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Trial registered on ANZCTR


Registration number
ACTRN12616000566437
Ethics application status
Approved
Date submitted
28/04/2016
Date registered
2/05/2016
Date last updated
6/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiotherapy & Physical Activity Promotion in healthy adults: Is measurement alone enough?: a pilot study.
Scientific title
Physiotherapy & Physical Activity Promotion in healthy adults: Is measurement alone enough?: a pilot study.
Secondary ID [1] 289099 0
None
Universal Trial Number (UTN)
U1111-1182-4177
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical activity 298572 0
Condition category
Condition code
Cardiovascular 298643 298643 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 298652 298652 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapists are well placed in the primary care setting to promote and assess physical activity of healthy adults but the use of a ‘measurement as intervention’ approach for physical activity promotion has not been investigated. It is noteworthy, that physical activity intervention studies have reported improvements in physical activity among control group participants who were measured but did not receive the intervention being trialed at the time. This indicates that physical activity ‘measurement’, as a potential physical activity promoting intervention, is worthy of investigation.

Following recruitment of eligible participants, they will be randomised to one of two groups: physical activity measurement 1 (PAM1; baseline & 18-weeks) or physical activity measurement 2 (PAM2; baseline, 6, 12 & 18-weeks). The physiotherapist assessor at baseline and 18-weeks will be unaware of the participant’s group allocation. To identify a potential measurement effect, the groups will receive the measurement intervention on a different number of occasions depending on group allocation. PAM1 will receive the measurement intervention on 2 occasions (control) and PAM2 will receive the measurement intervention on 4 occasions, over an 18-week period. A different assessor (final year physiotherapy student) will be used for the physical activity assessments at 6 and 12-weeks.

Intervention
Physical activity measurement 1 (PAM1)
Outcome measures for participants randomised to PAM1 will be completed by a physiotherapist at the University of Canberra, giving participants an indication of their fitness and health status at baseline and 18-weeks. At baseline, participants will receive two brochures ‘An active way to better health. National Physical Activity Guidelines for Adults’ and ‘Dietary Guidelines for Australian Adults’ from the Department of Health and Ageing. The physical activity guidelines will be briefly discussed but they will not receive any other advice or support for increasing exercise or physical activity levels.

Physical activity measurement 2 (PAM2)
Outcome measures for participants randomised to PAM2 will be completed by a final year physiotherapy student at the University of Canberra, giving participants an indication of their fitness and health status at baseline, 6, 12 and 18-weeks. At baseline, participants will receive two brochures ‘An active way to better health. National Physical Activity Guidelines for Adults’ and ‘Dietary Guidelines for Australian Adults’ from the Department of Health and Ageing. The physical activity guidelines will be briefly discussed at each data collection point but they will not receive any other advice or support for increasing exercise or physical activity levels.
Intervention code [1] 294603 0
Lifestyle
Intervention code [2] 294604 0
Prevention
Comparator / control treatment
Physical activity measurement 1 (PAM1) as detailed above, will be the control group.
Control group
Active

Outcomes
Primary outcome [1] 298137 0
Moderate-to-vigorous physical activity (MVPA, minutes) measured by accelerometry (ActiGraph GT3X) and the Active Australia Survey (AAS).

Accelerometry will be used to validate the data collected from the AAS. These two continuous measures will be collected at baseline and 18-weeks. The AAS has been designed to measure participation in leisure time physical activity and to assess the participant’s knowledge of current public health messages about the health benefits of physical activity. It offers a short and reliable set of questions and applies to 1 week preceding the interview, including walking for transport. The AAS has been reported as reliable and of acceptable validity.

Covering the same time period as the AAS, participants will wear an Actigraph GT3X accelerometer for 7-consecutive days over their right hip (held in place with an elastic waist band) while awake. Accelerometers allow an objective measurement of quantity and intensity of movement and have been found to be reliable and valid. The raw data collected by the accelerometer will be used to obtain the time spent in different physical activity intensities. We will use the Freedson Combination energy expenditure algorithm to determine the intensity cut-points. This outcome variable will be used to investigate whether participants have reached the Australian physical activity guidelines (150 minutes MVPA and 5 sessions per week).
Timepoint [1] 298137 0
Baseline and 18-weeks.

Please note, accelerometry and the AAS will also be collected for PAM2 at 6 and 12-weeks.
Secondary outcome [1] 323252 0
Functional aerobic capacity (short self-paced step test (STEP protocol)).

The step test is an indirect measure of aerobic capacity, requiring a set of 2 x 20cm steps.Participants step up and down a standardized set of 2 steps, 20cm each 20 times at a self selected pace. Time to complete the test and post-test heart rate are recorded.
Timepoint [1] 323252 0
Baseline and 18-weeks.

Please note, the step test will also be conducted for PAM2 at 6 and 12-weeks.
Secondary outcome [2] 323253 0
Quality of life (AQoL-6D) - short self - administered questionnaire.

The Assessment of Quality of Life (AQoL) instruments are health-related multi-attribute utility quality of life instruments. The AQoL-6D takes 2-3 minutes for the participant to complete and covers the following dimensions - Independent Living, Mental Health, Coping, Relationships, Pain, Senses.
Timepoint [2] 323253 0
Baseline and 18-weeks.

Please note, the AQoL-6D will also be completed for PAM2 at 6 and 12-weeks.
Secondary outcome [3] 323254 0
Waist circumference (cm) - measurement of waist circumference with a tape measure
Timepoint [3] 323254 0
Baseline and 18-weeks.

