Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000348651
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
1/04/2014
Date last updated
25/06/2019
Date data sharing statement initially provided
25/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Fun 'n Fitness Exercise Program (Falls Prevention Program)
Scientific title
Exercise for balance: A randomised controlled trial to evaluate the safety, feasibility, efficacy and mediators of group exercise to reduce falls in aged care
Secondary ID [1] 284227 0
Nil known
Universal Trial Number (UTN)
U1111-1154-3347
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High falls risk 291341 0
Cognitive impairment 291342 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291703 291703 0 0
Physiotherapy
Injuries and Accidents 291704 291704 0 0
Other injuries and accidents
Neurological 291705 291705 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will evaluate a group exercise program that aims to prevent falls and improve balance among residents of Churches of Christ run aged care facilities in Queensland.

Study design
The study is designed as a single-blinded 12-month cluster randomized controlled trial.

Centres and Participants
Churches of Christ (CofCQLD) operates 18 residential aged care facilities in Queensland. The 14 centres with more than 25 residents each will be involved in this study. The centres will be matched pair wise according to number of residents and low/high care ratio; from each pair, one centre will be allocated to the intervention group and one centre will be allocated to the control group using a blinded randomisation procedure. Randomisation will take place after completion of baseline testing. Sample size calculations showed that over 600 participants are needed to detect statistically significant differences in falls risk; the total number of residents in these 14 sites is 1103.

Intervention group
Participants will be invited to attend twice weekly, 30-45 min group exercise sessions within the premises of the residential aged care facility for a 12 month period. The sessions are led by lifestyle coordinators and supervised by a physiotherapist. The sessions involve a range of group-based exercises designed to incorporate all the major components that are found to support and manage fall risks among older people, including strength, balance, fitness/endurance, and gait. Further falls prevention strategies incorporated within the program include dual-tasking, enhancement of speed of reaction and the ability to take that step to regain balance, and bodily coordination. The program is designed to allow participants of all ability levels to participate and be challenged whilst encouraging and supporting each other. Examples of exercises include:
- Range of motion and stretching in warm up and cool down
- Variations in standing balance – chair support, side stepping, weight shift, arm movements
- Sit to stands – slow and faster; skier’s exercise
- In chair exercises at fast pace for upper and lower limbs to challenge cardiovascular fitness
- Coordination – throwing and catching balls, eyes follow and finger-to-nose movements
- Speed of reaction using coloured boards – pointing to correct colour on boards with foot as called by leader at speed
Intervention code [1] 288935 0
Lifestyle
Intervention code [2] 289081 0
Prevention
Comparator / control treatment
Control group
The control group will receive usual care. As participants who are receiving structured muscle strengthening and balance training similar to those in the exercise program will be excluded from the study, usual care for our participants is not likely to involve structured supervised exercise.
Control group
Active

Outcomes
Primary outcome [1] 291641 0
Falls, defined as (i) proportion of fallers, (ii) the number of falls, (iii) number of injurious falls, and (iv) time to each fall.

The dates of each fall as well as details surrounding each fall will be extracted from the centres incidents database. Falls are recorded centrally by each centre as part of standard procedure. This information will be given to the researchers monthly during the intervention as well as for the 12 months after the end of the intervention to assess sustainability of the intervention effect.
Timepoint [1] 291641 0
At baseline and 12 and 24 months following baseline
Secondary outcome [1] 307217 0
Physical functioning

A battery of functional performance tests will be used to assess mediators of fall risk - including muscle strength (repeated chair stand test), balance (four-test balance scale and sway-meter), and usual walking speed (6-metre walk test) under single (usual walking) and dual tasking (naming animals and subtracting serial 7s). Grip strength will also be tested as a measure of upper body strength. Prior to these tests a demonstration of each test will be given by the tester. Functional performance measures will be conducted in a standardised order and with appropriate rest periods between trials.
Timepoint [1] 307217 0
At baseline and again 6 weeks, 12 weeks, 6 months, 12 months following baseline testing
Secondary outcome [2] 307218 0
Well-being

Physical and mental well-being will be assessed with the Dementia Quality of Life Questionnaire (DQoL).
Timepoint [2] 307218 0
At baseline and again 6 weeks, 12 weeks, 6 months, 12 months following baseline testing

Eligibility
Key inclusion criteria
Participants are Churches of Christ Queensland residents from aged care centres aged 65 years and older.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents will be excluded from participating in the trial if they: (i) are confined to their bed or are wheelchair dependent at all times, (ii) are unable to stand or remain standing unaided, or (iii) have any medical conditions (musculoskeletal, cardiopulmonary or metabolic) that would prevent their safe participation in the exercises program. Residents will also be excluded if they have been receiving regular (1 or more times per week on average) physiotherapy or exercise therapy that involves balance and/or muscle strengthening exercises similar to those included in the intervention during the past 6 months or anytime during the intervention period.

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)
(i) During information sessions for Churches of Christ Queensland (CofCQLD) staff at each of the sites, the aim and protocol of the study will be explained. All queries from staff will be addressed.
(ii) Local CofCQLD staff will assist with recruitment by providing names of residents meeting inclusion criteria and these residents and their relatives or power of attorney and/or statutory health guardian will be contacted by project staff to explain the study and consent procedure. Oral and written information will be provided.
(iii) If willing to participate, the residents and their relatives or power of attorney and/or statutory health guardian will be asked to sign informed consent.

Churches of Christ (CofCQLD) operates 18 residential aged care facilities in Queensland. The 14 centres with more than 25 residents each will be involved in this study. The centres will be matched pair wise according to number of residents and low/high care ratio; from each pair, one centre will be allocated to the intervention group and one centre will be allocated to the control group using a blinded randomisation procedure. Allocation concealment was performed via central randomisation by a computer.

Randomisation will take place after completion of baseline testing. Sample size calculations showed that over 600 participants are needed to detect statistically significant differences in falls risk; the total number of residents in these 14 sites is 1103.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Safety/efficacy
Statistical methods / analysis
Sample size calculations showed that, with a significance level of 0.05, a power of 80%, an intra-class-correlation of 0.07 to adjust for the clustering effect, an annual fall rate of 60% in the control group, and an expected 30% reduction in proportion of fallers in the intervention group, 250 participants would be needed per group. Taking into account a drop-out rate of 25%, a minimum of 313 participants per group should be high enough to detect statistically significant differences.

The proportions of fallers will be compared between the intervention and control groups. Group differences in number of falls and number of injurious falls will be tested using Cox Proportional Hazards models with extension for multiple events. This analysis allows inclusion of the number of falls as well as the time to each fall resulting in optimal power. Potential effect modification of baseline cognitive and physical functioning will be tested; if significant, the results will be presented for the relevant subgroups. Differences in pre-post intervention scores on measures of physical function and quality of life will be compared between the intervention and control groups using multi-level regression analyses. To examine which factors mediate the program’s effectiveness, structured equation modelling will be used to model the effect of each of the potential mediators on the fall risk.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
28/03/2014
Actual
28/03/2014
Date of last participant enrolment
Anticipated
26/03/2018
Actual
23/03/2015
Date of last data collection
Anticipated
Actual
24/11/2015
Sample size
Target
600
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288857 0
University
Name [1] 288857 0
School of Human Movement Studies, The University of Queensland Strategic Seed Funding
Country [1] 288857 0
Australia
Primary sponsor type
Individual
Name
Dr Tina Skinner
Address
School of Human Movement Studies (#26B), Room 520
Cnr Blair Drive & Union Road
The University of Queensland, St Lucia Campus
Brisbane Qld 4072
Country
Australia
Secondary sponsor category [1] 287552 0
Individual
Name [1] 287552 0
Dr Geeske Peeters
Address [1] 287552 0
School of Human Movement Studies (#26B)
Cnr Blair Drive & Union Road
The University of Queensland, St Lucia Campus
Brisbane Qld 4072
Country [1] 287552 0
Australia
Secondary sponsor category [2] 287553 0
Commercial sector/Industry
Name [2] 287553 0
Churches of Christ Queensland
Address [2] 287553 0
Churches of Christ in Queensland
41 Brookfield Rd. Kenmore QLD 4069
P.O. Box 508 Kenmore QLD 4069
Country [2] 287553 0
Australia
Secondary sponsor category [3] 287581 0
Individual
Name [3] 287581 0
Carmela Lagasca
Address [3] 287581 0
Churches of Christ in Queensland
41 Brookfield Rd. Kenmore QLD 4069
P.O. Box 508 Kenmore QLD 4069
Country [3] 287581 0
Australia
Secondary sponsor category [4] 287582 0
Individual
Name [4] 287582 0
Delma Glindemann
Address [4] 287582 0
Lady Small Haven Aged Care Service
Churches of Christ Care
60 Allchurch Avenue Benowa QLD 4217
Country [4] 287582 0
Australia
Other collaborator category [1] 277864 0
Individual
Name [1] 277864 0
Sandy Brauer
Address [1] 277864 0
School of Health & Rehabilitation Sciences
Therapies Annexe Building 84
Level 8, Room 805
The University of Queensland, Brisbane, QLD 4072
Country [1] 277864 0
Australia
Other collaborator category [2] 277865 0
Individual
Name [2] 277865 0
Susan Tett
Address [2] 277865 0
School of Pharmacy, The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country [2] 277865 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290689 0
Medical Research Ethics Committee
Ethics committee address [1] 290689 0
Ethics committee country [1] 290689 0
Australia
Date submitted for ethics approval [1] 290689 0
Approval date [1] 290689 0
13/02/2014
Ethics approval number [1] 290689 0
2014000043

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

Contacts
Principal investigator
Name 46806 0
Dr Tina Skinner
Address 46806 0
School of Human Movement Studies (#26B), Room 520
Cnr Blair Drive & Union Road
The University of Queensland, St Lucia Campus
Brisbane Qld 4072
Country 46806 0
Australia
Phone 46806 0
+61 7 3346 8810
Fax 46806 0
Email 46806 0
[email protected]
Contact person for public queries
Name 46807 0
Carmela Lagasca
Address 46807 0
Churches of Christ in Queensland
41 Brookfield Rd. Kenmore QLD 4069
P.O. Box 508 Kenmore QLD 4069
Country 46807 0
Australia
Phone 46807 0
+61 7 3363 1755
Fax 46807 0
Email 46807 0
[email protected]
Contact person for scientific queries
Name 46808 0
Geeske Peeters
Address 46808 0
School of Human Movement Studies (#26B)
Cnr Blair Drive & Union Road
The University of Queensland, St Lucia Campus
Brisbane Qld 4072
Country 46808 0
Australia
Phone 46808 0
+61 7 3346 9999
Fax 46808 0
Email 46808 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
IPD will not be available for this trial as this was not approved by the Human Research Ethics Committee at the time of participant enrolment. Grouped data will be available through peer reviewed publication, with further details regarding the study protocol, statistical plan, informed consent form and ethical approval available on request.


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.