- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563493
Effects of Chair-Based Exercise Training on Exercise Capacity in Patients With Acute Exacerbation of COPD
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey, 42090
- Necmettin Erbakan University Nezahat Kelesoglu Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who were hospitalized due to acute exacerbation of COPD
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment group, Chair-Based Exercise Training
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.
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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. |
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Other: Control group, Breathing exercise
Control group will receive breathing exercises.
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Breathing exercise will be applied to the patients every day they are hospitalized.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Exercise Capacity
Time Frame: Seven day
|
Functional exercise capacity will be evaluated with 6-minute walk test.
|
Seven day
|
|
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.
|
Seven day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea
Time Frame: Seven day
|
The severity of dyspnea during daily living activities is evaluated using the Modified Medical Research Council (MMRC) dyspnea scale.
|
Seven day
|
|
One Minute Sit to Stand Test
Time Frame: Seven day
|
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.
|
Seven day
|
|
Timed Up and Go Test
Time Frame: Seven day
|
The Timed Up and Go test is evaluated dynamic balance.
|
Seven day
|
|
Depression and Anxiety
Time Frame: Seven day
|
Evaluated using Hospital Anxiety and Depression Scale (Turkish versions of all scales)
|
Seven day
|
|
Life of quality
Time Frame: Seven day
|
Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales) is used to assess the quality of life of COPD patients.
|
Seven day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeynep Pelin DÜNDAR, MSc,PT, Necmettin Erbakan University
- Study Director: Nihan KAFA, Gazi University
- Study Director: Hülya VATANSEV, Necmettin Erbakan University
- Study Chair: Neslihan DURUTÜRK, Baskent University
- Study Chair: Adil ZAMANİ, Necmettin Erbakan University
Publications and helpful links
General 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.
- Knaut 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.
- Burtin 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.
- Kon 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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