LonelinessNCT05435963
Impact of Pulmonary Rehabilitation on Loneliness in COPD
A study testing Pulmonary rehabilitation (PR) in people with Loneliness, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Loneliness
- What is being tested?
- Pulmonary rehabilitation (PR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulmonary Rehabilitation on Reducing Loneliness in Individuals With Chronic Obstructive Pulmonary Disease (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.
Read the 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
- Being tested
- Pulmonary rehabilitation (PR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation (PR)Behavioural
A typical PR program will include exercise training, disease-specific and self-management strategies education, and will last 6 - 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pulmonary rehabilitation (PR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 months
Secondary outcomes (4)
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.
Measured: 10 months
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.
Measured: 10 months
6-Minute Walk Test
Measure of exercise tolerance
Measured: 10 months
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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start23 Jan 2023
- Primary completion31 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dina Brooks, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435963
- Sponsor's protocol ID
- AlsubheenS
- Status last verified
- May 2025
- First submitted
- 22 Jun 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Rehabilitation on Reducing Loneliness in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05435963
- Acronym / sponsor ID
- AlsubheenS
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD undergoing pulmonary rehabilitation | Experimental | Behavioral: Pulmonary rehabilitation (PR)45 individuals with COPD will complete the UCLA-LS scale, CRQ, HADS, and 6 minute walk test before and after pulmonary rehabilitation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- FEV1: forced expiratory volume in 1 second FVC: forced vital capacity
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation (PR)A typical PR program will include exercise training, disease-specific and self-management strategies education, and will last 6 - 8 weeks | Behavioural | COPD undergoing pulmonary rehabilitation |
Primary outcome
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
4 secondary outcomes
Chronic Respiratory Disease Questionnaire (CRQ)
Time frame: 10 months
Generalized Anxiety Disorder - 7 (GAD - 7) Measure
Time frame: 10 months
6-Minute Walk Test
Time frame: 10 months
Patient Health Questionnaire - 9 (PHQ - 9)
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Brooks, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation (PR) in people with Loneliness, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The University of California and Los Angeles Loneliness scale (UCLA-LS) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.