Impact of Pulmonary Rehabilitation on Loneliness in COPD

NCT ID: NCT05435963

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2023-11-30

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.

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.

Conditions

Loneliness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pulmonary rehabilitation (PR)

Intervention Type: BEHAVIORAL

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

Interventions

Pulmonary rehabilitation (PR)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Abbreviations:

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

Exclusion Criteria

• Do not have sufficient language skills (non-English speaking or reduced cognition)
• Are unable to complete at least 60% of PR
• Fail to complete the primary outcome measure, the University of California, and Los Angeles Loneliness scale (UCLA-LS).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dina Brooks, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

West Park Healthcare Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

AlsubheenS

Identifier Type: -

Identifier Source: org_study_id