Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000700639
Ethics application status
Approved
Date submitted
24/06/2014
Date registered
3/07/2014
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Active ageing: a novel dynamic exercise initiative for older people to improve health and well being - a study protocol.
Scientific title
In people aged between 60 and 90 years old, can an intervention using an exercise park specifically designed for seniors (compared to not using this specific senior exercise park), reduce their falls risk?
Secondary ID [1] 284857 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk in older people
 292255 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292598 292598 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 292659 292659 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Park Intervention Group (EPIG)
Participants from the EPIG will undergo an 18 weeks exercise intervention. The exercise sessions will be provided 2-3 times a week (each class approximately 1 to 1.5 hours duration) and it will be supervised by a qualified physiotherapist or an accredited exercise physiologist.

The exercise classes will include 6-8 participants and will be circuit-based with the warm up and cool down exercises being performed in a group and the core session being carried out in training pairs.

Participants will be performing a series of exercises such as sit to stand, calf raises+climbing finger steps, climbing stairs, walking up and down a ramp, walking on a balance beam, balancing on a gangway, taps on a platform, etc.

To measure the intensity of the exercises, we will be using 10-point Rate of Perceived Effort (RPE) Scale. Participants will be encouraged to progress the exercises to the next level if they rate the exercise intensity below 4/10. We will encourage them to exercise with a RPE between 4 and 7/10.

Participants from EPIG will be tested at the following timelines: at baseline, after 18 weeks and after 2 months.
Intervention code [1] 289656 0
Prevention
Intervention code [2] 289696 0
Lifestyle
Comparator / control treatment
Control Group (CG)
Participants in the CG will be advised to continue with their daily usual activities and will be meeting the research team every 2 weeks to take part in some social activities (9 meetings over 18 weeks of intervention). These social meetings will last for 3 hours (each session). Participants will participate in a range of social activities such as bingo game, board games, card games, dance classes, craft classes, etc.

Participants from CG will be tested at the following timelines: at baseline, after 18 weeks and after 2 months.
Control group
Active

