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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04820257
Other study ID # 2021-01151:DNR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2025
Est. completion date December 2028

Study information

Verified date February 2024
Source Karolinska Institutet
Contact Marian Papp, PhD
Phone +46706946553
Email marian.papp@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 2028
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 40 Years to 100 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease specific quality of life Chronic Respiratory Questionnaire (CRQ) 8-12 weeks
Primary Modified Medical Research Council Dyspnea scale (mMRC), Dyspnea 8-12 weeks
Primary COPD assessment Test (CAT) assess symptoms of breathing 8-12 weeks
Secondary GAD to asses anxiety and depression symptoms assessing anxiety and depression symptoms 8-12 weeks
Secondary Online breathing and mindful movement exercises/ exercise routine Total time performing the breathing exercises 8-12 weeks
Secondary Activity monitoring number of steps 8-12 weeks
See also
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Completed NCT02937584 - A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD Phase 3