Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001096943
Ethics application status
Approved
Date submitted
30/07/2020
Date registered
21/10/2020
Date last updated
21/10/2020
Date data sharing statement initially provided
21/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, Reliability and Validity of Sit to Stand Tests in People with Heart Failure
Scientific title
Feasibility, Reliability and Validity of Sit to Stand Tests as an assessment of exercise capacity in People with Heart Failure
Secondary ID [1] 301881 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Heart failure 318381 0
Condition category
Condition code
Cardiovascular 316400 316400 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 317171 317171 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective cohort study will be undertaken to determine feasibility, reliability and responsiveness to change of two commonly used variations of the sit to stand test (STST-5 and STST-60) in people with heart failure (HF) enrolled in an exercise training programme.
The sit-to-stand test (STST) is a short-duration test, frequently used in rehabilitation settings as a measure of balance and mobility. Several variations of the test exist, all of which require individuals to repetitively move from sitting to standing for different durations. Being a functional activity and easy to administer in any setting, the STST has been proposed as a viable option for assessment of exercise capacity in people with HF. Whilst it has been used as a measure of improved performance for people with HF undergoing an exercise training programme, reliability and validity in this population is yet to be determined.
The relationship of these two STSTs with other measures traditionally collected at the baseline assessment will also be assessed.

Eligible participants will be identified by the Physiotherapist associated with the HF exercise programme at each of the participating sites and will be provided with written and verbal information about the study. Consenting participants will undergo their usual assessments at baseline and follow-up (week 13) which include performance of a 6MWT and Timed up and go test (TUGT), however will also complete two STSTs, adding approximately 15 minutes to the assessment duration.
Participants will attend their 12 week HF exercise rehabilitation programme as planned at their respective health facility. This is a 12 week, centre-based, group exercise programme, whereby individuals attend weekly for 1 hour of exercise training, supervised by the HF Physiotherapist and nurse. Eligible participants who choose not to participate in the study will attend the exercise training programme as per usual practice, however will not have the STSTs included in their baseline and follow-up assessments.
For participants, measures will be conducted by the investigator at each site. All investigators are experienced Physiotherapists very familiar with these test procedures. Due to the number of STSTs involved and consequent potential for fatigue, the order of the two STSTs tests will be randomised at baseline and follow-up for each participant.

STST-5: In this test, participants will be asked to complete the test procedure five times. A stopwatch will be used to record the time elapsed until the participant is fully sitting following the fifth stand. The time required to complete the test will be recorded in seconds to two decimal places.
STST-60: In this test, the participant is asked to complete the procedure for 60 seconds whilst the assessor silently counts the number of complete stands during this time. Incomplete attempts will not be counted, except on the final stand, when the attempt will be counted if the participant is greater than halfway up.
Blood pressure will be measured in sitting at completion of the two performances of each STST.

Because we aim to investigate feasibility of performing the STST in the home environment, participants at one site will perform the two STSTs in their homes with the Physiotherapist (based at the health facility), supervising via a Telehealth video link. These Telehealth appointments for performance of the STST (baseline and follow-up) will be scheduled at a time that is suitable for participants and assistance will be provided to those not familiar with the technology. It is anticipated that these appointments will take less than 30 minutes. All other measures for the baseline and week 13 assessments will be conducted as usual at the health facility.
Intervention code [1] 318172 0
Diagnosis / Prognosis
Comparator / control treatment
This is an multicentre, prospective, observational study with only one population (Ie people with HF attending an exercise rehabilitation programme.

The STST will be validated in this population and results correlated with the 6MWT. There is no control group.
Control group
Active

Outcomes
Primary outcome [1] 324555 0
Test-retest reliability of the STST-5 will be assessed by the HF Physiotherapist at each participating site.
Timepoint [1] 324555 0
Assessments will be conducted at baseline and 12 week follow up as part of the usual assessments for people attending a HF exercise training programme
Primary outcome [2] 324928 0
Test-retest reliability of the STST-60s will be assessed by the HF Physiotherapist at each participating site.
Timepoint [2] 324928 0
Assessments will be conducted at baseline and following the 12 week exercise programme (week 13) part of the usual assessments for people attending a HF exercise training programme
Secondary outcome [1] 384962 0
Feasibility of STSTs for people with HF attending an exercise training programme will be determined by:

