Clinical trial NCT04820257: Home-based Pulmonary Rehabilitation for COPD Patients
Official title: Home-based Pulmonary Rehabilitation for COPD Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD, Chronic Obstructive Pulmonary Disease
Keywords: tele-health
behavioural change
motivational interviewing
home-based exercise
self-related health
quality of life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: starting with a small pilot and will follow with parallell design RCT - starting later
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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).

Primary outcomes:
measure: Disease specific quality of life
timeFrame: 8-12 weeks
measure: Modified Medical Research Council Dyspnea scale (mMRC),
timeFrame: 8-12 weeks
measure: COPD assessment Test (CAT)
timeFrame: 8-12 weeks
Secondary outcomes:
measure: GAD to asses anxiety and depression symptoms
timeFrame: 8-12 weeks
measure: Online breathing and mindful movement exercises/ exercise routine
timeFrame: 8-12 weeks
measure: Activity monitoring
timeFrame: 8-12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Marian Papp, PhD
role: PRINCIPAL_INVESTIGATOR
References: