Impact of Pulmonary Rehabilitation on Loneliness in COPD

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05435963

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Loneliness is the feeling of sadness because one wants friends or company. This feeling is common in patients with chronic lung disease, who suffer from breathing difficulty, chronic cough, and reduced physical and mental health. These problems lead to a reduced ability for doing daily activities and cause a loss of social life. Pulmonary rehabilitation (PR) includes exercise and education. PR has been shown to improve health status in patients with chronic lung disease but its impact on loneliness levels has never been assessed. This study aims to assess the effect of PR on reducing loneliness in patients with chronic lung disease.

Condition or Disease	Intervention/Treatment	Phase
Loneliness	Behavioral: Pulmonary rehabilitation (PR)	N/A

Detailed Description

Pulmonary rehabilitation (PR), composed of exercise training, education, and self-management strategies, is the standard of care for managing individuals with chronic obstructive pulmonary disease (COPD). PR improves dyspnea, functional exercise capacity, health-related quality of life and decreases hospitalizations and mortality. Regular exercise has been shown to reduce loneliness in older adults and those with chronic conditions, in association with a reduction in pain, the development of friendly relationships and enhanced psychological well-being. However, there is limited information regarding the impact of PR on the level of loneliness in individuals with COPD.

Study Purpose The purpose of this study is to examine the effect of PR on loneliness levels in individuals with COPD and to examine the relationship between changes in loneliness and changes in exercise capacity, health-related quality of life, depression, and anxiety levels.

This pre-post interventional study will be conducted at the West Park Healthcare Centre and St. Joseph's Healthcare Hamilton. Ethics approval will be obtained from the Joint West Park Healthcare Centre - The Salvation Army Toronto Grace Health Centre Research Ethics Board (JREB) and the Hamilton Integrated Research Ethics Board (HiREB).

Participants Based on Mimi et al. (2014), a sample size of 45 participants is required to detect minimal significant effects on the University of California & Los-Angeles Loneliness scale (UCLA-LS), with 80% power (α= 0.05, β= 0.20) and assuming a drop-out rate of 25%. The sample will include male and female individuals who have been diagnosed with COPD.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Pulmonary Rehabilitation on Reducing Loneliness in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COPD undergoing pulmonary rehabilitation 45 individuals with COPD will complete the UCLA-LS scale, CRQ, HADS, and 6 minute walk test before and after pulmonary rehabilitation.	Behavioral: Pulmonary rehabilitation (PR) A typical PR program will include exercise training, disease-specific and self-management strategies education, and will last 6 - 8 weeks

Arm

Intervention/Treatment

Experimental: COPD undergoing pulmonary rehabilitation

45 individuals with COPD will complete the UCLA-LS scale, CRQ, HADS, and 6 minute walk test before and after pulmonary rehabilitation.

Behavioral: Pulmonary rehabilitation (PR)

A typical PR program will include exercise training, disease-specific and self-management strategies education, and will last 6 - 8 weeks

Outcome Measures

Primary Outcome Measures

The University of California and Los Angeles Loneliness scale (UCLA-LS) [10 months]
Loneliness questionnaire

Secondary Outcome Measures

Chronic Respiratory Disease Questionnaire (CRQ) [10 months]
Quality of life questionnaire
Hospital Anxiety and Depression Scale (HADS) [10 months]
Anxiety and depression questionnaire
6-Minute Walk Test [10 months]
Measure of exercise tolerance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A spirometry (FEV1/FVC < 0.70) or physician-confirmed diagnosis of COPD; (2) aged 18 years or more; (3) ability to complete at least 60% of the PR program that includes exercise, education, and behaviour change intervention; and (4) ability to provide written informed consent.

FEV1: forced expiratory volume in 1 second FVC: forced vital capacity

Exclusion Criteria:

(1) do not have sufficient language skills (non-English speaking or reduced cognition), (2) are unable to complete at least 60% of PR, and (3) fail to complete the primary outcome measure, the University of California, and Los Angeles Loneliness scale (UCLA-LS).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

McMaster University

Investigators

Principal Investigator: Dina Brooks, PhD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

McMaster University

ClinicalTrials.gov Identifier:

NCT05435963

Other Study ID Numbers:

AlsubheenS

First Posted:

Jun 28, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 28, 2022