Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000400763
Ethics application status
Approved
Date submitted
23/12/2021
Date registered
9/03/2022
Date last updated
9/03/2022
Date data sharing statement initially provided
9/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the Responses During the Sit-to-Stand Tests with the Six-Minute
Walk Tests in Heart Failure
Scientific title
The Sit-to-Stand Test in Heart Failure: A Preliminary Observational Study
Secondary ID [1] 306023 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure with Reduced Ejection Fraction 324658 0
Condition category
Condition code
Cardiovascular 322109 322109 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exercise training is highly recommended for heart failure (HF) as it has been shown to improve exercise capacity and quality of life (QoL) and reduce hospital readmissions. Even though centre-based programmes are beneficial, poor adherence and high dropout rates, which worsened with pandemic regulations, highlight the need for developing exercise training that can be delivered remotely. The assessment of exercise capacity, both as an outcome and for exercise prescription, remains essential to any program. While the six-minute-walk test (6MWT) remains the gold standard, the ability to perform this test remotely remains problematic. Sit to stand tests (STST), such as the 60 second sit-to-stand test (STST-60) and 30 second sit-to-stand tests (STST-30) are another measure of exercise capacity in HF that are currently underutilised. The STST can be easily performed in the home and monitored remotely, but has not been studied or compared with the six-minute walk test in people with HF.
Purpose: To examine and compare the physiological and non-invasive haemodynamic responses to the STST (1 minute and 30s) and the six-minute walk test in 25 stable HF patients.
Methods: An experienced physiotherapist will identify potential patients and then email a physiotherapy honours student. The honours student will ring those participants to organise a time to come. Each participant will attend the laboratory at Griffith University on the Gold Coast on three separate occasions. Participants will be seen one-on-one and each session will be conducted by an experienced physiotherapist/exercise physiologist and a physiotherapy honours student. During the first visit the participant will be familiarised with all procedures and complete measurements of lower limb quadriceps strength and body composition using Dual X-Ray Absorptiometry (DEXA). On the next two experimental visits the participant will complete either two 6MWT or two STST (a 1min-STST and a STST-30). The two tests each visit will be conducted approximately 30 minutes apart. During one of the 6MWT and during both of the STST pulmonary gas exchange will be measured using a portable metabolic system (Metamax, Cortex BXB, Leipzig, GER). Each visit will be approximately one-hour in duration and experimental visits will be approximately one week apart. Approximately 2 days after the experimental visits, each participant will be contacted via telephone regarding the onset of any muscle soreness.
Intervention code [1] 322449 0
Early Detection / Screening
Comparator / control treatment
Comparator: 6MWT
Field walking tests are widely used in chronic respiratory disease to measure exercise capacity, therapeutic response and prognosis. Recently 6MWT are increasingly employed in heart failure population as well. Other most common field walking tests include the 6MWT, the incremental and endurance shuttle walk test. The 6MWT is the most commonly used measure of exercise capacity in clinical practice. The test requires individuals to walk briskly up and down a 30-metre corridor, and is a simple to perform, well-tolerated, safe and more representative of ordinary activities than other similar walking tests. The 6MWT assesses the integrative exercise response as it requires the coordination of the cardiovascular, skeletal muscle and pulmonary systems during the exercise challenge. The 6MWT has been used to demonstrate increased exercise capacity.
Control group
Active

Outcomes
Primary outcome [1] 329897 0
Assessments of Physiological Responses:
Physiological data i.e., pulmonary gas exchange will be measured using a portable metabolic system (Metamax, Cortex BXB, Lepzig, Germany). The system will be calibrated for volume and expired gas concentrations prior to each test. The following data will be collected: oxygen consumption (VO2), carbon dioxide production (VCO2), ventilation (VE), Respiratory exchange ratio(RER), heart rate (HR), Dyspnoea (modified 0-10 Borg Scale), oxygen saturation (SpO2: RAD-5v Masimo Corp, Irvine, CA, USA) and blood pressure (mercurial sphygmomanometer). This is a composite primary outcome measure.
Timepoint [1] 329897 0
All data will be collected continuously during sit to stand tests and 6 minute walk test. Primary time points will be immediately pre-exercise and at the end of exercise. The highest VO2, VCO2, VE, RER, HR and Dypsnoea and the lowest SpO2 recorded immediately post exercise will be designated the post-exercise data.
Primary outcome [2] 329936 0
Assessments of Non-invasive Haemodynamic Responses:
Non-invasive haemodynamic data will be collected using impedance cardiography (PhysioFlow, Manatec Biomedical, Paris, France) and blood pressure measurements . This device will allow for the measurement of cardiac output (Q), stroke volume (SV) and enable arteriovenous oxygen difference to be derived through the Fick Equation. This is a composite primary outcome measure.
Timepoint [2] 329936 0
All data will be collected continuously during sit to stand tests and 6 minute walk test. Primary time points will be immediately pre-exercise and at the end of exercise. The highest Q, SV and arteriovenous oxygen difference recorded immediately post exercise will be designated the post-exercise data.
Secondary outcome [1] 404344 0
Assessment of Delayed onset muscle soreness (7 point Likert scale). Participants will be contacted by one of the investigators over the phone and asked to rate their muscle soreness. This is a composite primary outcome.
Timepoint [1] 404344 0
Assessed 24-48 hours following the the 6MWT or STST visit to the laboratory.
Secondary outcome [2] 406090 0
Lower Limb Muscle Strength
-Quadriceps muscle isometric and isokinetic strength will be assessed using the Biodex system (System 4, Biodex Medical Systems, Shirley NY, USA).
Timepoint [2] 406090 0
During the familarisation visit. Data used to characterise participants included in the study.
Secondary outcome [3] 406091 0
Body Composition
-To evaluate lower limb lean muscle, a Dual XRay Absorptiometry (DEXA) scan will be performed by a trained DEXA operator in accordance with the DEXA protocol
Timepoint [3] 406091 0
During the familarisation visit. Data used to characterise participants included in the study.
Secondary outcome [4] 406092 0
Quality of Life (QoL)
-Changes in quality of life will be assessed using outcome measures previously validated in the literature. The Kansas City Cardiomyopathy Questionnaire is a 12- item self-administered questionnaire for quantifying health-related QoL
Timepoint [4] 406092 0
During the familarisation visit. Data used to characterise participants included in the study.

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they have Heart Failure (HF) of any cause confirmed by echocardiography in preceding 12 months, and have been referred or completed a HF rehabilitation program.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Participants deemed unsafe to exercise on the day of assessment according to American College of Sports Medicine (ACSM) and Australian guidelines

-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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
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 local Health Precinct. As all people referred for HF rehabilitation undergo
stringent safety review prior to being accepted into the programme and will have undertaken both a six minute walk test and a sit to stand test as part of their rehabilitation program, no further safety criteria will be required. We aim to recruit 25 participants for this study, which is based on the sample size of previous similar studies.

Data analysis: Participant characteristics will be summarised using descriptive statistics. Differences in end exercise physiological/haemodynamic responses will be compared using a paired t-test. For data which is not normally distributed, differences will be compared using the Mann Whitney U test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 21346 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 36237 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 310735 0
University
Name [1] 310735 0
Griffith University
Country [1] 310735 0
Australia
Primary sponsor type
University
Name
Griffith University - School of Health Csiences
Address
Griffith University Goldcoast Campus: 1 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 311549 0
None
Name [1] 311549 0
Address [1] 311549 0
Country [1] 311549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310019 0
The Griffith University Human Research Ethics Committee
Ethics committee address [1] 310019 0
1 Parklands Dr, Southport QLD 4215
Ethics committee country [1] 310019 0
Australia
Date submitted for ethics approval [1] 310019 0
17/06/2021
Approval date [1] 310019 0
01/07/2021
Ethics approval number [1] 310019 0
GU Ref No: 2021/451

Summary
Brief summary
The overall aim of the study is to examine and compare the physiological and non-invasive
haemodynamic responses during the sit-to-stand test in one-minute (1min-STST) and the six-minute walk test (6MWT) in individuals with stable heart failure with reduced ejection fraction

In addition, there are several objectives that are to be examined in this study. The first objective would be to examine and compare the physiological/non-invasive haemodynamic
responses during the 1min-STST with the 6MWT in HFrEF patients. The corresponding hypothesis is that the 1min-STST will generate similar physiological/non-invasive
haemodynamic responses to that achieved during the 6MWT. In contrast, the null hypothesis is that 1min-STST will generate a significantly different physiological noninvasive haemodynamic responses to that achieved during the 6MWT.

Objective 2: To determine the relationship between quadriceps muscle strength and lower limb lean muscle mass and the 1min-STST performance and physiological/non-invasive
haemodynamic responses.
Hypothesis 2: Greater lower limb muscle strength and higher skeletal muscle mass will be
positively related to the 1min-STST performance and physiological/non-invasive
haemodynamic responses i.e., those individuals with the greatest skeletal muscle mass and
strength will perform a greater number of sit-to-stand (STS) activities in 1-minute.
Null Hypothesis 2: There will be no significant relationship between lower limb muscle
strength/skeletal muscle mass and the 1min-STST performance and physiological/non-invasive haemodynamic responses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116202 0
Prof Norman Morris
Address 116202 0
Griffith University: 1 Parklands Dr, Southport QLD 4215
Country 116202 0
Australia
Phone 116202 0
+61 411562055
Fax 116202 0
Email 116202 0
[email protected]
Contact person for public queries
Name 116203 0
Prof Norman Morris
Address 116203 0
School of Health Sciences and Social Work
The Menzies Health Institute
Griffith University
1 Parklands Dr, Southport QLD 4215

Professor of Physiotherapy, Cardiothoracic
Metro North Hospital and Health Service, The Prince Charles Hospital. Allied Health Research Collaborative
Queensland, Australia
Country 116203 0
Australia
Phone 116203 0
+61 411562055
Fax 116203 0
Email 116203 0
[email protected]
Contact person for scientific queries
Name 116204 0
Prof Norman Morris
Address 116204 0
School of Health Sciences and Social Work
The Menzies Health Institute
Griffith University
1 Parklands Dr, Southport QLD 4215

Professor of Physiotherapy, Cardiothoracic
Metro North Hospital and Health Service, The Prince Charles Hospital. Allied Health Research Collaborative
Queensland, Australia
Country 116204 0
Australia
Phone 116204 0
+61 411562055
Fax 116204 0
Email 116204 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?
De identified participant data collected during the study.
When will data be available (start and end dates)?
Immediately following the publication, no end date.
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose, only for the achievement of the aims in the approved proposal
How or where can data be obtained?
Access subject to approval of the Principal Investigator.
Prof Norman Morris
School of Health Sciences and Social Work
The Menzies Health Institute
Griffith University
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14452Study protocol    383286-(Uploaded-15-12-2021-18-57-39)-Study-related document.docx
14455Informed consent form    383286-(Uploaded-15-12-2021-18-59-16)-Study-related document.docx



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.