NCT04879576

Brief Summary

Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Pulmonary rehabilitation has proven to be the best supportive treatment for individuals with COPD. However, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. There are different studies demonstrating the effect of telerehabilitation in COPD patients and confirming that it is safe, but it is a developing area and has a limited area of use. In this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with COPD via video conferencing including respiratory exercises and postural exercises.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

May 5, 2021

Last Update Submit

May 5, 2021

Conditions

Keywords

Telerehabilitation

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline in respiratory functions on the spirometry at week 8

    Spirometry is a standard test doctors use to measure how well your lungs are functioning. The test works by measuring airflow into and out of your lungs.Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).

    Baseline - Week 8

  • Change from Baseline in exercise capacity on six-minute walk test at week 8

    The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.A lower score (reflecting less distance covered in 6 minutes) indicates worse function.

    Baseline - Week 8

  • Change from Baseline in health-related quality of life on Saint George's Respiratory Questionnaire at week 8

    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.

    Baseline - Week 8

  • Change from Baseline in psychosocial factors on Beck Depression and Beck Anxiety Inventory at week 8

    Beck Depression Inventory is a self-assessment scale that determines the risk of individuals in terms of depression and measures the level of depressive symptoms and the change in severity.Beck Anxiety Inventory is a likert type self-assessment scale that determines the frequency of anxiety symptoms experienced by individuals. The high score the individual gets from the scale indicates the severity of anxiety experienced.

    Baseline - Week 8

  • Change from Baseline in fatigue on COPD and Asthma Fatigue Scale at week 8

    The COPD and Asthma Fatigue Scale , was developed for use in clinical trials and other studies in respiratory diseases. The COPD and Asthma Fatigue Scale was intended to be sufficiently comprehensive to capture fatigue experienced by patients with either asthma or COPD, yet be brief and patient centered.

    Baseline - Week 8

Secondary Outcomes (1)

  • Change from Baseline in dyspnea on Modified Medical Research Council Dyspnea Scale at week 8

    Baseline - Week 8

Study Arms (2)

Treatment Group

EXPERIMENTAL
Other: Treatment

Control Group

NO INTERVENTION

Interventions

Telerehabilitation including pulmonary rehabilitation and posture exercises at 8 weeks in total with 2 sessions per week

Also known as: telerehabilitation
Treatment Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
  • Not having an attack in the last 2 months
  • Volunteering to participate in the study
  • Being between the ages of 40-80
  • To have a device that can be used in telerehabilitation application and an active internet connection.

You may not qualify if:

  • Unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations
  • Currently addicted to alcohol or drugs
  • Having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation
  • Having serious vision and hearing problems
  • Having severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale High Specialization Hospital

Kırıkkale, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Avci B, Sertel M, Demir S. The effect of posture and breathing exercises applied with telerehabilitation on respiratory functions, exercise capacity, fatigue, and psychosocial factors in chronic obstructive pulmonary disease patients. J Bodyw Mov Ther. 2025 Dec;45:953-961. doi: 10.1016/j.jbmt.2025.09.046. Epub 2025 Oct 16.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

TherapeuticsTelerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Beyza Karakaş

    Graduate student at Kırıkkale University

    STUDY DIRECTOR
  • Meral Sertel

    Associate professor at Kırıkkale University

    STUDY CHAIR
  • Selma Demir

    Chest Diseases Specialist at Kırıkkale High Specialization Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

April 1, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations