- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04694729
Telerehabilitation Approaches in Chronic Obstructive Pulmonary Patients
January 4, 2021 updated by: Nursima Bulut, Saglik Bilimleri Universitesi
Comparison of the Effectiveness of Different Telerehabilitation Approaches in Chronic Obstructive Pulmonary Patients
Pulmonary rehabilitation (PR) is a first-line management strategy in chronic obstructive pulmonary patients (COPD) as it reduces shortness of breath, increases exercise capacity, and improves health-related quality of life.
However, 8-50% of patients referred to PR do not participate at all, while 10-32% of those who start do not complete the program.
Barriers to participation and completion include difficulty in accessing the program, poor mobility, lack of transport, and travel costs.
Telerehabilitation is defined as the provision of rehabilitation services through telecommunication technology, including telephone, internet and video conference communications between the patient and the healthcare provider.
Different technologies (from phone to video conferencing) have been tested in patients with COPD to enhance daily activities, exercise training and walking prescription.
All of them showed positive effects on exercise tolerance, dyspnea, physical activity and quality of life.
However, there is no study about which telerehabilitation program is more effective on COPD patients.
The aim of this study is to investigate which telerehabilitation approach is more effective in COPD.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being diagnosed with COPD (FEV1 / FVC <70% in the stable phase of the disease)
- Age > 18 years old
- Have the ability to use a smartphone
Exclusion Criteria:
- Musculoskeletal disorders that limit exercise
- Dizziness, significant sensory or motor impairments, dementia or terminal illnesses that prevent education
- Serious comorbidities such as unstable heart disease, irregular diabetes, known malignant disease, any other disease that makes the patient unsuitable for participation in the study.
- Incompatible patient
- Severe vision or hearing impairment
- Unwillingness or inability to follow the protocol
- Have had a COPD exacerbation in the previous 6 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
Videoconference-based
|
Exercises will be done 3 days a week for 6 weeks, with the help of a physiotherapist via video conference.
|
|
Experimental: control group
Video-based
|
The exercise video will be sent to the patients and they will do it 3 days a week for 6 weeks.
The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
6 minute walk test(6MWT)
Time Frame: 6 week
|
6 week
|
|
Pulmonary function testing
Time Frame: 6 week
|
6 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
30-Second Chair Stand Test
Time Frame: 6 week
|
6 week
|
|
Time Up and Go Test
Time Frame: 6 week
|
6 week
|
|
Copd Assessment Test
Time Frame: 6 week
|
6 week
|
|
St George's Respiratory Questionnaire
Time Frame: 6 week
|
6 week
|
|
Hospital Anxiety and Depression Scale
Time Frame: 6 week
|
6 week
|
|
Medical Research Council Scale
Time Frame: 6 week
|
6 week
|
|
Short Physical Performance Battery
Time Frame: 6 week
|
6 week
|
|
International Physical Activity Questionnaire-Short Form
Time Frame: 6 week
|
6 week
|
|
Static Lung Volumes
Time Frame: 6 week
|
6 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
January 2, 2021
First Submitted That Met QC Criteria
January 2, 2021
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 4, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- TeleCOPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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