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Trial registered on ANZCTR


Registration number
ACTRN12623000493640
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
12/05/2023
Date last updated
25/04/2024
Date data sharing statement initially provided
12/05/2023
Date results information initially provided
25/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial of a 12-week Vigorous Intermittent Lifestyle Physical Activity (VILPA) program in inactive adults transitioning to retirement
Scientific title
A feasibility pilot randomised controlled trial of an intervention to promote Vigorous Intermittent Lifestyle Physical Activity (VILPA) in insufficiently physically active adults transitioning to retirement
Secondary ID [1] 309560 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behavoiur 329850 0
Insufficient physical activity 329851 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326760 326760 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are conducting a randomised controlled feasibility trial to test an intervention to promote vigorous intermittent lifestyle physical activity (VILPA) in adults transitioning to retirement. The intervention was co-developed with adults transitioning to retirement and health professionals. The intervention will be delivered by a PhD student at Curtin University. The PhD student is a registered allied health professional in Australia. The intervention involves a 12-week personalised VILPA program. Participants in the intervention group will receive a personalised physical copy of VILPA booklet. The VILPA booklet is designed specifically for this study. The VILPA booklet is personalised according to each participant's physical capability, baseline virogous intensity heart rate, and daily activities. The types of VILPA will depend on the participant's physical cability and daily activities. Some examples of VILPA are climbing a few flights of stairs, brisk walk from home to bus stop, walking uphill, carrying a small load of shopping for more than 50 meters, playing with or carrying a small child, vacuuming, and mowing the lawn.

The intensity of the VILPA intervention is assessed by Borg RPE. Participants will look at their own weekly schedule, and identify potential daily living activities that could be VILPA. The duration of each bout of VILPA will depend on each participant's baseline capability and daily schedule, however, each bout duration of VILPA will be less than 2 to 3minutes. The frequency of VILPA will depend on each participant's baseline capability and daily schedule. The aim of the intervention is to accumulate a total of 75 minutes of VILPA each week, or 11 minutes of VILPA each day, for the duration of the 12-week intervention. Participants have the option to increase in frequency and duration of VILPA depending on their own capability, and their goals set in Week 1 of the intervention.

Participants in the waitlist group will receive a print copy of the current World Health Organization recommendation in physical activity. Participants in the waitlist group will receive the intervention after the participants in the intervention group have completed the trial.

The mode of administration of the VILPA intervention will be one-on-one at the baseline measurement, mid-way follow-up, and end-of-intervention follow-up. Participants in the intervention group will be assigned to a random group of 5 for their WhatsApp group. Participants will use the VILPA booklet and do the intervention on their own, according to their daily living activities.

Week 0
All eligible participants will attend Curtin University (Bentley, Western Australia) for all pre-intervention measurements. Pre-intervention measurements include a short survey (SF-36) on their general health status, a six-minute walking test for their functional fitness, and resting heart rate and blood pressure. Each participant will wear an Actigraph monitor (accelerometer) for seven days to track their pre-intervention physical activity (PA) intensity and duration.

Participants in the intervention group will wear a FitBit Inspire 3 during their 6-minute walking test to record their own vigorous PA heart rate on their printed VILPA intervention booklet.

Week 1 to 12
Participants in the wait-list group will receive the current World Health Organization physical activity recommendation via a printed brochure – accumulate 75 to 150 minutes of vigorous-intensity physical activity or 150 to 300 minutes of moderate-intensity physical activity a week.

Participants in the intervention group will receive the VILPA intervention. They will receive a VILPA intervention booklet. This booklet includes education on VILPA and 12 weekly VILPA checklists. Participants will use their weekly VILPA checklist to record the types and minutes of VILPA performed each day. Participants in the intervention group will be invited to join a WhatsApp group. A WhatsApp group was noted as the preferred form of communication in the intervention development phase of the project. The purpose of the WhatsApp group will be for the PhD student to send VILPA reminders, VILPA tracking and monitoring reminders, VILPA information and also allow participants to share ideas to keep motivated to do VILPA.
Week 1 to 2: participants in the intervention group will use a FitBit Inspire 3 to check their total minutes of heart rate in their vigorous zone each day. Participants will receive a daily mobile notification to complete their checklist relating to the types of VILPA they performed, as well as the total minutes of vigorous physical activity shown on their Fitbit Inspire 3. They will record the types of VILPA performed, and total minutes of vigorous physical activity on their VILPA intervention booklet.
Week 3 to 5: participants in the intervention group will reflect on their total accumulation of VILPA per week in Week 1 and 2, self-identify solutions to keep motivated to accumulate sufficient VILPA in the rest of the intervention duration. Participants may use the WhatsApp group to post their achievements of VILPA and/or share ideas to keep themselves motivated. Participants will continue with the VILPA intervention without a Fitbit Inspire 3. They will receive a mobile notification every 3 days to complete their checklists relating to the types of VILPA they performed and minutes of each activity.
Week 6 to 7: participants in both waitlist and the intervention group will attend Curtin University for all mid-way intervention measurements. These measurements include a short survey (SF-36) on their general health status, a six-minute walking test for their functional fitness, and resting heart rate and blood pressure. In addition, participants in the intervention group will wear a FitBit Inspire 3 during their 6-minute walking test to record their own vigorous PA heart rate in their VILPA intervention booklet.
Participants in both waitlist and the intervention groups will also wear an Actigraph monitor for seven days to track their mid-way intervention PA intensity and duration.
Participants in the intervention group will continue with the VILPA intervention a Fitbit Inspire 3 for two weeks, their vigorous heart rate zone will be modified according to their mid-way six-minute walking test finding. They will receive a mobile notification every 3 days to complete their checklists relating to the types of VILPA they performed, as well as the total minutes of vigorous physical activity shown on their Fitbit Inspire 3. All recordings are to be done in their VILPA intervention booklet.
Week 8/9 to 11: participants in the intervention group will continue without the VILPA intervention a Fitbit Inspire 3. They will receive a mobile notification once a week to complete their chechklist relating to the types of VILPA they performed.
Week 12: participants in both waitlist and the intervention group will attend Curtin University for all end-of-intervention measurements. These measurements include a short survey (SF-36) on their general health status, a six-minute walking test for their functional fitness, and resting heart rate and blood pressure. Participants in the intervention group will wear a FitBit Inspire 3 during their 6-minute walking test to record their own vigorous PA heart rate on their VILPA intervention booklet. Participants in both waitlist and intervention groups will also wear an Actigraph monitor for seven days to track their final PA intensity and duration.

Week 13
VILPA intervention will be offered to the wait-list participants.

One-month post-intervention
Participants in the intervention group will complete a 5-min online or telephone survey for post-intervention evaluation and physical activity maintenance. See additional materials for survey questions.

Three-month post-intervention
Participants in the intervention group will complete a 5-min online or telephone survey for post-intervention evaluation and physical activity maintenance. See additional materials for survey questions.
Intervention code [1] 325984 0
Lifestyle
Comparator / control treatment
We will have a waitlist group in this feasibility randomised controlled pilot. Participants in the waitlist group will receive a print copy of the current World Health Organization recommendation in physical activity.

The VILPA intervention will be offered to the wait-list participants in week 13.
Control group
Active

Outcomes
Primary outcome [1] 334617 0
The primary outcome is a composite of feasibility and acceptability of the VILPA intervention.
Feasibility is assessed by recruitment from study records, completion of the intervention from participant VILPA checklists in their booklets, maintenance of VILPA participation from immediate and follow-up surveys, and resources required for the intervention from study records.
Acceptability is assessed by completion of the intervention from participant VILPA checklists in their booklets, and standardised study surveys from immediate follow-ups.
Timepoint [1] 334617 0
Recruitment rates are determined 6 months after the study starts.
Completion of intervention is determined at week 6, and week 12 of the intervention.
Maintenance of the intervention is determined at week 12 of the intervention, 1 month and 3 months post-intervention.
Resources for intervention is determined at week 12 of the intervention.
Acceptability survey completed at 12 weeks after the intervention commencement.
Secondary outcome [1] 421427 0
Accumulation of vigorous-intensity physical activity assessed by actigraph.
Timepoint [1] 421427 0
Accumulation of vigorous-intensity physical activity is to be assessed at week 0, week 6, and week 12 of the intervention.
Secondary outcome [2] 421644 0
Self-reported general health and wellbeing by SF-36
Timepoint [2] 421644 0
SF-36 is to be administered at Week 0 and week 12 of the intervention
Secondary outcome [3] 421645 0
Resting blood pressure and heart rate by automated blood pressure machine
Timepoint [3] 421645 0
Resting blood pressure and heart rate will be measured at Week 0 and 12 of the intervention
Secondary outcome [4] 421646 0
Physical activity duration and intensity assessed by actigraph
Timepoint [4] 421646 0
Physical activity duration and intensity will be assessed at Week 0, week 6 and week 12 of the intervention
Secondary outcome [5] 421647 0
Functional fitness by 6-minute-walking test
Timepoint [5] 421647 0
6-minute-walking-test to be assessed at week 0, week 6 and week 12 of the intervention
Secondary outcome [6] 421648 0
Physical habit formation by standardised habit formation survey
Timepoint [6] 421648 0
Physical activity habit formation survey to be administered at the end of week 12 of the intervention, 1 month and 3 months post-intervention