• Proportion of eligible participants unable to complete the STST according to protocol but able to complete a modified version of the respective test
• Proportion of eligible participants unable to complete the STST according to protocol and a modified version of each test
• Proportion of participants excluded from the study on the basis of postural hypotension
Timepoint [1] 384962 0
single assessment determined at completion of the study duration for each participant (Ie week 13, one week after 12 week exercise programme)
Secondary outcome [2] 384963 0
Responsiveness of the STST most closely associated with 6MWT (STST-5 or STST-30s), to a 12-week exercise-based rehabilitation program by measuring change in STST between follow-up (13 weeks) and baseline.
Timepoint [2] 384963 0
STSTs will be measured at baseline prior to commencing the HF exercise programme, and again at week 13 (following completion of the HF exercise programme).
Secondary outcome [3] 387338 0
Six minute walk test (6MWT)
The test will be performed according to recommended procedure on a 30-metre track with standard encouragement provided every minute. Participants will be instructed to walk at their own pace whilst attempting to cover the greatest distance possible during the six minutes. Blood pressure will be collected pre- and post-test and whilst heart rate and oxygen saturation will be monitored continuously throughout. To account for a learning effect, the test will be performed twice at baseline and once at follow-up. Tests will be sufficiently spaced to allow full recovery between tests.
Timepoint [3] 387338 0
Baseline and week 13
Secondary outcome [4] 387339 0
Timed Up and Go Test (TUGT)
The tests commences with participants in a seated position. Upon command from the assessor, participants then stand, walk three metres, turn around, walk back to the chair and sit down. The time taken to complete the task is measured in seconds to two decimal places. For participants who require a walking aid, this same aid is used for all repeat tests. Two TUGTs will be conducted at baseline and follow-up (week 13), with the best result (shortest time) used for the analysis.
Timepoint [4] 387339 0
Baseline and week 13
Secondary outcome [5] 387340 0
Adverse events
Feasibility will also be determined using adverse events. These will be documented by the assessor in the event of occurrence, at the time of either baseline or follow-up assessment.
Adverse events will be. defined as any of the following:
- dizziness, syncope, falls
- persistent symptoms which don’t resolve immediately upon rest such as shortness of
breath requiring oxygen, low blood pressure requiring the individual to lie supine or any
symptom requiring medical review or hospitalisation
- chest pain,
- worsening musculoskeletal pain
• reason for non-completion of the STST such as dizziness, fatigue, musculoskeletal pain
Timepoint [5] 387340 0
Baseline and week 13

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they have HF of any cause confirmed by echocardiography in preceding 12 months, and are enrolled in a HF exercise training programme at one of the participating sites. As all people referred for HF rehabilitation undergo stringent safety review prior to being accepted into the programme, no further safety criteria will be required.

Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Participants deemed unsafe to exercise on the day of assessment according to American College of Sports Medicine (ACSM) and Australian guidelines.
• Symptomatic postural hypotension, defined by dizziness in the presence of a reduction in systolic BP by 20mmHg or more upon standing from a seated position
• Orthopaedic or neurological conditions which preclude performance of any of the proposed exercise tests
• Severe cognitive, language and psychological condition that precludes participation in the exercise tests

For participants at the Princess Alexandra Hospital who will perform the STSTs in the home environment, addition exclusion criteria will include:
• Deemed unsafe to perform a STST in the home environment based upon medical condition, risk of falling or need for supervision to be present
• Inability to participate in a telehealth consult due to lack of or poor usability of technology, poor vision or poor hearing

