Back to resultsHome-based Pulmonary Rehabilitation for COPD Patients
Primary Purpose
COPD, Chronic Obstructive Pulmonary Disease
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Home based exercise
Sponsored by
About this trial
This is an interventional health services research trial for COPD, Chronic Obstructive Pulmonary Disease focused on measuring tele-health, behavioural change, motivational interviewing, home-based exercise, self-related health, quality of life
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).
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Home based exercise
Usual care
Arm Description
Home based exercise with health coaching
Usual care, waiting list
Outcomes
Primary Outcome Measures
Disease specific quality of life
Chronic Respiratory Questionnaire (CRQ)
Modified Medical Research Council Dyspnea scale (mMRC),
Dyspnea
COPD assessment Test (CAT)
assess symptoms of breathing
Secondary Outcome Measures
GAD to asses anxiety and depression symptoms
assessing anxiety and depression symptoms
Online breathing and mindful movement exercises/ exercise routine
Total time performing the breathing exercises
Activity monitoring
number of steps
Full Information
NCT ID
NCT04820257
First Posted
March 24, 2021
Last Updated
May 10, 2023
Sponsor
Karolinska Institutet
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04820257
Brief Title
Home-based Pulmonary Rehabilitation for COPD Patients
Official Title
Home-based Pulmonary Rehabilitation for COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Obstructive Pulmonary Disease
Keywords
tele-health, behavioural change, motivational interviewing, home-based exercise, self-related health, quality of life
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
starting with a small pilot and will follow with parallell design RCT - starting later
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home based exercise
Arm Type
Experimental
Arm Description
Home based exercise with health coaching
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care, waiting list
Intervention Type
Behavioral
Intervention Name(s)
Home based exercise
Intervention Description
Exercise at home and behavioural change to increase daily exercise
Primary Outcome Measure Information:
Title
Disease specific quality of life
Description
Chronic Respiratory Questionnaire (CRQ)
Time Frame
8-12 weeks
Title
Modified Medical Research Council Dyspnea scale (mMRC),
Description
Dyspnea
Time Frame
8-12 weeks
Title
COPD assessment Test (CAT)
Description
assess symptoms of breathing
Time Frame
8-12 weeks
Secondary Outcome Measure Information:
Title
GAD to asses anxiety and depression symptoms
Description
assessing anxiety and depression symptoms
Time Frame
8-12 weeks
Title
Online breathing and mindful movement exercises/ exercise routine
Description
Total time performing the breathing exercises
Time Frame
8-12 weeks
Title
Activity monitoring
Description
number of steps
Time Frame
8-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Papp, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Home-based Pulmonary Rehabilitation for COPD Patients
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