Pulmonary Disease, Chronic ObstructiveNCT02695342
Home Balance Pilot for Fall Reduction in COPD
A study testing Home balance exercise program in people with Pulmonary Disease, Chronic Obstructive, run by McMaster University at 2 sites in Canada.
Trial summary
There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Home balance exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2016to 31 Dec 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a clinical diagnosis of COPD;
- age ≥ 60 yrs;
- a history of 1 or more falls in the previous year;
- ability to provide written informed consent.
Who cannot join
- inability to communicate in English;
- history of significant cardiovascular disease;
- marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity;
- severe cognitive impairment;
- evidence of a condition that severely limits mobility and may jeopardize safety;
- completion of a course of rehabilitation in the last 6 months or on a wait list for admission to rehabilitation.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
West Park Healthcare Centre
Toronto, Ontario, M6M 2J6
About this study
Official title: Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD
There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in Canada. There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.
The primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with COPD in terms of recruitment, retention and adherence. The secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability.
Thirty-five older adults with COPD will be recruited from respirology clinics at West Park Healthcare Centre (Toronto) and the Firestone Institute for Respiratory Health (Hamilton) to participate in a single-group, non-randomized clinical trial. Eligible participants will be enrolled in a 6-month balance home exercise intervention. The home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Home balance exercise program
- Keywords
- Balance, Falls, Exercise, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home balance exercise programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Home balance exercise program | Experimental | The home-based exercise program will be tailored to address the underlying balance deficits in COPD and individualized according to each participant's ability. Physiotherapists will teach the program in four home visits over the first 6 weeks of the study; in the event of an exacerbation, a fifth visit will be provided to modify the program. Participants will be given an exercise DVD (with portable player), and will be instructed to perform the program 3 times/week for 6 months. Therapists will provide bi-monthly telephone support. Receives: Behavioral: Home balance exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of eligible patients that consent to enroll in the study
Measured: Baseline
Retention rate
Percentage of the sample that complete all 3 outcome assessments
Measured: 6 months
Compliance
Mean number of prescribed exercise sessions completed
Measured: 6 months
Secondary outcomes (5)
Berg Balance Scale
Measure of balance
Measured: baseline, 3 months, 6 months
Balance Evaluation Systems Test (BESTest)
Measure of balance
Measured: baseline, 3 months, 6 months
Activity-Specific Balance Confidence questionnaire
Measure of balance confidence
Measured: baseline, 3 months, 6 months
30-second Sit-to-Stand Test
Measure of functional lower body strength
Measured: baseline 3 months, 6 months
Self-reported function (PF-10)
Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- West Park Healthcare Centre
- Responsible party
- Sponsor
- Investigators
- Marla K Beauchamp, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695342
- Sponsor's protocol ID
- Labarge-20004484
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2016
- Last updated
- 26 Apr 2023
- 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Tailored Home Balance Exercise Program for Reducing Falls in Older Adults With COPD
- ClinicalTrials.gov ID
- NCT02695342
- Acronym / sponsor ID
- Labarge-20004484
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Balance, Falls, Exercise, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- West Park Healthcare Centre
- Study start
- 1 Mar 2016
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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.
There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in Canada. There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.
The primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with COPD in terms of recruitment, retention and adherence. The secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability.
Thirty-five older adults with COPD will be recruited from respirology clinics at West Park Healthcare Centre (Toronto) and the Firestone Institute for Respiratory Health (Hamilton) to participate in a single-group, non-randomized clinical trial. Eligible participants will be enrolled in a 6-month balance home exercise intervention. The home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home balance exercise program | Experimental | Behavioral: Home balance exercise programThe home-based exercise program will be tailored to address the underlying balance deficits in COPD and individualized according to each participant's ability. Physiotherapists will teach the program in four home visits over the first 6 weeks of the study; in the event of an exacerbation, a fifth visit will be provided to modify the program. Participants will be given an exercise DVD (with portable player), and will be instructed to perform the program 3 times/week for 6 months. Therapists will provide bi-monthly telephone support. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a clinical diagnosis of COPD;
- age ≥ 60 yrs;
- a history of 1 or more falls in the previous year;
- ability to provide written informed consent.
Key exclusion criteria (6 listed)
- inability to communicate in English;
- history of significant cardiovascular disease;
- marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity;
- severe cognitive impairment;
- evidence of a condition that severely limits mobility and may jeopardize safety;
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 |
|---|---|---|
| Home balance exercise program | Behavioural | Home balance exercise program |
Primary outcome
Recruitment rate
Time frame: Baseline
Percentage of eligible patients that consent to enroll in the study
Retention rate
Time frame: 6 months
Percentage of the sample that complete all 3 outcome assessments
Compliance
Time frame: 6 months
Mean number of prescribed exercise sessions completed
5 secondary outcomes
Berg Balance Scale
Time frame: baseline, 3 months, 6 months
Balance Evaluation Systems Test (BESTest)
Time frame: baseline, 3 months, 6 months
Activity-Specific Balance Confidence questionnaire
Time frame: baseline, 3 months, 6 months
30-second Sit-to-Stand Test
Time frame: baseline 3 months, 6 months
Self-reported function (PF-10)
Time frame: baseline, 3 months, 6 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 26 Apr 2023.
- 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.
Marla K Beauchamp, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home balance exercise program in people with Pulmonary Disease, Chronic Obstructive, run by McMaster University at 2 sites 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 4 inclusion and 6 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Recruitment rate (time frame: Baseline). The study lists 3 primary outcomes in all. 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 26 Apr 2023.