita C, Dourado VZ, de Godoy I, Tanni SE. Evaluation of Inflammatory Markers in Patients Undergoing a Short-Term Aerobic Exercise Program while Hospitalized due to Acute Exacerbation of COPD. Int J Inflam. 2020 Apr 28;2020:6492720. doi: 10.1155/2020/6492720. eCollection 2020.
PubMed 32411343Burtin C, Decramer M, Gosselink R, Janssens W, Troosters T. Rehabilitation and acute exacerbations. Eur Respir J. 2011 Sep;38(3):702-12. doi: 10.1183/09031936.00079111. Epub 2011 Jun 30.
PubMed 21719481Kon SS, Canavan JL, Man WD. Pulmonary rehabilitation and acute exacerbations of COPD. Expert Rev Respir Med. 2012 Nov;6(5):523-31; quiz 531. doi: 10.1586/ers.12.47.
PubMed 23134247Dundar ZP, Karatas N, Duruturk N, Vatansev H, Zamani̇ A. Effects of chair-based exercise training on pulmonary function, exercise capacity, and quality of life in patients with acute exacerbation of COPD: A randomised controlled trial. Physiotherapy. 2026 Sep 16;134:102386. doi: 10.1016/j.physio.2026.102386. Online ahead of print.
PubMed 42976662
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Chair-Based Exercise Training on Respiratory Functions, Exercise Capacity and Quality of Life in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05563493
- Acronym / sponsor ID
- 1
- Conditions
- Acute Exacerbation of COPD
- Keywords
- Chair-based exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Oct 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) is the leading cause of morbidity and mortality worldwide, a respiratory disease characterized by chronic airflow limitation that is not completely reversible.
Impaired pulmonary functions, decreased exercise capacity and quality of life and increased dyspnea perception is prevalent in patients with acute exacerbations of COPD.It was demonstrated exercise training has beneficial effects in patients with acute exacerbations of COPD.
The purpose of this study to evaluate the effects of chair-based exercise training on exercise capacity, respiratory functions, dyspnea, balance, depression anxiety and quality of life in COPD patients in acute exacerbation.
Detailed description
Acute exacerbations of COPD are generally defined as events in the natural course of the disease characterized by a change in the patient's initial dyspnea, cough or sputum beyond normal daily variations. The main consequences of COPD in acute exacerbation are increased mortality, deterioration in health-related quality of life, faster decline in lung function, marked reduction in physical activity and worsening of peripheral muscle weakness, which have a direct impact on patients' health. Although exacerbations are diagnosed based on respiratory symptoms, there is evidence that they have systemic consequences, including a detrimental effect on skeletal muscle function, exercise tolerance and quality of life.
Chair-based exercise training is defined as a structured and progressive exercise program applied by trainers that provides stability using a chair, which is a part of exercise training for the elderly. It is thought that it would be beneficial to study such an exercise program, since COPD patients in acute exacerbation have less mobilization during hospitalization.
In a limited number of studies, some inconsistencies were observed in the exercises of patients with acute exacerbation of COPD. Studies can therefore now focus on investigating comparisons between different intervention lengths, session durations and frequencies, and intensities of exercise training. For this reason, in our planned study, we will investigate the effects of chair-based exercise training in COPD patients in acute exacerbation. There is no study in the literature investigating the effects of chair-based exercise training in COPD patients in acute exacerbation. For this reason, our study will provide important information support to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group, Chair-Based Exercise Training | Experimental | Other: Treatment group, Chair-Based Exercise TrainingTreatment group will receive chair-based exercise training. Chair-based exercise training consisting of 20 different exercises will be applied in 2-3 sets with an average of 8-15 repetitions. Rest between sets will average 45-60 seconds. |
| Control group, Breathing exercise | Other | Other: Control group, Breathing exerciseControl group will receive breathing exercises. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were hospitalized due to acute exacerbation of COPD
Key exclusion criteria (3 listed)
- Patients with orthopedic or neurological problems that may interfere with assessment and education,
- Uncooperative patients,
- Patients with advanced heart problems such as acute coronary syndrome, stable angina pectoris, severe arrhythmias (Atrial fibrillation etc.), decompensated heart failure.