Please note, waist circumference will be collected for PAM2 at 6 and 12-weeks.
Secondary outcome [4] 323255 0
Waist:hip ratio (WHR) - measurement of waist and hip circumference with a tape measure
Timepoint [4] 323255 0
Baseline and 18-weeks.

Please note, WHR will be collected for PAM2 at 6 and 12-weeks.
Secondary outcome [5] 323256 0
Blood pressure (mmHg) - measured via a sphygmomanometer
Timepoint [5] 323256 0
Baseline and 18-weeks.

Please note, blood pressure will be collected for PAM2 at 6 and 12-weeks.
Secondary outcome [6] 323257 0
Body mass index (BMI, kg/m2) - height and weight measures using a stadiometer and weight scales.
Timepoint [6] 323257 0
Baseline and 18-weeks.

Please note, BMI will be collected for PAM2 at 6 and 12-weeks.

Eligibility
Key inclusion criteria
Inclusion criteria
1. Between 18 and 64 years old (which is the age range for the physical activity (PA) guidelines for adults).
2. Participants must be insuffiently active (<150 mins moderate - vigorous PA (MVPA) per week)
3. They will have no serious medical conditions that could limit participation in moderate physical activity, such as unstable angina, uncontrolled hypertension, diagnosed or hospitalized with chest pain, heart attack or heart surgery in the past 6 months and no severe functional impairments due to multiple medical or psychiatric diseases.
4. They will not be planning to move from the ACT within 18-weeks.
5. Only one person per household will be eligible.
6. Participants will have adequate English skills and have appropriate cognitive skills to provide informed consent and increase physical activity levels, if desired.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical clearance screening will be undertaken using the Sports Medicine Australia (SMA) Pre-Exercise Screening System. If the participant answers ‘yes’ to any of the SMA screening questions, they will be asked to attend their local medical officer to receive medical clearance before they can be included in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed, with eligible participants receiving a sealed opaque envelope following their baseline assessment. The physiotherapy assessor at baseline and 18 weeks will be blinded to group allocation. To maintain blinding, a different physiotherapy ‘intervention assessor’ will be used for the remainder of the assessments. Participants will be encouraged not to inform the physiotherapy assessor at 18-weeks which group they were allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized (1:1 ratio) via computer-generated numbers to one of two groups: PA measurement 1 (PAM1; baseline & week 18) or PA measurement 2 (PAM2; baseline, week 6, 12 & 18).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will examine the effect of 6-weekly measurement of physical activity on physical activity undertaken 18-weeks after baseline (adjusting for any between group differences at baseline). The key purpose of this preliminary study is to understand the likely effect of this ‘measurement as intervention’ approach to inform sample size calculations for a future large-scale trial and therefore, there is no data available to inform power estimates for this study. Data will be analysed according to the intent-to-treat principle based on group assignment. Significance level will be set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2016
Actual
20/07/2016
Date of last participant enrolment
Anticipated
19/07/2016
Actual
21/07/2016
Date of last data collection
Anticipated
Actual
24/11/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 13187 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 293473 0
University
Name [1] 293473 0
University of Canberra
Country [1] 293473 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Freene
Address
Physiotherapy
Faculty of Health
University of Canberra
University Dr
Bruce
ACT 2617
Country
Australia
Secondary sponsor category [1] 292297 0
Individual
Name [1] 292297 0
Prof Rachel Davey
Address [1] 292297 0
Centre for Research & Action in Public Health
University of Canberra
University Dr
Bruce
ACT 2617
Country [1] 292297 0
Australia
Secondary sponsor category [2] 292298 0
Individual
Name [2] 292298 0
Assoc Prof Steven McPhail
Address [2] 292298 0
Public Health and Social Work
Faculty of Health
Queensland University of Technology
2 George St
Brisbane
QLD 4000
Country [2] 292298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294915 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 294915 0
Ethics committee country [1] 294915 0
Australia
Date submitted for ethics approval [1] 294915 0
08/02/2016
Approval date [1] 294915 0
09/03/2016
Ethics approval number [1] 294915 0
Project number 16-30

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

Contacts
Principal investigator
Name 65466 0
Dr Nicole Freene
Address 65466 0
Physiotherapy
Faculty of Health
University of Canberra
University Dr
Bruce
ACT 2617
Country 65466 0
Australia
Phone 65466 0
+61 2 6201 5550
Fax 65466 0
Email 65466 0
nicole.freene@canberra.edu.au
Contact person for public queries
Name 65467 0
Nicole Freene
Address 65467 0
Physiotherapy
Faculty of Health
University of Canberra
University Dr
Bruce
ACT 2617
Country 65467 0
Australia
Phone 65467 0
+61 2 6201 5550
Fax 65467 0
Email 65467 0
nicole.freene@canberra.edu.au
Contact person for scientific queries
Name 65468 0
Nicole Freene
Address 65468 0
Physiotherapy
Faculty of Health
University of Canberra
University Dr
Bruce
ACT 2617
Country 65468 0
Australia
Phone 65468 0
+61 2 6201 5550
Fax 65468 0
Email 65468 0
nicole.freene@canberra.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseFrequency of a very brief intervention by physiotherapists to increase physical activity levels in adults: A pilot randomised controlled trial.2019https://dx.doi.org/10.1186/s13102-019-0118-8
N.B. These documents automatically identified may not have been verified by the study sponsor.