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant characteristics will be summarised using descriptive statistics. Feasibility will be reported according to the proportion of participants unable to complete either of the STSTs according to protocol or a modified version of the test. The number of adverse events will also be reported. Intra-class correlation coefficient (ICC) will be used to determine test-retest reliability and correlations for relationships with other variables. The strength of reliability will be interpreted where excellent was > 0.9. Standard error of measurement (SEM) and minimal detectable change at 95% confidence interval (MDC95) will be calculated. A Bland and Altman’s plot will also be presented to visually examine the trends and agreements between the two test retests. Relationships between the STST and TUGT and 6MWT will be examined using scatter plots, and Pearson’s (r) or Spearman’s (rs) correlations as appropriate. Mann-Whitney’s test will be used to determine differences in dichotomous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2020
Actual
Date of last participant enrolment
Anticipated
12/03/2021
Actual
Date of last data collection
Anticipated
28/05/2021
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17148 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 17149 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 17150 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 17151 0
Gold Coast University Hospital - Southport
Recruitment hospital [5] 17152 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 30828 0
4029 - Herston
Recruitment postcode(s) [2] 30829 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 30830 0
4032 - Chermside
Recruitment postcode(s) [4] 30831 0
4215 - Southport
Recruitment postcode(s) [5] 30832 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 306301 0
Government body
Name [1] 306301 0
Directors of Physiotherapy Services Queensland grant
Country [1] 306301 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston 4029
Brisbane
Queensland
Country
Australia
Secondary sponsor category [1] 306794 0
None
Name [1] 306794 0
Address [1] 306794 0
Country [1] 306794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306516 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 306516 0
Royal Brisbane and Women's Hospital
James Mayne Building
Butterfield St, Herston 4029
Brisbane
Queensland
Ethics committee country [1] 306516 0
Australia
Date submitted for ethics approval [1] 306516 0
27/07/2020
Approval date [1] 306516 0
31/08/2020
Ethics approval number [1] 306516 0
LNR/ 2020/ QRBW/ 66520

Summary
Brief summary
This study is being undertaken to assess whether a test, known as the sit to stand test (STST) is a useful measure of fitness for people with heart failure (HF). Participants enrolled in a HF exercise programme, will perform two versions of the test (the STST-5 and STST-60s) as part of their baseline and completion assessments. Results will be compared to usual measures of fitness. The study will also determine whether the test is able and reliably performed by people with HF, not only at the health facility, but when also in the home environment when supervised remotely.
Results of this study will be used to influence how HF exercise programmes are delivered in the home environment, potentially reducing the need for appointments at the health facility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104130 0
Dr Julie Adsett
Address 104130 0
Heart Support Service
Royal Brisbane and Women's Hospital
Butterfield St
Herston 4029
Brisbane
Queensland
Country 104130 0
Australia
Phone 104130 0
+61 7 3646 0286
Fax 104130 0
+61 7 3646 0272
Email 104130 0
[email protected]
Contact person for public queries
Name 104131 0
Dr Julie Adsett
Address 104131 0
Heart Support Service
Royal Brisbane and Women's Hospital
Butterfield St
Herston 4029
Brisbane
Queensland
Country 104131 0
Australia
Phone 104131 0
+61 7 3646 0286
Fax 104131 0
+61 7 3646 0272
Email 104131 0
[email protected]
Contact person for scientific queries
Name 104132 0
Dr Julie Adsett
Address 104132 0
Heart Support Service
Royal Brisbane and Women's Hospital
Butterfield St
Herston 4029
Brisbane
Queensland
Country 104132 0
Australia
Phone 104132 0
+61 7 3646 0286
Fax 104132 0
+61 7 3646 0272
Email 104132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only de-identified data will be available for sharing including:
- Participant characteristics - age, gender, left ventricular ejection fraction, HF phenotype, NYHA functional classification, co-morbidities (including musculoskeletal conditions which may impact on the ability to perform the tests), presence of musculoskeletal pain and medications
- 6MWT
- TUGT
- STST data
- adverse events
When will data be available (start and end dates)?
Data will be available at completion of the study. There will be no end date for availability of data.
Available to whom?
Data will only be shared by members of the research team.
Additionally enquiries from external researchers will be discussed by the research team and if agreed, deidentified data will be shared
Available for what types of analyses?
Data will be available for evaluation of programme attendance, and physiological responses to STST (eg BP)
How or where can data be obtained?
All external enquiries will formally seek permission to access de-identified data through the Chief Investigator. Contact will be via the Chief Investigator's email:
[email protected]


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.