Clinical trial NCT05435963: Impact of Pulmonary Rehabilitation on Loneliness in COPD
Official title: Effect of Pulmonary Rehabilitation on Reducing Loneliness in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: The University of California and Los Angeles Loneliness scale (UCLA-LS)
timeFrame: 10 months
Secondary outcomes:
measure: Chronic Respiratory Disease Questionnaire (CRQ)
timeFrame: 10 months
measure: Generalized Anxiety Disorder - 7 (GAD - 7) Measure
timeFrame: 10 months
measure: 6-Minute Walk Test
timeFrame: 10 months
measure: Patient Health Questionnaire - 9 (PHQ - 9)
timeFrame: 10 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Dina Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References: