Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001104549
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
20/10/2015
Date last updated
17/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of ongoing feedback on compliance with physical activity following an exercise intervention in chronic disease
Scientific title
Do older adults with chronic conditions, who receive 12 month telephone or activity tracker follow up, compared to usual care, have increased adherence to physical activity following an exercise intervention?
Secondary ID [1] 287276 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Health Conditions 295907 0
Frailty
295908 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296159 296159 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals who are referred to the Strength2strength (S2S) Program are offered the opportunity to take part in a 12-month follow up study once they have completed the initial 12-week S2S program.
Following completion of the 12-week S2S program, participants are allocated into one of three treatment groups - Usual care, telephone counselling or Activity tracker.

Usual care
Participants are asked to self-report their activity levels via a follow up questionnaire 3, 6 and 12 months post program completion. Participants are asked to report if their activity levels have increased, decreased or stayed the same and the reason for decrease if applicable. They are also asked to report on their sitting time and to rate their confidence and motivation to continue to participate in physical activity. Participants also attend the S2S clinic at 3, 6 and 12 months post program for assessment and functional testing.

Telephone counselling
Participants receive a total of fifteen (15) calls throughout the 12 month follow up period. For the first 3 months participants receive fortnightly calls. This is increased to monthly calls for the remaining 9 months. All telephone calls are conducted by an Accredited Exercise Physiologist (AEP) with training in motivational interviewing techniques. A protocol is followed by the AEP for each phone call to ensure consisted information is collected. The AEP is able to provide advice regarding exercise prescription and assist participants to overcome any barriers that may be preventing them from being physically active. Participants also attend the S2S clinic at 3, 6 and 12 months post program for assessment and functional testing.

Activity Tracker
Participants are asked to wear a Jawbone(TM) activity tracker for the 12-month follow up period. Each participant is provided with training on how to use the activity tracker and how to synchronise the device with the tablet provided.
Participants are asked to synchronise their step data at the end of each day. Failure to do so prompt an automatic text reminding the participant to synchronise and charge their activity tracker. Participants are provided with specific feedback regarding their activity levels. Additionally, participants receive real time feedback in the form of a vibrotactile alert from the device itself following a set period of inactivity. Individual goals for each participant are set by the AEP following the completion of the 12-week S2S program. Participants also attend the S2S clinic at 3, 6 and 12 months post program for assessment and functional testing.
Intervention code [1] 292618 0
Lifestyle
Comparator / control treatment
Telephone Counselling is active control
Activity Tracker is intervention
Usual Care - standard treatment
Control group
Active

Outcomes
Primary outcome [1] 295867 0
Physical activity levels

Measured via ActivPal monitor fitted to participants leg for 7-day period
Timepoint [1] 295867 0
At 3, 6 and 12 months after randomisation
Secondary outcome [1] 316756 0
Health services utilisation

Measured via a 'Health Service Diary' in which participants are asked to document any health services accessed.
Timepoint [1] 316756 0
one year following randomisation

Eligibility
Key inclusion criteria
Individuals who have completed the 12-week Strength2Strength Exercise Treatment Program
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who decline to participate in the 12-week S2S Program
Individuals with an unstable medical condition that prevents them from participating in regular physical activity
Individuals with a limited understanding of English which may prevent them from meeting the self-reporting requirements of 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)
At the time of initial assessment to take part in the S2S program, one of the study investigators outline the nature of the study and invite the participant to take part in the study. Participants are made aware that participation in the study is optional and their decision of whether or not to take part in the study will not affect their eligibility to take part in the 12-week S2S program.
Once a participant has been recruited, they complete the 12-week S2S program as per usual.
At the time of discharge, participants are randomised into one of the three intervention groups (Usual Care, Telephone Counselling or Activity Tracker). The randomisation is recorded in a sealed opaque envelope. Each envelope was opened sequentially at the completion of the S2S program to reveal the allocated intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is completed by a third party not directly involved in the delivery of the S2S program.
In the event that there are multiple participants from the same household, they are randomised to the same intervention to maintain the integrity of the intervention.
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
Power Calculation
A preliminary power calculation was performed based on an observed increase of approximately 450 MET.min of physical activity per week in a small group of participants following the completion of the 12-week S2S program with a SD of the change. Sample size was calculated based on a predicted maintenance of 100% of additional physical activity in the feedback groups and decrease of 50% of additional physical activity in the usual care group over the 12 month intervention (MD=225 MET.min/week) with SD of the change of 350 MET.min/week (roughly 1.5 times the mean change in line with S2S data). The sample size calculation indicated that to obtain a power of 80%, at least 38 participants were required per group. To allow for potential withdrawals 50 participants per group will be recruited.
All statistical analyses were performed using STATA statistical software (Stata 13; Statistical data analysis; Stata Corp; College Station; Texas, USA). Baseline and descriptive data between the groups was analysed with one way ANOVA. Binary categorical data was analysed for variability between the groups using logistic regression. Parametric longitudinal data was analysed using mixed effects linear regression with unstructured covariance, corrected for repeated measures. In the event that assumptions of linear regression (heteroskedascity, skewness, kurtosis or non-linearity) were violated, those analyses were repeated using repeated measures ordinal logistic regression. p-values were corrected where appropriate for multiple comparisons using the Holm test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/05/2015
Date of last participant enrolment
Anticipated
30/03/2016
Actual
14/06/2016
Date of last data collection
Anticipated
Actual
9/08/2017
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 10183 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 292220 0
Self funded/Unfunded
Name [1] 292220 0
Country [1] 292220 0
Primary sponsor type
University
Name
University of Tasmania
Address
Newnham Drive
Newnham, TAS 7248
Country
Australia
Secondary sponsor category [1] 290679 0
Other
Name [1] 290679 0
Primary Health Tasmania
Address [1] 290679 0
41 Frankland Street
Launceston TAS 7250
Country [1] 290679 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293354 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 293354 0
Ethics committee country [1] 293354 0
Australia
Date submitted for ethics approval [1] 293354 0
Approval date [1] 293354 0
01/05/2015
Ethics approval number [1] 293354 0
H0014713

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

Contacts
Principal investigator
Name 59530 0
Mrs Katie-Jane Brickwood
Address 59530 0
Exercise Physiology Clinic
University of Tasmania
Newnham Drive
Newnham TAS 7248
Country 59530 0
Australia
Phone 59530 0
+61408484874
Fax 59530 0
Email 59530 0
[email protected]
Contact person for public queries
Name 59531 0
Katie-Jane Brickwood
Address 59531 0
Exercise Physiology Clinic
University of Tasmania
Newnham Drive
Newnham TAS 7248
Country 59531 0
Australia
Phone 59531 0
+61408484874
Fax 59531 0
Email 59531 0
[email protected]
Contact person for scientific queries
Name 59532 0
Andrew Williams
Address 59532 0
University of Tasmania
Newnham Drive
Newnham TAS 7248
Country 59532 0
Australia
Phone 59532 0
+61363245487
Fax 59532 0
Email 59532 0
[email protected]

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
EmbaseThe effect of ongoing feedback on physical activity levels following an exercise intervention in older adults: A randomised controlled trial protocol.2016https://dx.doi.org/10.1186/s13102-016-0066-5
EmbaseEffects of Activity Tracker Use With Health Professional Support or Telephone Counseling on Maintenance of Physical Activity and Health Outcomes in Older Adults: Randomized Controlled Trial.2021https://dx.doi.org/10.2196/18686
N.B. These documents automatically identified may not have been verified by the study sponsor.