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Not yet recruiting NCT04820257

Home-based Pulmonary Rehabilitation for COPD Patients

No phase Interventional COPD, Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home based exercise.
Who it may be relevant to
Registry conditions: COPD, Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral Home based exercise
    Exercise at home and behavioural change to increase daily exercise

Primary outcome measures

  • Disease specific quality of life [Time frame: 8-12 weeks]
  • Modified Medical Research Council Dyspnea scale (mMRC), [Time frame: 8-12 weeks]
  • COPD assessment Test (CAT) [Time frame: 8-12 weeks]
Secondary outcome measures (3)
  • GAD to asses anxiety and depression symptoms [Time frame: 8-12 weeks]
  • Online breathing and mindful movement exercises/ exercise routine [Time frame: 8-12 weeks]
  • Activity monitoring [Time frame: 8-12 weeks]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Sweden · 1 center
  • Karolinska Institutet — Stockholm

Publications

  • 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 37811474

Identifiers

NCT: NCT04820257 · 2021-01151:DNR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