- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820257
Home-based Pulmonary Rehabilitation for COPD Patients
Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR.
The program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors.
The proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific aims will guide the proposed project:
- Aim 1: To determine the feasibility of the proposed home-based PR program. We will additionally address adherence and appropriateness of the program.
- Aim 2: To determine improvements in quality of life and mental health of the proposed home-based PR determined.
- Aim 3: To evaluate if the average number of daily step counts increase after the home-based PR program
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marian Papp, PhD
- Phone Number: +46706946553
- Email: marian.papp@ki.se
Study Locations
-
-
-
Stockholm, Sweden
- Karolinska Institutet
-
Contact:
- Marian Papp, PhD
- Phone Number: +46706946553
- Email: marian.papp@ki.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women age 40 years and older
- FEV1 <80% or less (forced expiratory volume in one second) as documented by pulmonary function.
- Medical diagnosis of COPD, GOLD classification B,D, and C based on symptoms and history of exacerbations.
- The patients must be able to access a smart-phone or computer tablet with internet service.
Exclusion Criteria:
- Unable to perform low intensity exercise.
- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move, are not living in the healthcare area.
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home based exercise
Home based exercise with health coaching
|
Exercise at home and behavioural change to increase daily exercise
|
|
No Intervention: Usual care
Usual care, waiting list
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease specific quality of life
Time Frame: 8-12 weeks
|
Chronic Respiratory Questionnaire (CRQ)
|
8-12 weeks
|
|
Modified Medical Research Council Dyspnea scale (mMRC),
Time Frame: 8-12 weeks
|
Dyspnea
|
8-12 weeks
|
|
COPD assessment Test (CAT)
Time Frame: 8-12 weeks
|
assess symptoms of breathing
|
8-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GAD to asses anxiety and depression symptoms
Time Frame: 8-12 weeks
|
assessing anxiety and depression symptoms
|
8-12 weeks
|
|
Online breathing and mindful movement exercises/ exercise routine
Time Frame: 8-12 weeks
|
Total time performing the breathing exercises
|
8-12 weeks
|
|
Activity monitoring
Time Frame: 8-12 weeks
|
number of steps
|
8-12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marian Papp, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-01151:DNR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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