Outcomes
Primary outcome [1] 292449 0
BOOMER Balance Test
The Balance Outcome Measure for Elder Rehabilitation (BOOMER) consisted of the step test, Timed Up & Go test, Functional Reach Test, and static standing with feet together and eyes closed test.
Timepoint [1] 292449 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [1] 308980 0
Physical and Physiological Secondary Outcomes Hand grip strength test: the strength of the hand grip using a TTM digital hand dynamometer (Mentone Educational Centre, Melbourne, VIC).
Timepoint [1] 308980 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [2] 309115 0
2 min walk test: this test will be used to assess exercise tolerance.
Timepoint [2] 309115 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [3] 309116 0
Sit to stand test: this test will be used to measure mobility and lower limb strength and is also included in fall risk assessments.
Timepoint [3] 309116 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [4] 309117 0
Knee extensor muscle strength test: to measure lower limb strength. This test will use a Victoria University built force transducer.
Timepoint [4] 309117 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [5] 309118 0
Spatio-Temporal Parameters Measures of stride dynamics and gait variability have been shown to identify fallers in older adults with gait limitations and those with a history of falls. Assessment of walking speed, stride length, stride width and double limb support will be performed with the use of the GaitRite (Registered Trademark) system (CIR System, Inc, Harverton PA) instrumented walkway system.
Timepoint [5] 309118 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [6] 309119 0
The Short Form 12 (SF-12) Health Survey: This questionnaire evaluates the individual health status over eight domains including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Timepoint [6] 309119 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [7] 309120 0
The Incidental and Planned Activity Questionnaire (IPAQ) for older people: This questionnaire will be used to assess the physical activity level of the participants.
Timepoint [7] 309120 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [8] 309121 0
The Falls Efficacy Scale (Short FES-I): This questionnaire will be also used to record fear of falling.
Timepoint [8] 309121 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [9] 309122 0
Social activity participation: Participants will be asked to record the number of times in the previous 2 weeks that they have participated in 10 categories of social activities, for example: gone to church, visiting friends and family, gone to concerts, plays, or sporting events. This 10-item questionnaire was derived from a measure of social functioning and has been previously used to measure social participation in people who had repeated falls.
Timepoint [9] 309122 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [10] 309123 0
Physical Self Description Questionnaire (PSDQ): This questionnaire will be used to measure the physical self-perception of the participant.
Timepoint [10] 309123 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [11] 309124 0
Falls and Physical Activity Calendar Participants record any falls and physical activity or exercise experienced for the duration of the study using a monthly calendar.
Timepoint [11] 309124 0
Baseline, and at 18 and 26 weeks after intervention commencement.
Secondary outcome [12] 313732 0
Feasibility: the feasibility will be assessed and will be defined as the number of participants recruited and retained over the recruitment period, overall adherence and seasonal adherence, safety and adverse effects and number of sessions cancelled due to unfavourable weather conditions. In addition, the qualitative data collected via interviews of EPIG participants will be taken into account for feasibility purposes as they might more clearly show participants’ perceptions of this kind of initiative.
Overall adherence to the exercise program will be defined by the number of sessions attended: 100% adherence if participant attended 35 sessions or 9 sessions of social meetings. EPIG or CG participants’ participation and attendance will be recorded via a spreadsheet diary and will be collected respectively by the exercise supervisor of that participant on each specific session or by the principal researcher. Physical activity calendars will be used to monitor if EPIG or CG participants have participated in any other physical activities during their participation in the study. Reasons for participants missing sessions will be documented on the spreadsheet diary. Participants will be given a phone call in case they miss two consecutive sessions without any communication with any exercise supervisors.
Seasonal adherence will be recoded as adherence over Summer (December to end of February), Fall (March to end of May), Winter (June to end of August) and Spring (September to end of November). Also, the number of sessions that were cancelled due to rainy, windy and excessively hot days (above 37 degrees Celsius) will be recorded given that these conditions would potentially put participant’s safety and health in risk.
Safety and adverse effects will be measured by the number of falls incidents occurred during exercise sessions and it will be recorded via an incident report form (treatment needed post-incident and related lesions or injuries). The circumstances surrounding the fall (e.g. muscle fatigue, dizziness,) will be recorded. EPIG participants will be also asked in the following session (48 hours) to report if they experienced any uncomfortable delayed muscle soreness or fatigue post-exercise that refrained them from doing their daily tasks such as coming up and down stairs, rising from a chair, and carrying shopping bags. The following question will be used: “Did you experience any muscle soreness after the session that refrained you from doing your normal daily activities such as carrying shopping bags, rising from a chair or putting a t-shirt on?”. If they answer “yes” the muscle soreness event will be recorded on the participant’s spreadsheet diary.
Timepoint [12] 313732 0
The feasibility measure will be measured after the conclusion of the data collection and analysis .
Secondary outcome [13] 313733 0
Qualitative Data: Participants allocated to EPIG will be interviewed by an experienced qualitative researcher at the end of the intervention period (18 weeks). This interview will explore the participant’s experience with the project including reasons to volunteer to the project and their experiences with the training program (staff supervision, frequency, duration, progression of exercises, level of difficulty, changes to their life in general and general level of satisfaction). Only participants assigned to the exercise intervention group will be interviewed. In interviewing these participants, we aim to be able to identify the positive and negative elements of the exercise park program perceived by the participants, as well as the main participation barriers which can impact on the adherence and acceptability of the intervention. The interviews will be conducted on an individual basis by a researcher independent to the intervention. All interviews will be digitally recorded and transcribed verbatim. The interviews will be analysed using a thematic analysis approach.
Timepoint [13] 313733 0
The qualitative data is going to be collected at the end of the intervention period (18 weeks) and only participants allocated to EPIG group will be interviewed.

Eligibility
Key inclusion criteria
Participants who have had one fall in the previous 12 months or are concerned about having a fall will be recruited.
Participants who are generally active and independent in the community with no more than a single point stick used for regular outdoors walking (at least 3 times per week) will be included.
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Older adults will be excluded from this study if they have:
a) any uncontrolled non-musculoskeletal conditions that would make testing difficult and uncomfortable, such as chronic obstructive airways disease and congestive heart failure;
b) a pre-existing neurological or orthopaedic condition that affects lower limb strength (e.g.: polio, stroke);
c) Any of the following foot conditions: partial foot amputation or ulceration or food fractures;
d) Any musculoskeletal conditions that may affect the ambulation (rheumatoid arthritis, gout, etc).
Participants with any documented medical condition or physical impairment that is judged by the medical practitioner to contraindicate their inclusion will be excluded.
Older people with some medical history but controlled conditions will not need medical clearance to participate in this study.
Participants with heart problems will be required to get a medical clearance for their GP in order to participate in this study.

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)
Participants will be recruited from Melbourne suburbs. Local senior organizations, retirement villages, community centres, senior clubs and associations in the areas around the park location will be contacted for recruitment purposes. Participants will be also recruited via community health promotion events and advertisement in local newspapers, magazines and online social networking media. Participants will be informed about the project by posters placed in healthcare facilities and places with high circulation of senior citizens and mail-out advertisements to health care practitioners in Melbourne. Participants will be randomly allocated to one of the following groups: (1) Exercise Park Intervention Group (EPIG) or (2) Control Group (CG). Block randomization stratification by gender will be undertaken, so that blocks of 12 participants will be recruited at a time, randomized into one control group of six participants and one exercise groups of six participants (Figure 1). To accommodate couples (e.g. partners/married couples) participation, randomisation by couple will also take place. Six paper codes (three exercise intervention and three control group) will be added to opaque not concealed envelopes. There will be three envelopes: one for couples, one for females and one for males. Participants will be asked to pick one paper from their respective envelope and the picked paper will assign the participant to either the exercise intervention group or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization with stratification by gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. If there are chance imbalances in baseline participants’ characteristics, then these variables will be used as covariates.

Mixed linear modelling incorporating intervention and control groups at the baseline and two follow up time points (18 weeks and 26 weeks after intervention commencement), with the number of sessions attended and baseline physical activity level as covariates, will be carried out using SPSS. Comparisons will be made for the primary outcome (BOOMER) and secondary outcomes (functional tasks, strength measures, gait parameters, health related quality of life measures, and psychosocial measures). Although the number of falls is being recorder over a period of 12 months after the commencement of participants, this study is not powered for falls outcomes. Regarding the qualitative data being collected, the interviews from EPIG participants will be analysed using a thematic analysis approach. Both an inductive and deductive approach to data analysis will be used to identify themes.


Power analysis was undertaken using previously published discharge data on the primary outcome measure - the BOOMER balance measure, and assuming an improvement of 3 points (reported as the minimum detectable difference) and an effect size of 0.5. A sample size of 48 participants per group is required for a power of 0.80 and alpha of 0.05. We will allow for 20% dropout rate (this is a conservative estimate based on previous exercise programs with older people), and therefore will recruit 60 participants per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
6/01/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
27/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289470 0
Charities/Societies/Foundations
Name [1] 289470 0
Gandel Philanthropy
Country [1] 289470 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 288203 0
None
Name [1] 288203 0
Address [1] 288203 0
Country [1] 288203 0
Other collaborator category [1] 278014 0
Other Collaborative groups
Name [1] 278014 0
Catholic Homes
Address [1] 278014 0
2 Domville Ave, Hawthorn VIC 3122
Country [1] 278014 0
Australia
Other collaborator category [2] 278015 0
Other Collaborative groups
Name [2] 278015 0
Gateway Social Support Options
Address [2] 278015 0
43 Paxton St, South Kingsville VIC 3015
Country [2] 278015 0
Australia
Other collaborator category [3] 278016 0
Commercial sector/Industry
Name [3] 278016 0
Lappset Australia Pty Ltd
Address [3] 278016 0
PO Box 524. Templestowe VIC 3106
Country [3] 278016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291227 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 291227 0
Ethics committee country [1] 291227 0
Australia
Date submitted for ethics approval [1] 291227 0
Approval date [1] 291227 0
16/10/2013
Ethics approval number [1] 291227 0
HRE13-215

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

Contacts
Principal investigator
Name 49414 0
Mrs Myrla Sales
Address 49414 0
Victoria University
PO Box 14428
Melbourne, VIC 8001
Country 49414 0
Australia
Phone 49414 0
+61432715653
Fax 49414 0
Email 49414 0
[email protected]
Contact person for public queries
Name 49415 0
Myrla Sales
Address 49415 0
Victoria University
PO Box 14428
Melbourne, VIC 8001
Country 49415 0
Australia
Phone 49415 0
+61432715653
Fax 49415 0
Email 49415 0
[email protected]
Contact person for scientific queries
Name 49416 0
Pazit Levinger
Address 49416 0
Victoria University
PO Box 14428
Melbourne, VIC 8001
Country 49416 0
Australia
Phone 49416 0
+61399195525
Fax 49416 0
Email 49416 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
EmbaseA novel dynamic exercise initiative for older people to improve health and well-being: study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s12877-015-0057-5
EmbaseA Novel Exercise Initiative for Seniors to Improve Balance and Physical Function.2017https://dx.doi.org/10.1177/0898264316662359
N.B. These documents automatically identified may not have been verified by the study sponsor.