Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001512213
Ethics application status
Approved
Date submitted
3/09/2018
Date registered
10/09/2018
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do older adults (peers/buddies) increase participation of older adults in strength and balance training
Scientific title
Do peers increase participation of older adults in strength and balance training
Secondary ID [1] 295974 0
Healthway Project Number 31966
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participation in strength and balance training 309485 0
Condition category
Condition code
Public Health 308319 308319 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strength training (ST): The ST program for both groups will run for 12-weeks and
participants will be assisted and encouraged to complete their ST program twice weekly. This
prescription accords with the guidelines for prescribing strength training program for older adults (American College of Sports Medicine. ACSM's guidelines for exercise testing and prescription. 9th ed. Baltimore, MD: Wolters Kluwer; Lippincott, Williams & Wilkins; 2014). A physiotherapist experienced in working with older people will individually prescribe and tailor the program for each participant in their home. The physiotherapist will visit each exercise participant every 4 weeks (3 sessions plus post-testing total). During these visits they will evaluate and assess each participant’s exercises and will give advice and add additional exercises / modify exercises according to each participant’s assessments. Participants will be provided with the program (hard copy) and a set of dumbbells, ankle weights and therabands of varying weights and strengths.
Each program will be individualized to each participant, in general they will be asked to complete 3 sets of 10-15 reps depending on their strength and balance levels at baseline assessment (ie tests used include TUG, 6MWT, STS-5, FR, tandem walk, hand grip strength) . Sessions will be for approx 45 minutes including warm up and cool down. Some of the exercises will include, squats, lunges, bicept curls, push ups against the wall etc
Peer Support: In addition to the ST the intervention group will receive peer support. This consists of peers providing encouragement and feedback from their experience in participating in ST and building relationships with the exercise participants to encourage them to continue with ST during and after the 12-week intervention. An initial meeting for peers and intervention group participants will be held face-to-face within the week of the initial assessment, and after the link is formally established, weekly contact (via phone call, minimum 5 minutes) commences and is scaled up according to each peer / participant pair, with support from the Peer Group coordinator (Research Assistant who is an older person). Peers complete an assessment sheet after each call which includes time on the phone or type of communication (if face to face is chosen), what was discussed, any issues, how they liked being a peer that day (likert scale). ST training participants complete a diary each time they participate in a workout which includes what exercises they did, what weight, how many sets and reps, how they enjoyed it that day (likert scale).

Intervention code [1] 312300 0
Lifestyle
Intervention code [2] 312301 0
Behaviour
Comparator / control treatment
The intervention group will receive the 12-week ST program from the same physiotherapists, which will be delivered in the same way, but they will not have any contact with a peer.
Control group
Active

Outcomes
Primary outcome [1] 307296 0
Feasibility of intervention:
i) numbers (proportion) of participants that choose to
progress to a ST program after the intervention is completed (phone call 4 weeks after intervention completed);
Timepoint [1] 307296 0
four weeks after the completion of the 12-week intervention
Primary outcome [2] 307297 0
Feasibility of intervention:
ii) Adherence to ST program during the intervention (ST participant diaries, notes from physiotherapist);
Timepoint [2] 307297 0
at the completion of the 12-week intervention
Primary outcome [3] 307322 0
Feasibility of intervention:
iii) details of recruitment and retention figures for both peers and exercisers (intervention and control) (CI and RA make note after each recruitment opportunity)
Timepoint [3] 307322 0
at the completion of the 12-week intervention
Secondary outcome [1] 351475 0
Timed-up-and-go test - measured using a stop watch
Timepoint [1] 351475 0
end of 12 week intervention
Secondary outcome [2] 351476 0
6-minute walk test - measured using a stop watch
Timepoint [2] 351476 0
end of 12 week intervention
Secondary outcome [3] 351477 0
chair sit to stand (5 times) measured using a stop watch
Timepoint [3] 351477 0
end of 12 week intervention
Secondary outcome [4] 351478 0
Functional Reach measured using a ruler
Timepoint [4] 351478 0
end of 12 week intervention
Secondary outcome [5] 351479 0
Timed Tandem Walk measured using a stop watch
Timepoint [5] 351479 0
end of 12 week intervention
Secondary outcome [6] 351480 0
Handgrip strength test measured using a dynanometer
Timepoint [6] 351480 0
end of 12 week intervention
Secondary outcome [7] 351481 0
health related quality of life (measured using EQ5D-5L)
Timepoint [7] 351481 0
end of 12 week intervention
Secondary outcome [8] 351482 0
self-efficacy for exercise measured using self efficacy for exercise survey
Timepoint [8] 351482 0
end of 12 week intervention
Secondary outcome [9] 351483 0
Participant (ST and peers) experiences in participating in project via focus groups for peers mid way through and interviews at the end
Timepoint [9] 351483 0
peers: during and at the end of 12 week intervention
ST participants at the end of the 12 week intervention

Eligibility
Key inclusion criteria
Study participants will include older adults who:
1. are participating in ST currently (>2months); they will be peer participants (n = 13)
2. are not currently participating in ST; they will be exercise participants (n = 50)
Inclusion criteria: aged 60+ years, no diagnosis of dementia, able to speak and understand English and have no medical conditions preventing them from participating in a ST program.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dementia, inability to understand English, has a medical condition preventing them from participating in a ST program.

