Home-based Pulmonary Rehabilitation for COPD Patients

Sponsor

Karolinska Institutet (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04820257

Collaborator

Mayo Clinic (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD, Chronic Obstructive Pulmonary Disease	Behavioral: Home based exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

starting with a small pilot and will follow with parallell design RCT - starting laterstarting with a small pilot and will follow with parallell design RCT - starting later

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Home-based Pulmonary Rehabilitation for COPD Patients

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Home based exercise Home based exercise with health coaching	Behavioral: Home based exercise Exercise at home and behavioural change to increase daily exercise
No Intervention: Usual care Usual care, waiting list

Arm

Intervention/Treatment

Experimental: Home based exercise

Home based exercise with health coaching

Behavioral: Home based exercise

Exercise at home and behavioural change to increase daily exercise

No Intervention: Usual care

Usual care, waiting list

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).