Home-based Pulmonary Rehabilitation for COPD Patients

Not Applicable

Not yet recruiting

• Conditions: COPD, Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Home based exercise

• Registration Number: NCT04820257
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Study Start: 2025-01-01
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home based exercise	Home based exercise	Home based exercise with health coaching

Primary Outcome Measures

Name	Time	Method
Disease specific quality of life	8-12 weeks	Chronic Respiratory Questionnaire (CRQ)
Modified Medical Research Council Dyspnea scale (mMRC),	8-12 weeks	Dyspnea
COPD assessment Test (CAT)	8-12 weeks	assess symptoms of breathing

Secondary Outcome Measures

Name	Time	Method
GAD to asses anxiety and depression symptoms	8-12 weeks	assessing anxiety and depression symptoms
Online breathing and mindful movement exercises/ exercise routine	8-12 weeks	Total time performing the breathing exercises
Activity monitoring	8-12 weeks	number of steps

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden