Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000134729
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
27/01/2022
Date last updated
27/01/2022
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an online exercise program on fitness and blood pressure in people with high blood pressure
Scientific title
Investigating feasibility and efficacy of a virtual UNSW Lifestyle Clinic exercise physiologist intervention for people with hypertension: a pilot randomised controlled trial
Secondary ID [1] 306072 0
Nil known
Universal Trial Number (UTN)
U1111-1271-5598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 324718 0
Condition category
Condition code
Public Health 322164 322164 0 0
Health promotion/education
Physical Medicine / Rehabilitation 322165 322165 0 0
Other physical medicine / rehabilitation
Cardiovascular 322302 322302 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Feasibility and efficacy of a virtual exercise physiologist intervention for people with hypertension
- Physical or informational materials: No physical materials will be provided, personalised information about exercise will be delivered during the exercise sessions. The exercise component will be evidence-based as per American College of Sports Medicine guidelines, a combination of aerobic, resistance, balance and flexibility exercises such as brisk walking/jogging (indoor or outdoor), or step-up will be prescribed as is suitable and relevant to the participant.

- procedures: Once all baseline data collection is completed, participants will be randomly allocated into the intervention or control groups. Participants in the intervention group will be connected with an Accredited Exercise Physiologist (AEP) at UNSW lifestyle clinics to provide online consultations. AEPs will have a current accreditation issued by the regulatory body Exercise and Sports Science Australia (ESSA) as well as a current Medicare provider number for the UNSW Lifestyle Clinic. The intervention group will receive 7 online consultations using Microsoft Team or UNSW Zoom platform at participants' preferred time and premises (e.g. their home or other location with an internet connection) over the 12-week intervention period. During these consultations, participants will be taught techniques to increase their physical activity level based on their capability and their initial physical activity level.

- who will deliver the intervention: AEPs with a current accreditation issued by the regulatory body Exercise and Sports Science Australia (ESSA) as well as a current Medicare provider number for the UNSW Lifestyle Clinic.

- the mode of delivery: Online using teleconferencing tools such as Zoom or Microsoft Team individually

- the number of times the intervention will be delivered and over what period of time including the number of sessions, their schedule: Overall, 7 sessions x 1 hour each over 12 weeks will be delivered weekly for the first month, then fortnightly and monthly in the second and third months of the intervention.

- the location where the intervention occurs: Online at participants' preferred premises (e.g. their home)

- personalised intervention: The AEP will provide online personalised exercise consultations. During these consultations, participants will be taught techniques to increase their physical activity level based on their capability and their initial physical activity level. The exercise advice will be evidence-based as per American College of Sports Medicine guidelines, a combination of aerobic, resistance, balance and flexibility exercises will be prescribed as is suitable and relevant to the participant.

Intervention adherence and fidelity: Adherence will be assessed by calculating the retention rate for the study (i.e. number of participants completed all aspects of study/ number of participants consented). Further performance will be monitored as follows. At the beginning of each session, the AEP will follow up with participants on their performance since the last session. At the end of each session, participants will set a specific goal to be completed based on their capability and their physical activity level (e.g. a set of exercises to be completed every other day). Participants will be asked to share their performance by specifying the percent of tasks completed between each session.

Strategies to improve fidelity: Participants will be reimbursed for their participation by means of a shopping gift voucher to the value of $100. The reimbursement/reward will be provided to participants who complete all aspects of the study. Participants who attend the focus group interview will receive an additional shopping gift voucher valued at $50 as an incentive.
Intervention code [1] 322475 0
Lifestyle
Intervention code [2] 322568 0
Treatment: Other
Comparator / control treatment
Procedure: The control group will receive usual care (receiving their usual care from their own GP or specialist with no additional care delivered by the research team) and 2 short phone calls at Weeks 4 and 8 from an accredited exercise phyisologist (but no exercise advice) to check on their welfare and any adverse events to ensure both groups receive attention and safety measures.
Duration: 2 sessions x 5 minutes phone call over 12 weeks
Control group
Active

