NCT05563493

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 7, 2024

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

September 26, 2022

Last Update Submit

February 6, 2024

Conditions

Keywords

Chair-based exercise training

Outcome Measures

Primary Outcomes (2)

  • Functional Exercise Capacity

    Functional exercise capacity will be evaluated with 6-minute walk test.

    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.

    Seven day

Secondary Outcomes (5)

  • Dyspnea

    Seven day

  • One Minute Sit to Stand Test

    Seven day

  • Timed Up and Go Test

    Seven day

  • Depression and Anxiety

    Seven day

  • Life of quality

    Seven day

Study Arms (2)

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.

Other: Treatment group, Chair-Based Exercise Training

Control group, Breathing exercise

OTHER

Control group will receive breathing exercises.

Other: Control group, Breathing exercise

Interventions

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.

Treatment group, Chair-Based Exercise Training

Breathing exercise will be applied to the patients every day they are hospitalized.

Control group, Breathing exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were hospitalized due to acute exacerbation of COPD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Nezahat Keleşoğlu Faculty of Health Sciences

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 34628916BACKGROUND
  • 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.

    PMID: 32411343BACKGROUND
  • 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.

    PMID: 21719481BACKGROUND
  • 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.

    PMID: 23134247BACKGROUND

MeSH Terms

Interventions

Control GroupsBreathing Exercises

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Zeynep Pelin DÜNDAR, MSc,PT

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • Nihan KAFA

    Gazi University

    STUDY DIRECTOR
  • Hülya VATANSEV

    Necmettin Erbakan University

    STUDY DIRECTOR
  • Neslihan DURUTÜRK

    Baskent University

    STUDY CHAIR
  • Adil ZAMANİ

    Necmettin Erbakan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 3, 2022

Study Start

August 20, 2022

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

February 7, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations