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Completed

NCT Number: NCT05435963

Impact of Pulmonary Rehabilitation on Loneliness in COPD

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.

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Key information

Conditions

Loneliness

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

pulmonary rehabilitation (PR)

Behavioral

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

Primary outcomes

  1. The University of California and Los Angeles Loneliness scale (UCLA-LS)

    Time frame: 10 months

    Loneliness questionnaire. The UCLA-LS is a 20-item scale used to assess loneliness in the general population. Participants respond to each item on a 1-4 Likert scale, from "never" to "always". Positively worded items are reverse scored. The scale has a possible total score of 20 to 80 points, with a higher score indicating greater loneliness

Secondary outcomes

  1. Chronic Respiratory Disease Questionnaire (CRQ)

    Time frame: 10 months

    Quality of life questionnaire: composed of 20 items that measure the quality of life of individuals with COPD across four domains including dyspnea (five items), fatigue (four items), emotional function (seven items), and mastery (four items). Scoring for each item ranges from one (maximum impairment) to seven (no impairment), with high scores indicating less impairments.

  2. Generalized Anxiety Disorder - 7 (GAD - 7) Measure

    Time frame: 10 months

    Anxiety will be assessed using the GAD - 7. The GAD - 7 is a 7 - item self-report questionnaire measuring symptoms of anxiety experienced in the preceding two weeks. Responses are assigned a score of 0, 1, 2, or 3 to reflect "not at all", "several days", "more than half the days", or "nearly everyday" respectively. A total score is calculated with scores of 5, 10 and 15 indicating mild, moderate and severe anxiety respectively.

  3. 6-Minute Walk Test

    Time frame: 10 months

    Measure of exercise tolerance

  4. Patient Health Questionnaire - 9 (PHQ - 9)

    Time frame: 10 months

    Depression will be assessed using the PHQ - 9 23. The PHQ-9 is a 9-item self-report questionnaire measuring symptoms of depression experienced in the preceding two weeks. Responses are assigned a score of 0, 1, 2, or 3 to reflect "not at all", "several days", "more than half the days", or "nearly everyday" respectively 23. A total score is calculated with scores of 5, 10, 15 and 20 indicating mild, moderate, moderately severe and severe depression respectively

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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