Outcomes
Primary outcome [1] 329941 0
Participants experience with the intervention by a qualitative focus group interview using a semi-structured interview guide. Interviews will be video and audio recorded and transcribed verbatim. Only the voice record will be stored after the completion of the study. Each focus group will take approximately 60-90 minutes for the intervention group and 30-60 minutes for the control group with 4-8 participants at each session.
Timepoint [1] 329941 0
Follow up at Weeks 13- 16 (i.e. up to 4 weeks after 12-week intervention)
Primary outcome [2] 329942 0
Satisfaction using a 5-point rating scale ranging from strongly disagree to strongly disagree.
Timepoint [2] 329942 0
Follow up at Week 12 (i.e. 12-week post-intervention commencement)
Primary outcome [3] 329944 0
Feasibility assessed as the retention rate determined by the audit of the study database
Timepoint [3] 329944 0
At the conclusion of study
Secondary outcome [1] 404366 0
Standard cuff-based blood pressure assessment measured using Aktiia Bluetooth cuff (SA, Switzerland) device
Timepoint [1] 404366 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [2] 404367 0
Continuous 24-hour blood pressure over 7 consecutive days measured by Aktiia cuffless wrist-based (SA, Switzerland) device
Timepoint [2] 404367 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [3] 404368 0
Resting heart rate measured by Aktiia cuffless wrist-based (SA, Switzerland) device
Timepoint [3] 404368 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [4] 404369 0
Self-report weight
Timepoint [4] 404369 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [5] 404370 0
Self-report physical activity level using a validated questionnaire (Active Australia Survey)
Timepoint [5] 404370 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [6] 404371 0
2-minutes step tests facilitated by accredited exercise physiologist online
Timepoint [6] 404371 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [7] 404385 0
Number of sessions participants completed by the audit of study database
Timepoint [7] 404385 0
Throughout the intervention
Secondary outcome [8] 404796 0
Percent of tasks completed between each session: At the beginning of each session, the AEP will follow up with participants on their performance since the last session. At the end of each session, participants will set a specific goal to be completed based on their capability and their physical activity level (e.g. a set of exercises to be completed every other day). Participants will be asked to share their performance by specifying the percent of tasks completed between each session.
Timepoint [8] 404796 0
Throughout the intervention
Secondary outcome [9] 404797 0
5 times sit to stand test facilitated by accredited exercise physiologist online
Timepoint [9] 404797 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [10] 404798 0
Self-report waist circumference
Timepoint [10] 404798 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [11] 404799 0
Self-report hip circumference
Timepoint [11] 404799 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [12] 404800 0
self-report height
Timepoint [12] 404800 0
Baseline at Week 0 (a week prior to 12 week-intervention)
Secondary outcome [13] 404853 0
User experience using a scale partially adapted from System Usability Scale (SUS, Brooke 1986.)
Timepoint [13] 404853 0
Follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [14] 404854 0
Perception and use of the local residential environment for exercise using multiple-choice questions. Questions such as how often participants use the residential green or blue space for physical activity purposes.
Timepoint [14] 404854 0
Baseline at Week 0 (a week prior to 12 week-intervention) and follow up at Week 12 (i.e. 12-week post-intervention commencement)
Secondary outcome [15] 405385 0
Missing data rate for the device, and number of days that the device was not worn.
Timepoint [15] 405385 0
At the end of study

Eligibility
Key inclusion criteria
• be 18 years of age or older;
• diagnosed with hypertension and recent clinic systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg;
• willing to wear wrist-based blood pressure device for seven consecutive days at baseline and after 3 months;
• willing to undergo initial exercise tests by an Exercise Physiologist to determine eligibility;
• have access to a smartphone and the internet and feel comfortable to use it to download an App for use with a blood-pressure device, complete online assessments, and join online video consultations with an Accredited Exercise Physiologist;
• no plan to change medications;
• have a personal weighing bathroom scale; and
• independently ambulant for 200m (be confident to walk 200m or around the block unassisted).

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• significant alcohol or drug use;
• pregnancy (or planned pregnancy);
• unstable cardiovascular, respiratory and neurological disorders; established chronic kidney disease (eGFR <60ml/kg/1.73m2); known arrhythmias (irregular heart rhythms); known vascular aneurysm; implanted electrical devices (e.g. cardiac pacemakers or defibrillators); severe or untreated mental health illnesses (including eating disorders); active cancer or requiring treatment for cancer; other health conditions, (e.g. orthopaedic or neuromuscular limitations) or hospital admissions within the last 6 months that would make it difficult or unsafe to participate in the exercise sessions at home safely. prior mastectomy (breast removal);
• wrist circumference >22cm and upper arm circumference >64 cm because of the BP device size;
• participation in any other behaviour change program or clinical trial that may interfere with the outcomes of this study, e.g. weight loss, physical activity or drug;
• unable to speak English (a translator is not available) or give written informed consent;
• allergy to the silicone material from the BP device.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative data will be analysed using thematic analysis to determine key themes identified by participants using Nvivo software.

