Home-based Pulmonary Rehabilitation for COPD Patients | NCT04820257

Studies
Home-based Pulmonary Rehabilitation for COPD Patients

NCT04820257

Sponsor

Karolinska Institutet

Status

Not yet recruiting

Last Update Posted

Jun 26, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Interventions

Home based exercise

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Mar 24, 2021

First Submission Date that Met QC Criteria

Mar 24, 2021

First Posted Date

Mar 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home based exercise	Experimental	Home based exercise with health coaching	Behavioral: Home based exercise
Usual care	No Intervention	Usual care, waiting list

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home based exercise	Behavioral	Exercise at home and behavioural change to increase daily exercise	Home based exercise

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
GAD to asses anxiety and depression symptoms	assessing anxiety and depression symptoms	8-12 weeks
Online breathing and mindful movement exercises/ exercise routine	Total time performing the breathing exercises

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marian Papp, PhD	Contact	+46706946553		marian.papp@ki.se

Overall Officials

Name	Affiliation	Role
Marian Papp, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet		Stockholm			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37811474	Result	Benzo MV, Hagstromer M, Nygren-Bonnier M, Benzo RP, Papp ME. Home-Based Physical Activity Program With Health Coaching for participants With Chronic Obstructive Pulmonary Disease in Sweden: A Proof-of-Concept Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2023 Sep 30;7(5):470-475. doi: 10.1016/j.mayocpiqo.2023.07.005. eCollection 2023 Oct.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease