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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05563493
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2022
Est. completion date June 30, 2023

Study information

Verified date September 2022
Source Necmettin Erbakan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Treatment group, Chair-Based Exercise Training
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 exercise
Breathing exercise will be applied to the patients every day they are hospitalized.

Locations

Country Name City State
Turkey Necmettin Erbakan University Nezahat Kelesoglu Faculty of Health Sciences Konya

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Exercise Capacity Functional exercise capacity will be evaluated with 6-minute walk test. Seven day
Primary Pulmonary Function Test This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values. Seven day
Secondary Dyspnea The severity of dyspnea during daily living activities is evaluated using the Modified Medical Research Council (MMRC) dyspnea scale. Seven day
Secondary 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. Seven day
Secondary Timed Up and Go Test The Timed Up and Go test is evaluated dynamic balance. Seven day
Secondary Depression and Anxiety Evaluated using Hospital Anxiety and Depression Scale (Turkish versions of all scales) Seven day
Secondary 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. Seven day
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