Descriptive analyses (mean, SD, percentage) will be used for assessing satisfaction, user experience, adherence and attrition outcomes. Satisfaction and user experience will be assessed online using 5-point rating scale ranging from strongly disagree to strongly disagree. Wrist-based blood pressure monitor accuracy will be compared to the values collected by Bluetooth cuff. Blood pressure data will be assessed for the missing data rate and days the bracelet is not worn

Hierarchical/multilevel models with an intention to treat approach will assess differences in the secondary outcomes from baseline and at 3 months between intervention and control groups. Interaction terms will detect potential differences in intervention effects between participants in residential environments that are less vs. more supportive of physical activity.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310406 0
University
Name [1] 310406 0
UNSW Cardiac, Vascular & Metabolic Medicine
Country [1] 310406 0
Australia
Primary sponsor type
Individual
Name
A/Prof Xiaoqi Feng
Address
Room 322, Level 3, Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW, Australia
Country
Australia
Secondary sponsor category [1] 311560 0
University
Name [1] 311560 0
Clinical Trial Governance Office, University of New South Wales
Address [1] 311560 0
Research Ethics and Compliance Support (RECS) , Level 3, Rupert Myers Building (South Wing), Kensington 2052, NSW, Australia
Country [1] 311560 0
Australia
Secondary sponsor category [2] 311568 0
Individual
Name [2] 311568 0
Prof Alta Schutte
Address [2] 311568 0
Room 309, Level 3, Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW, Australia
Country [2] 311568 0
Australia
Other collaborator category [1] 282097 0
Individual
Name [1] 282097 0
Prof Bruce Neal
Address [1] 282097 0
The George Institute for Global Health, Level 5, 1 King Street, Newtown, 2042, NSW, Australia
Country [1] 282097 0
Australia
Other collaborator category [2] 282098 0
Individual
Name [2] 282098 0
A/Prof Belinda Parmenter
Address [2] 282098 0
Room 234, Level 2 East, Wallace Wurth Building, University of New South Wales, Randwick 2031, NSW, Australia
Country [2] 282098 0
Australia
Other collaborator category [3] 282100 0
Individual
Name [3] 282100 0
Dr Alexandra Jones
Address [3] 282100 0
The George Institute for Global Health, Level 5, 1 King Street, Newtown NSW 2042 Australia
Country [3] 282100 0
Australia
Other collaborator category [4] 282101 0
Individual
Name [4] 282101 0
Ria Arnold
Address [4] 282101 0
Level 2 East, Wallace Wurth Building, Department of Exercise Physiology, UNSW Sydney, Randwick 2031, NSW, Australia
Country [4] 282101 0
Australia
Other collaborator category [5] 282102 0
Individual
Name [5] 282102 0
Dr Jennifer Yu
Address [5] 282102 0
Level 3, Campus Centre, Prince of Wales Hospital, Barker St, RANDWICK NSW 2031, Australia
Country [5] 282102 0
Australia
Other collaborator category [6] 282103 0
Individual
Name [6] 282103 0
Dr Sonali Gnanenthiran
Address [6] 282103 0
The George Institute for Global Health, Level 5, 1 King Street, Newtown NSW 2042 Australia
Country [6] 282103 0
Australia
Other collaborator category [7] 282104 0
Individual
Name [7] 282104 0
Kelly Mcleod
Address [7] 282104 0
Level 2 East, Wallace Wurth Building, Department of Exercise Physiology, UNSW Sydney, Randwick 2031, NSW, Australia
Country [7] 282104 0
Australia
Other collaborator category [8] 282105 0
Individual
Name [8] 282105 0
Tamara Raso
Address [8] 282105 0
Level 3, Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW, Australia
Country [8] 282105 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310054 0
The University of New South Wales Research Ethics Committee B
Ethics committee address [1] 310054 0
Ethics committee country [1] 310054 0
Australia
Date submitted for ethics approval [1] 310054 0
08/11/2021
Approval date [1] 310054 0
09/12/2021
Ethics approval number [1] 310054 0
HC210938

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

Contacts
Principal investigator
Name 116326 0
A/Prof Xiaoqi Feng
Address 116326 0
Room 322, Level 3, Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW
Country 116326 0
Australia
Phone 116326 0
+61293851135
Fax 116326 0
Email 116326 0
[email protected]
Contact person for public queries
Name 116327 0
Xiaoqi Feng
Address 116327 0
Room 322, Level 3, Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW
Country 116327 0
Australia
Phone 116327 0
+61293851135
Fax 116327 0
Email 116327 0
[email protected]
Contact person for scientific queries
Name 116328 0
Xiaoqi Feng
Address 116328 0
Room 322, Level 3, Samuels Building, Samuel Terry Ave, University of New South Wales, Kensington 2033, NSW
Country 116328 0
Australia
Phone 116328 0
+61293851135
Fax 116328 0
Email 116328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.