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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sedentary behavoiur

Insufficient physical activity

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

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]

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]

Accumulation of vigorous-intensity physical activity assessed by actigraph.

Timepoint [1]

Accumulation of vigorous-intensity physical activity is to be assessed at week 0, week 6, and week 12 of the intervention.

Secondary outcome [2]

Self-reported general health and wellbeing by SF-36

Timepoint [2]

SF-36 is to be administered at Week 0 and week 12 of the intervention

Secondary outcome [3]

Resting blood pressure and heart rate by automated blood pressure machine

Timepoint [3]

Resting blood pressure and heart rate will be measured at Week 0 and 12 of the intervention

Secondary outcome [4]

Physical activity duration and intensity assessed by actigraph

Timepoint [4]

Physical activity duration and intensity will be assessed at Week 0, week 6 and week 12 of the intervention

Secondary outcome [5]

Functional fitness by 6-minute-walking test

Timepoint [5]

6-minute-walking-test to be assessed at week 0, week 6 and week 12 of the intervention

Secondary outcome [6]

Physical habit formation by standardised habit formation survey

Timepoint [6]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent St, Bentley WA 6102

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent St, Bentley WA 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Kent St, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/04/2023

Approval date [1]

09/05/2023

Ethics approval number [1]

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

A/Prof Joanne McVeigh

Address

Curtin University, Kent St, Bentley WA 6102

Country

Australia

Phone

+61 8 9266 7247

Fax

[email protected]

Contact person for public queries

Name

Bingyan Pang

Address

Curtin University, Kent St, Bentley WA 6102

Country

Australia

Phone

+61 449 789 370

Fax

[email protected]

Contact person for scientific queries

Name

Bingyan Pang

Address

Curtin University, Kent St, Bentley WA 6102

Country

Australia

Phone

+61 449 789 370

Fax

[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?

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, [email protected]) and contact of the project (Bingyan Pang, [email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19020	Informed consent form					385822-(Uploaded-01-05-2023-13-36-53)-Study-related document.docx
19023	Ethical approval			[email protected]	Ethics approval letter will be uploaded upon gaini... [More Details]

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.

Trial Review

Documents added manually

Documents added automatically