Eligibility
Key inclusion criteria
Eligible participants will be adults who are planning to retire in the next five years or recently retired in the past six months, who do not participate in sufficient physical activity, have no life-threatening physical or mental health conditions which prevent them from doing VILPA, speaks English and lives in Perth metropolitan area. Each prospective participant will answer a physical activity readiness questionnaire, individuals who answer yes to any of the questions will be encouraged to seek general practitioner advice prior to enrolling in the study.

Sufficient physical activity is defined as accumulation of 75 minutes of vigorous-intensity physical activity a week, or 150 minutes of moderate-intensity physical activity or week.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have fully retired for more than 6 months, or do not plan to retire in the next five years, who have life-threatening physical or mental health conditions which prevent them from doing VILPA, or who deemed unsafe by their general practitioner to engage in VILPA

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by computer-generated block size of five
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will recruit 80 participants, 40 in each arm. Data collected via ActiGraph will be exported using ActiGraph program (ActiLife), summarised in R Studio, and analysed in SPSS. Feasibility measures will be reported using descriptive data. Provided this pilot will recruit the proposed number of participants, quantitative data will be analysed using linear mixed modelling to assess changes in the outcomes in the control and intervention groups. Qualitative data on barriers to participation in VILPA will be imported and analysed in NVivo. Fitbit data will be collected and gathered via cloud-based platform and analysed in SPSS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2023
Actual
10/07/2023
Date of last participant enrolment
Anticipated
30/10/2023
Actual
15/09/2023
Date of last data collection
Anticipated
31/03/2024
Actual
31/03/2024
Sample size
Target
80
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313751 0
University
Name [1] 313751 0
Curtin University
Country [1] 313751 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 315575 0
None
Name [1] 315575 0
Address [1] 315575 0
Country [1] 315575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312922 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 312922 0
Kent St, Bentley WA 6102
Ethics committee country [1] 312922 0
Australia
Date submitted for ethics approval [1] 312922 0
15/04/2023
Approval date [1] 312922 0
09/05/2023
Ethics approval number [1] 312922 0
HRE2022-0304-07

Summary
Brief summary
To examine the feasibility and acceptability of a 12-week VILPA intervention to increase physical activity (PA) in insufficiently physically active adults who are transitioning to retirement. This study will be a pilot randomised controlled trial with two groups of participants using the adapted Consolidated Standards of Reporting Trials (CONSORT) statement. Eligible participants will be randomised to either a waitlist or intervention group. The intervention group will receive the intervention for 12 weeks. The waitlist group will receive current physical activity recommendation by the World Health Organization until the intervention group has completed their 12-week trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126346 0
A/Prof Joanne McVeigh
Address 126346 0
Curtin University, Kent St, Bentley WA 6102
Country 126346 0
Australia
Phone 126346 0
+61 8 9266 7247
Fax 126346 0
Email 126346 0
joanne.mcveigh@curtin.edu.au
Contact person for public queries
Name 126347 0
Miss Bingyan Pang
Address 126347 0
Curtin University, Kent St, Bentley WA 6102
Country 126347 0
Australia
Phone 126347 0
+61 449 789 370
Fax 126347 0
Email 126347 0
bingyan.pang@curtin.edu.au
Contact person for scientific queries
Name 126348 0
Miss Bingyan Pang
Address 126348 0
Curtin University, Kent St, Bentley WA 6102
Country 126348 0
Australia
Phone 126348 0
+61 449 789 370
Fax 126348 0
Email 126348 0
bingyan.pang@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participants' data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access is subjected to approvals by Principle Investigation (Joanne McVeigh, joanne.mcveigh@curtin.edu.au) and contact of the project (Bingyan Pang, bingyan.pang@curtin.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19020Informed consent form    385822-(Uploaded-01-05-2023-13-36-53)-Study-related document.docx
19023Ethical approval  bingyan.pang@curtin.edu.au Ethics approval letter will be uploaded upon gaini... [More Details]



Results publications and other study-related documents

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