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)
The physiotherapists will be gaining the exercise participant consent and delivering the ST programs. They will not know which exercise participants have a peer (intervention) and which do not. When an exercise participant has given consent and had their baseline assessment conducted the physiotherapist emails the lead CI who looks at the randomisation number chart for the ID number and alerts the Research Assistant (RA) to start the peer intervention with those exercise participants randomly allocated to the peer intervention. The lead CI conducts the peer training but has no contact with any of the exercise participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was undertaken by a statistician not involved in the project. Randomization was conducted using a randomization table created in Stata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcome measures data will be analysed using SPSS version 24. Where data are found to not be normally distributed, non-parametric tests will be utilised. The measurement outcome data will be compared using intention-to-treat analyses. Statistical significance will be considered at p=0.05.
Recruitment, withdrawal rates and data collection tool completion (exercise diaries and peer interactions) will be analysed as well as proportion of each group continuing on with ST at the completion of the intervention.
Interview data will be transcribed and summaries prepared to provide detail of the peer
experience and interactions with the exercise participants during the research study. Summary content will be analysed thematically and quotes identified that will serve as good illustrations of the themes identified. Initially two independent coders (CI-A and CI-B) will familiarise themselves with the data (reading, re-reading the transcriptions), they will both generate initial codes independently for all data (assisted with NVivo (NVivo qualitative data analysis Software; QSR International Pty Ltd) and then search for themes within the codes. Coders will then come together to review the themes and discuss
them until they form consensus. It is expected a thematic map of the results will be created.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2018
Date of last participant enrolment
Anticipated
31/10/2018
Actual
2/11/2018
Date of last data collection
Anticipated
28/02/2019
Actual
8/02/2019
Sample size
Target
50
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 300570 0
Charities/Societies/Foundations
Name [1] 300570 0
Healthway
Country [1] 300570 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
32 Mouat St,
Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 300069 0
None
Name [1] 300069 0
Address [1] 300069 0
Country [1] 300069 0
Other collaborator category [1] 280332 0
University
Name [1] 280332 0
Curtin University
Address [1] 280332 0
Kent Street
Bentley WA 6102
Country [1] 280332 0
Australia
Other collaborator category [2] 280333 0
Charities/Societies/Foundations
Name [2] 280333 0
Council on the Ageing WA
Address [2] 280333 0
61, The Perron Centre, Kitchener Ave,
Perth WA 6100
Country [2] 280333 0
Australia
Other collaborator category [3] 280334 0
Commercial sector/Industry
Name [3] 280334 0
Amana Living
Address [3] 280334 0
Level 1/1-9 Tanunda Dr,
Rivervale WA 6103
Country [3] 280334 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301360 0
the University of Notre Dame (Australia) Human Research Ethics Commitee
Ethics committee address [1] 301360 0
Ethics committee country [1] 301360 0
Australia
Date submitted for ethics approval [1] 301360 0
15/01/2018
Approval date [1] 301360 0
15/02/2018
Ethics approval number [1] 301360 0
018012F

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

Contacts
Principal investigator
Name 86742 0
Dr Elissa Burton
Address 86742 0
Institute for Health Research
The University of Notre Dame (Australia)
19 Mouat Street
Fremantle WA 6959
Country 86742 0
Australia
Phone 86742 0
+61 8 9266 4926
Fax 86742 0
NA
Email 86742 0
[email protected]
Contact person for public queries
Name 86743 0
Elissa Burton
Address 86743 0
Institute for Health Research
The University of Notre Dame (Australia)
19 Mouat Street
Fremantle WA 6959
Country 86743 0
Australia
Phone 86743 0
+61 8 9266 4926
Fax 86743 0
NA
Email 86743 0
[email protected]
Contact person for scientific queries
Name 86744 0
Elissa Burton
Address 86744 0
Institute for Health Research
The University of Notre Dame (Australia)
19 Mouat Street
Fremantle WA 6959
Country 86744 0
Australia
Phone 86744 0
+61 8 9266 4926
Fax 86744 0
NA
Email 86744 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
Data analysis is still be undertaken and individual trial data will not be available as it is a small sample and participants consented to not being identified


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.