NCT06201299

Brief Summary

Patients who are diagnosed with COPD by a pulmonology specialist and referred to pulmonary rehabilitation will be included in the study. Cases that meet the inclusion criteria will be randomized and divided into two groups, standard exercise program group (SGr) and chair-based exercise. program group will be called (ChGr). While standard exercises will be given to SGr, chair-based exercises will be applied to ChGr. All evaluation and initial training sessions of the cases will be held in the hospital. Apart from this, they will be asked to do their exercises at home with the exercise videos that will be sent to them. In order to ensure that home exercises are performed completely and correctly, 2 sessions of online simultaneous exercise training will be provided with a physiotherapist via videoconference on a smartphone, and exercise follow-ups will be carried out by calling once a week. The program duration is 8 weeks, 5 days a week.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

December 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

December 30, 2023

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity assesment

    The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.

    Change from baseline at 2 months

Secondary Outcomes (8)

  • Dyspnea evaluation

    Change from baseline at 2 months

  • Respiratory muscle strength measurement

    Change from baseline at 2 months

  • Peripheral muscle strength measurement

    Change from baseline at 2 months

  • Evaluation of quality of life

    Change from baseline at 2 months

  • Evaluation of fatigue

    Change from baseline at 2 months

  • +3 more secondary outcomes

Study Arms (2)

Chair-based Exercise Group

EXPERIMENTAL

Exercises will be performed with chair support.

Other: Chair-based Exercise Program

Standard Exercise Group

EXPERIMENTAL

Exercises will be performed using theraband.

Other: Standard Exercise Program

Interventions

The program content consists of breathing exercises, upper and lower extremity strengthening with theraband and self-walking. Chest, abdominal and lateral basal breathing exercises will be performed 10 times each. Resistance exercises will be performed as strengthening exercises for the major muscle groups of the upper and lower extremities using medium-hard theraband. Patients will be asked to walk 30 minutes a day on flat ground at 60% workload, for periods calculated according to the 6-minute walk test results (land-based walking).

Standard Exercise Group

The program content consists of breathing exercises and chair-supported exercises. Chest, abdominal and lateral basal breathing exercises will be performed 10 times each. Chair exercises are given in the exercise brochure. Exercises are performed with a chair support or sitting on a chair. In addition, patients will be asked to walk 30 minutes a day on flat ground at 60% workload, for periods calculated according to the 6-minute walk test results (land-based walking).

Chair-based Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-75 years
  • Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
  • Presence of dyspnea on exertion

You may not qualify if:

  • Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (˃ 3-4 L\\min).
  • A history of exertional syncope or the presence of any comorbidities (such as severe orthopedic or neurological deficits or unstable heart disease) that preclude exercise training.
  • Having participated in a pulmonary rehabilitation program within the last 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 11, 2024

Study Start

January 20, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations