Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000814471
Ethics application status
Approved
Date submitted
15/06/2016
Date registered
21/06/2016
Date last updated
21/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Test reliability of the Brief-BESTest in people with chronic obstructive pulmonary disease
Scientific title
Test reliability of the Brief-BESTest in people with chronic obstructive pulmonary disease
Secondary ID [1] 289466 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 299147 0
balance 299148 0
Condition category
Condition code
Respiratory 299163 299163 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be asked to attend two assessment sessions (in addition to their routine assessment for pulmonary rehabilitation program).
- On the first assessment day, participant will be assessed by spirometry, the six-minute walk test (6MWT) and Brief-BESTest (by assessor 1). The duration of this assessment will last for 30-45 minutes.

- On the second assessment day, participant will be assessed by 6WMT (if necessary) and two Brief-BESTests which will be performed by two different assessors (by assessor 1 and assessor 2). The two assessors will perform an independent balance assessment with 15 minutes rest between tests (i.e. the participant will be assessed by two different assessors on the second assessment day with 15 minutes rest in between). The testing sequence of the assessors will be randomly assigned. All assessors are experienced therapists who are specifically trained in administering the Brief-BESTest. This assessment section will last for about 30-45minutes.

There will be a maximum of 7 days apart between the two assessment sessions.

Outcome Measures
Exercise capacity will be measured by the six-minute walk test (6MWT). Two 6MWTs will be performed and the distance walked from the better 6MWT will be used for analysis.
Fear of Falling: This will be measured by the Fall Efficacy Scale International (FES-I). The FES-I is a self-reported questionnaire providing information on level of concern about falls for a range of activities of daily living.
Balance performance: This will be measured by the brief version of the Balance Evaluation Systems Test (BESTest). The brief-BESTest is a comprehensive balance assessment tool which designed to assess six different aspects contributing to postural control in standing and walking. The test will take about 5-8 minutes to complete.
Components of the test:
1. hip lateral strength - asking participant to lift the leg sideway while keeping the trunk vertical for at least 10 seconds. Both sides will be tested.
2. functional reach test - asking the participant to reach forward as much as possible without lifting the heels. The maximum forward reaching distance will be measured.
3. single leg standing - asking participant to stand on one leg for as long as possible (a max of 20 seconds), both sides will be tested
4. compensatory lateral stepping correction - leaning into the hands of the assessor laterally, The assessor will release hands suddenly to assess compensatory skill of the participant.
5. standing on a foam with eyes closed - testing the ability of the participant to stand on a foam (AIREX balance pad) with eyes closed for a max of 30 seconds
6. timed up and go test - timing the time requires to complete the test.
Each item is scored on a 3 points scale (0 representing severe impairment and 3 representing no balance impairment) with a total score of 24 points. With items include both a right and left component, the side will score less will be included in the final score.
equipment require for the Brief-BESTest
- stop watch
- AIREX balance pad
- a chair and a walk track for timed up and go
- a tape measure or ruler for functional reach test
Lung Function: Spirometry will be measured at baseline using standard techniques. Lung function data will be used to define disease severity.
Intervention code [1] 295049 0
Early detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298648 0
The total score of the Brief-BESTest
Timepoint [1] 298648 0
after each of the three Brief-BESTest assessment
Secondary outcome [1] 324845 0
exercise capacity will be measured by the six-minute walk test (6MWT)
Timepoint [1] 324845 0
after completing the 6MWT
Secondary outcome [2] 324846 0
Fear of falling will be measured by the Fall Self-efficacy Scale (FES-I)questionnaire
Timepoint [2] 324846 0
after completing the FES-I

Eligibility
Key inclusion criteria
People will be eligible for inclusion if they have: a diagnosis of COPD (forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ratio of <0.7; a greater than 10 pack year
smoking history.
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they cannot stand without physical assistance, have comorbidities such as neurological or musculoskeletal conditions that are likely to adversely affect their balance performance during assessment, have an acute exacerbation of COPD int he last month.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
To measure the reliability of the Brief-BESTest, intra-class correlation and kappa will be used.
Sample Size: A total of 30 participants will be enrolled to the study. This is the minimum number required for employing ICC and kappa as statistics of relative agreement and will ensure that kappa and ICC values of 0.5 and larger are statistically significant at P<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/06/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5982 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 5983 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 13405 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 13406 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 293831 0
Hospital
Name [1] 293831 0
Concord Hospital
Country [1] 293831 0
Australia
Primary sponsor type
Individual
Name
Wai Man Regina Leung
Address
Concord Hospital
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 292660 0
None
Name [1] 292660 0
Address [1] 292660 0
Country [1] 292660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295258 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295258 0
Ethics committee country [1] 295258 0
Australia
Date submitted for ethics approval [1] 295258 0
02/12/2015
Approval date [1] 295258 0
11/03/2016
Ethics approval number [1] 295258 0
CH62/6/2015-021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66698 0
Dr Wai Man Regina Leung
Address 66698 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Country 66698 0
Australia
Phone 66698 0
+61297676702
Fax 66698 0
Email 66698 0
[email protected]
Contact person for public queries
Name 66699 0
Wai Man Regina Leung
Address 66699 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Country 66699 0
Australia
Phone 66699 0
+61297677602
Fax 66699 0
Email 66699 0
[email protected]
Contact person for scientific queries
Name 66700 0
Wai Man Regina Leung
Address 66700 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Country 66700 0
Australia
Phone 66700 0
+61297677602
Fax 66700 0
Email 66700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.