Impact of Pulmonary Rehabilitation on Loneliness in COPD

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435963
• Other study ID #: AlsubheenS
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: Sanaa Alsubheen, PhD
• Phone: 5198789647
• Email: alsubhes[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Loneliness

Intervention

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

Locations

Country	Name	City	State
Canada	West Park Healthcare Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The University of California and Los Angeles Loneliness scale (UCLA-LS)	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	10 months
Secondary	Chronic Respiratory Disease Questionnaire (CRQ)	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.	10 months
Secondary	Generalized Anxiety Disorder - 7 (GAD - 7) Measure	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.	10 months
Secondary	6-Minute Walk Test	Measure of exercise tolerance	10 months
Secondary	Patient Health Questionnaire - 9 (PHQ - 9)	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	10 months