Chronic Obstructive Pulmonary DiseaseNCT02080442
Balance Training for Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Samantha Harrison at 1 site in Canada.
Trial summary
The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Balance training
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Feb 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COPD enrolled in PR
Who may be able to join
- Diagnosis of COPD
- Self-report of decline in balance or fall in the last 5 years or a recent near fall
- Smoking history greater than 10 pack years
- Are able to provide written informed consent.
Who cannot join
- An inability to communicate because of language skills, hearing or cognitive impairment
- Evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Training for COPD in Pulmonary Rehabilitation (PR): An Effectiveness Study
The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Balance training
- Keywords
- COPD, Balance, Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
Training will consist of 30 minute sessions 2-3 times/week for a total of 18-24 sessions, in keeping with best practice guidelines for older adults.12 Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Not described Receives: Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
The BBS was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
Measured: at 6 weeks
Timed Up and Go (TUG):
The TUG was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
Measured: at 6 weeks
Secondary outcomes (2)
The Balance Evaluation Systems Test (BESTest)
The BESTest was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
Measured: at 6 weeks
Activity-specific Balance Confidence (ABC) Scale
The ABC scale was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samantha Harrison
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association
- Responsible party
- Sponsor-investigator, Samantha Harrison, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080442
- Sponsor's protocol ID
- 13-o11-WP
- Status last verified
- Mar 2014
- First submitted
- 3 Mar 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
Publications
Harrison SL, Beauchamp MK, Sibley K, Araujo T, Romano J, Goldstein RS, Brooks D. Minimizing the evidence-practice gap - a prospective cohort study incorporating balance training into pulmonary rehabilitation for individuals with chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Jul 23;15:73. doi: 10.1186/s12890-015-0067-2.
PubMed 26202647
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Training for COPD in Pulmonary Rehabilitation (PR): An Effectiveness Study
- ClinicalTrials.gov ID
- NCT02080442
- Acronym / sponsor ID
- 13-o11-WP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Balance, Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Samantha HarrisonUniversity, hospital or other
- Collaborators
- Ontario Lung Association
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Mar 2014 (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.
The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | Other: Balance training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COPD enrolled in PR
Key inclusion criteria (4 listed)
- Diagnosis of COPD
- Self-report of decline in balance or fall in the last 5 years or a recent near fall
- Smoking history greater than 10 pack years
- Are able to provide written informed consent.
Key exclusion criteria (2 listed)
- An inability to communicate because of language skills, hearing or cognitive impairment
- Evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).
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 |
|---|---|---|
| Balance trainingTraining will consist of 30 minute sessions 2-3 times/week for a total of 18-24 sessions, in keeping with best practice guidelines for older adults.12 Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression. | Other | Chronic Obstructive Pulmonary Disease |
Primary outcome
Berg Balance Scale (BBS)
Time frame: at 6 weeks
The BBS was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
Timed Up and Go (TUG):
Time frame: at 6 weeks
The TUG was assessed following completion of the balance training which took place thrice weekly for a period of 6 weeks.
2 secondary outcomes
The Balance Evaluation Systems Test (BESTest)
Time frame: at 6 weeks
Activity-specific Balance Confidence (ABC) Scale
Time frame: at 6 weeks
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 6 Mar 2014.
- Derived from this study: PubMed 26202647Harrison SL, Beauchamp MK, Sibley K, Araujo T, Romano J, Goldstein RS, Brooks D. Minimizing the evidence-practice gap - a prospective cohort study incorporating balance training into pulmonary rehabilitation for individuals with chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Jul 23;15:73. doi: 10.1186/s12890-015-0067-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Samantha Harrison 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 4 inclusion and 2 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 6 Mar 2014. 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?
Berg Balance Scale (BBS) (time frame: at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080442, which also lists 1 linked publication.
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 6 Mar 2014.