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 |
|---|---|---|
| Treatment group, Chair-Based Exercise TrainingThe weights of the elastic bands to be used in the exercises will be determined by the physiotherapist according to the abilities and development of the participants. The intensity of the exercise will be adjusted according to the dyspnea or fatigue patients feel according to the Modified Borg Scale. During the exercises, heart rate and oxygen saturation will be measured with a pulse oximeter, and blood pressure will be measured with a sphygmomanometer. Chair-based exercise training will be applied to the patients every day they are hospitalized. | Other | Treatment group, Chair-Based Exercise Training |
| Control group, Breathing exerciseBreathing exercise will be applied to the patients every day they are hospitalized. | Other | Control group, Breathing exercise |
Primary outcome
Functional Exercise Capacity
Time frame: Seven day
Functional exercise capacity will be evaluated with 6-minute walk test.
Pulmonary Function Test
Time frame: Seven day
This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values.
5 secondary outcomes
Dyspnea
Time frame: Seven day
One Minute Sit to Stand Test
Time frame: Seven day
Timed Up and Go Test
Time frame: Seven day
Depression and Anxiety
Time frame: Seven day
Life of quality
Time frame: Seven day
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 7 Feb 2024.
- Background: PubMed 34628916Liao S, Wang F, Lin Q, Jian F, Li Y, Zhong Q, Huang Y, Lin Y, Wang H. Effect of sitting and lying Liuzijue exercise for pulmonary rehabilitation in acute exacerbation of chronic obstructive pulmonary disease patients with non-invasive ventilation: a randomized controlled trial. Ann Palliat Med. 2021 Sep;10(9):9914-9926. doi: 10.21037/apm-21-2157.
- Background: PubMed 32411343Knaut C, Bonfanti Mesquita C, Dourado VZ, de Godoy I, Tanni SE. Evaluation of Inflammatory Markers in Patients Undergoing a Short-Term Aerobic Exercise Program while Hospitalized due to Acute Exacerbation of COPD. Int J Inflam. 2020 Apr 28;2020:6492720. doi: 10.1155/2020/6492720. eCollection 2020.
- Background: PubMed 21719481Burtin C, Decramer M, Gosselink R, Janssens W, Troosters T. Rehabilitation and acute exacerbations. Eur Respir J. 2011 Sep;38(3):702-12. doi: 10.1183/09031936.00079111. Epub 2011 Jun 30.
- Background: PubMed 23134247Kon SS, Canavan JL, Man WD. Pulmonary rehabilitation and acute exacerbations of COPD. Expert Rev Respir Med. 2012 Nov;6(5):523-31; quiz 531. doi: 10.1586/ers.12.47.
- Derived from this study: PubMed 42976662Dundar ZP, Karatas N, Duruturk N, Vatansev H, Zamani̇ A. Effects of chair-based exercise training on pulmonary function, exercise capacity, and quality of life in patients with acute exacerbation of COPD: A randomised controlled trial. Physiotherapy. 2026 Sep 16;134:102386. doi: 10.1016/j.physio.2026.102386. Online ahead of print.
- 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.
Zeynep Pelin DÜNDAR, MSc,PT principal investigator
Necmettin Erbakan University
Nihan KAFA study director
Gazi University
Hülya VATANSEV study director
Necmettin Erbakan 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 Treatment group, Chair-Based Exercise Training in people with Acute Exacerbation of COPD, run by Necmettin Erbakan 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 1 inclusion and 3 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 7 Feb 2024. 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?
Functional Exercise Capacity (time frame: Seven day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563493, which also lists 5 linked publications.
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 7 Feb 2024.