NCT04820257

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Nov 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
5.6 years until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

March 24, 2021

Last Update Submit

June 23, 2026

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Keywords

tele-healthbehavioural changemotivational interviewinghome-based exerciseself-related healthquality of life

Outcome Measures

Primary Outcomes (3)

  • 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 (3)

  • GAD to asses anxiety and depression symptoms

    8-12 weeks

  • Online breathing and mindful movement exercises/ exercise routine

    8-12 weeks

  • Activity monitoring

    8-12 weeks

Study Arms (2)

Home based exercise

EXPERIMENTAL

Home based exercise with health coaching

Behavioral: Home based exercise

Usual care

NO INTERVENTION

Usual care, waiting list

Interventions

Home based exerciseBEHAVIORAL

Exercise at home and behavioural change to increase daily exercise

Home based exercise

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 37811474RESULT

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marian Papp, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marian Papp, PhD

CONTACT

+46706946553marian.papp@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: starting with a small pilot and will follow with parallell design RCT - starting later
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 26, 2026

Record last verified: 2026-06

Locations

SE(1)