Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000454370
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
28/03/2017
Date last updated
2/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining the feasibility of encouraging adults aged 65 years and above to participate in resistance training using peers: A pilot study
Scientific title
Determining the feasibility of encouraging adults aged 65 years and above to participate in resistance training through peer (buddy) systems: A pilot study
Secondary ID [1] 291289 0
Nil known
Universal Trial Number (UTN)
U1111-1193-5649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lack of adherence to resistance training in older people 302250 0
Condition category
Condition code
Other 301844 301844 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise program will be developed to meet the American College of Sports Medicine (ACSM) and Centers for Disease Control and Prevention (CDC) guidelines given there are no specific Australian guidelines. Those participating in the gymnasium exercise program will be led by an employee qualified to prescribe resistance training (RT) programs for older people and attend the gymnasium program twice a week for 6 weeks. Exercises will be conducted on resistance training equipment eg let pull down, leg extension etc. Each gymnasium program will be individualised to each participant, however they will all train at the same time in a group and meet and speak with their peer during this time. These sessions take between 1-1.5 hours and participants are encouraged to attend twice a week.
Those participating at home will be provided with an individualised program prescribed by a physiotherapist (different person from the gymnasium program). They will undergo an assessment with the physiotherapist and then receive an individualised program tailored to their needs (type of exercises, weight used, etc will differ depending on the participants needs). They will receive hard copies of the exercises to undertake (given as a reminder) and a set of dumbbells, ankle weights and therabands of varying weights and strengths (this will be progressively increased over the 6 weeks). The physiotherapist will demonstrate/instruct each participant in the home program. Participants will be asked to complete the program twice a week for 6 weeks in their own time. The physiotherapist will return every 2 weeks to review the home participants and make adjustments as required (increase weight and/or introduce new exercises). Each session the participants complete by themselves is expected to take approximately 1 hour. The peers will contact them at times outside of their training.
The peer training will be developed with the assistance of a Council of the Ageing Western Australia (COTAWA) employee (partner on the project) and an experienced peer leader (consumer representative on project team) who has been training older people to be peer leaders for a number of years. Both have extensive experience in developing and delivering peer training to older people and both also hold a Degree in Education. The peer training will be held for half a day, and will include the role of the peer, benefits of resistance training to older people, benefits of having a peer in other types of interventions e.g. falls prevention, motivational aspects of being a peer, active listening etc. Peers will be asked to contact the exercise participant at least once a week but after this it is optional as it is a pilot we want to determine how much communication the peers and exercises had. The peers at the gymnasium will welcome the exercise participant, chat with them during the work out and if they need any assistance with equipment that does not require the exercise physiologists' help they are encouraged to assist. The peers assisting the home exercise participants main goal is to motivate the exerciser and show empathy where required also (i.e. if home exerciser is sore from doing strength training for the first time they can empathise as they have probably already experienced this). The peers with the home exercise participants are not encouraged to talk about the exercises too much due to safety and technique issues and using different types of equipment to those in the gym. Individual peers have been assigned to both the gym and exercise group to explore the differences in being a peer in both settings. Peers will be assigned anywhere between 1 and 4 exercise participants dependent on what they feel they can handle, this will be explored in the post-testing interviews. Expectations prior to and after the training will be sought and feedback from the peer leaders at the completion of the six weeks will be collected via interview.
Intervention code [1] 297311 0
Treatment: Other
Comparator / control treatment
No control group. This is a pilot study testing two types of interventions (at home, in the gymnasium - both using peers) that can then be trialled against a comparator/control in a future study.
Control group
Active

Outcomes
Primary outcome [1] 301266 0
Adherence to resistance training program assessed using a log of gym attendance or using an exercise diary (for participants in the home exercise group). Adherence will be assessed through use of the gymnasium attendance sheet and an exercise diary by the home participants.
Timepoint [1] 301266 0
Adherence (twice a week) for six weeks.
Secondary outcome [1] 332154 0
Explore the experience of peers in the intervention (i.e. gymnasium and home program) throughout the project via focus groups and interviews.
Timepoint [1] 332154 0
Focus groups: Held at completion of peer training (conducted prior to resistance training commencing) and meeting with peers at halfway point of data collection. Also after post-data collection of exercise participants is completed all peers will be interviewed about their experiences..
Secondary outcome [2] 332155 0
Composite outcome: determine the recruitment rate and identify potential recruitment issues to be avoided for a larger study. This outcome will be calculated by dividing the number of people we approached by the number that agreed to be involved). Recruitment issues will be documented by the research assistant recruiting participants and thematically coded.
Timepoint [2] 332155 0
At completion of the data analysis.
Secondary outcome [3] 332156 0
Determine the drop out (withdrawal) rate for this population. Calculated by dividing the number of participants to complete the intervention program by the number that provided consent.
Timepoint [3] 332156 0
At the completion of data analysis

Eligibility
Key inclusion criteria
Study participants will include older people (65 years and over) who:
1) are participating as a peer (or buddy);
2) are physically active but not currently participating in RT; or
3) are not physically active and have not undertaken RT previously.
Inclusion criteria will include: people aged 65 years and over, no diagnosis of dementia, able to speak and understand English and have no medical conditions preventing them from participating in an exercise program that includes RT program.
Peers will also need to be currently participating in a RT program.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants
Diagnosis of dementia
Health condition preventing them from taking part in a resistance training program
Peers
As above and not currently or never participated in a resistance training program

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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)
Not required. Those attending the gymnasium had been physically active (e.g. walking regularly, other types of exercise) but not participating in resistance training, those receiving the home based program were not active on a regular basis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This will be a two group (1) resistance training (RT) in a gymnasium and 2) resistance training in the home), pre- and post-test feasibility study using a peer (buddy) system for motivation/encouragement.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment and withdrawal rates and data collection tool completion will be analysed. Data from the peers and participants will be used to assess the feasibility of the motivational training for the peers and RT program and how the peers and participants interacted. The 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, with paired t-tests and Wilcoxon signed rank tests used to compare per- and post-test results. Statistical significance will be considered at p = 0.05. Interviews will be thematically analysed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/02/2017
Date of last participant enrolment
Anticipated
Actual
24/02/2017
Date of last data collection
Anticipated
12/04/2017
Actual
8/05/2017
Sample size
Target
40
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 15464 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 295756 0
Government body
Name [1] 295756 0
Department of Industry, Innovation, Climate Change, Science, Research and Tertiary Education: Collaborative Research Network
Country [1] 295756 0
Australia
Funding source category [2] 295758 0
University
Name [2] 295758 0
University of Notre Dame Australia
Country [2] 295758 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
19 Mouat Street
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 294601 0
University
Name [1] 294601 0
Curtin University
Address [1] 294601 0
Kent Street,
Bentley, WA 6102
Country [1] 294601 0
Australia
Other collaborator category [1] 279456 0
Commercial sector/Industry
Name [1] 279456 0
Council on the Ageing WA
Address [1] 279456 0
The Perron Centre,
61 Kitchener Ave,
Perth WA 6100
Country [1] 279456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297055 0
University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 297055 0
Ethics committee country [1] 297055 0
Australia
Date submitted for ethics approval [1] 297055 0
05/09/2016
Approval date [1] 297055 0
03/10/2016
Ethics approval number [1] 297055 0
016155F

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

Contacts
Principal investigator
Name 72826 0
Dr Elissa Burton
Address 72826 0
University of Notre Dame Australia
Institute for Health Research
33 Phillimore Street,
Fremantle, WA 6959
Country 72826 0
Australia
Phone 72826 0
+61 8 9266 4926
Fax 72826 0
Email 72826 0
[email protected]
Contact person for public queries
Name 72827 0
Elissa Burton
Address 72827 0
University of Notre Dame Australia
Institute for Health Research
33 Phillimore Street,
Fremantle, WA 6959
Country 72827 0
Australia
Phone 72827 0
+61 8 9266 4926
Fax 72827 0
Email 72827 0
[email protected]
Contact person for scientific queries
Name 72828 0
Elissa Burton
Address 72828 0
University of Notre Dame Australia
Institute for Health Research
33 Phillimore Street,
Fremantle, WA 6959
Country 72828 0
Australia
Phone 72828 0
+61 8 9266 4926
Fax 72828 0
Email 72828 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

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