NCT05435963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

June 22, 2022

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Chronic Respiratory Disease Questionnaire (CRQ)

    10 months

  • Generalized Anxiety Disorder - 7 (GAD - 7) Measure

    10 months

  • 6-Minute Walk Test

    10 months

  • Patient Health Questionnaire - 9 (PHQ - 9)

    10 months

Study Arms (1)

COPD undergoing pulmonary rehabilitation

EXPERIMENTAL

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)

Interventions

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

COPD undergoing pulmonary rehabilitation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Study Officials

  • Dina Brooks, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 28, 2022

Study Start

January 23, 2023

Primary Completion

October 31, 2023

Study Completion

November 30, 2023

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations