Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000030471
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
18/01/2016
Date last updated
6/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of changes to balance during walking with exertion in adults with chronic obstructive pulmonary disease
Scientific title
Pilot study investigating changes in balance control during walking with exertion in adults with chronic obstructive pulmonary disease
Secondary ID [1] 288315 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural balance 297285 0
Condition category
Condition code
Neurological 297477 297477 0 0
Other neurological disorders
Respiratory 297517 297517 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Each participant will attend for two testing sessions one week apart (washout). Attendance of total duration two hours (ie one hour each session) with no follow up. At each session one of the two walking tests will be undertaken. Test order will be allocated randomly (computer generated by an independent researcher and numbers provided to research team in opaque envelopes). the two test are;
1. Shuttle Walk Test
A standardised externally paced incremental field walking task that provokes a symptom limited maximal performance
Used to assess functional capacity in people with chronic airways obstruction
One test is required for learning then a repeat test for assessment
The participant is required to walk between two cones in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The participant walks for as long as they can until they are either too breathless or can no longer keep up with the beeps at which time the test ends. The period of
A one-week washout period separates the two tests
2. 6 Minute Walk Test
This is a sub maximal test with normative data developed for community dwelling older adults
Used as a performance measure of gait endurance
Two tests within 30 minutes are required for validity
The object of this test is to walk as quickly as possible for six minutes between two markers so that the participant can cover as much ground as possible. The participant may slow down if necessary or stop. The participant may recommence walking again as soon as possible until the full 6 minute duration has elapsed
Intervention code [1] 293610 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297042 0
Gait regularity: The GAITRite sensor mat and software will be utilised to capture:
­ Stride-time variability
­ Walking Velocity (distance and time analysis)
­ Step length variability
­ Step width variability
­ Double-support phase
Timepoint [1] 297042 0
During the single assessment shuttle walk test as well as the two 6 minute walk tests.
Primary outcome [2] 297043 0
Dynamic balance measured using Functional reach. It is a performance measure which identifies forwards reach ability in bilateral stance (self-generated perturbation) using continuous ratio data
This measure will be performed before and after each intervention to identify a change in dynamic balance after exertional walking
Timepoint [2] 297043 0
Before and after the shuttle walk test and the two 6 minute walk tests (ie 6 time points)
Secondary outcome [1] 319906 0
Level of exertion measured using both the modified Borg dyspnea scale and oxygen saturation levels, heart rate and respiratory rate by capnograph
Timepoint [1] 319906 0
Throughout the single assessment shuttle walk test as well as the two 6 minute walk tests

Eligibility
Key inclusion criteria
1. People with a confirmed diagnosis of COPD (as determined by a lung function test)
2. Adults (18 years and over) able to provide informed consent to participate in the study
3. A current or recent participant of Pulmonary Rehabilitation at the UTAS, Launceston Campus
4. Able to ambulate independently on a flat even surface to complete the test safely
5. Living at home with or without oxygen supplementation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People with end stage COPD that are requiring palliative management
2. People with a self-reported acute infective exacerbation in their symptoms
3. People that require a gait aid, a prosthetic limb, or physical assistance to walk
4. People with a significant neurological condition that affects their gait regularity
5. Women who are pregnant

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To determine if gait regularity is affected by exertional walking:
Gait regularity will be analysed using linear regression modelling for within task and between task comparisons. If the residuals from linear modelling do not meet the requirements of linear regression then data will be analysed using logistic regression. A paired T test will be used to compare functional reach prior to and after each of the exertional tasks. Covariance accounting for baseline values will be undertaken.

To determine if dynamic balance is affected by exertional walking:
Functional reach will be measured before and after each exertional task and within task differences will be measured using paired t test

Correlation analysis will be undertaken to assess the relationship between changes to gait regularity and measures of exertion including oxygen saturation and heart rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2016
Actual
16/07/2016
Date of last participant enrolment
Anticipated
7/03/2017
Actual
19/01/2017
Date of last data collection
Anticipated
Actual
19/01/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 292687 0
University
Name [1] 292687 0
University of Tasmania
Country [1] 292687 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Newnham Drive, Newnham, Tasmania 7250
Country
Australia
Secondary sponsor category [1] 291409 0
None
Name [1] 291409 0
None
Address [1] 291409 0
None
Country [1] 291409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294159 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 294159 0
Ethics committee country [1] 294159 0
Australia
Date submitted for ethics approval [1] 294159 0
06/11/2015
Approval date [1] 294159 0
17/12/2015
Ethics approval number [1] 294159 0
H0015372

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

Contacts
Principal investigator
Name 62738 0
Dr Marie-Louise Bird
Address 62738 0
The School of Health Science,
University of Tasmania,
Locked Bag 1322, Launceston, Tasmania, 7250,
Country 62738 0
Australia
Phone 62738 0
+61 3 63245497
Fax 62738 0
Email 62738 0
[email protected]
Contact person for public queries
Name 62739 0
Marie-Louise Bird
Address 62739 0
The School of Health Science,
University of Tasmania,
Locked Bag 1322, Launceston, Tasmania, 7250,
Country 62739 0
Australia
Phone 62739 0
+61 3 63245497
Fax 62739 0
Email 62739 0
[email protected]
Contact person for scientific queries
Name 62740 0
Marie-Louise Bird
Address 62740 0
The School of Health Science,
University of Tasmania,
Locked Bag 1322, Launceston, Tasmania, 7250,
Country 62740 0
Australia
Phone 62740 0
+ 61 3 63245497
Fax 62740 0
Email 62740 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.