Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001161718
Ethics application status
Approved
Date submitted
15/10/2013
Date registered
21/10/2013
Date last updated
23/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of dual-task functional power training on falls in the elderly? An 18-month community-based randomised controlled trial
Scientific title
Effects of dual-task functional power training on falls in the elderly? An 18-month community-based randomised controlled trial
Secondary ID [1] 282613 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls prevention in the elderly 289307 0
Condition category
Condition code
Musculoskeletal 289642 289642 0 0
Other muscular and skeletal disorders
Public Health 289644 289644 0 0
Other public health
Neurological 290679 290679 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an 18-month randomised controlled trial involving 6-months of supervised dual task functional power training, a 6-month 'step-down' maintenance program, and a 6-month follow-up. Men and women at increased risk of falling will be randomised to: 1) Dual task functional power training plus a 6-month step-down program or 2) a usual care control group.

The dual task functional power training is an individually tailored high speed progressive resistance training program. The community based program will be supervised by accredited exercise trainers and conducted twice a week. Each session will last 45-60 minutes and consist of high velocity functional and resistance training with the goal to increase lower limb muscle power, including gait speed, movement speed and force, and mobility. Participants will be instructed to perform all repetitions for each concentric (shortening) phase of the exercise as quickly as possible, while the eccentric (lengthening) phase of the exercise action will be controlled over 3-4 seconds. The exercises will become progressively more challenging by increasing the difficulty or changing the exercise to another more complex task and adding a secondary task (such as counting backwards, or performing the exercise to the beat of the music). As a guide, participants will perform 2 sets of 10-20 repetitions progressing to 50 reps for the stepping exercises. For the resistance exercises, participants will perform 2 sets of 10-15 repetitions at an intensity of 4 to 6 (moderate to hard) on the 10 point Borg’s Rating of Perceived Exertion scale (RPE). Resistance will be increased as tolerated using this scale. Compliance to the exercise program will be monitored with exercise cards and session attendance records.
Intervention code [1] 287861 0
Prevention
Intervention code [2] 287862 0
Lifestyle
Comparator / control treatment
Participants allocated to the comparator group will receive their usual care (eg medication review, vision assessment) from their medical practitioner as required. They will also receive standardised falls prevention advice in the form of a booklet (Department of Health: Don’t fall for it – falls can be prevented) along with generic project newsletters that contain project updates to help minimise attrition over the 18-month study duration. There is no evidence that the provision of written falls prevention information alone reduces falls risk. We chose not to use a sham exercise control group as a secondary aim of this study is to evaluate the cost-effectiveness of the dual task functional power training.
Control group
Active

Outcomes
Primary outcome [1] 290398 0
Incidence of falls over the 18 months study via monthly falls calendars and telephone interviews
Timepoint [1] 290398 0
6 months, 12 months, 18 months
Secondary outcome [1] 304418 0
Lower extremity muscle power and strength via the 30-sec sit-to-stand and isometric knee extensor strength
Timepoint [1] 304418 0
baseline, 6 months, 12 months, 18 months
Secondary outcome [2] 304419 0
Functional Balance and Gait via the timed-up-and-go (TUG), four-square step test, the choice stepping reaction time, and the Zeno gait walkway under single and dual task conditions
Timepoint [2] 304419 0
baseline, 6 months, 12 months, 18 months
Secondary outcome [3] 304421 0
Fasted, resting morning blood samples will be collected to assess hormonal, inflammatory and neurotrophic related hormones and genetic markers related to cognitive function
Timepoint [3] 304421 0
baseline, 6 months, 12 months, 18 months
Secondary outcome [4] 304423 0
Neural excitability and inhibition assessed using Transcranial Magnetic Stimulation
Timepoint [4] 304423 0
baseline and month 1, 2, 3, 6 and 12
Secondary outcome [5] 304424 0
Health related quality of life (SF36 version 2), Activities of daily living, and general health assessed with validated questionnaires
Timepoint [5] 304424 0
baseline, 6 months, 12 months, 18 months
Secondary outcome [6] 304425 0
Cognitive function using the CogState computer program
Timepoint [6] 304425 0
baseline, 6 months, 12 months, 18 months
Secondary outcome [7] 304426 0
Fear of falling using the international Fall Efficacy Scale
Timepoint [7] 304426 0
baseline, 6 months, 12 months, 18 months
Secondary outcome [8] 305060 0
Cost-effectiveness analysis (monetary treatment costs of implementing the exercise program and cost of outcomes eg falls and their consequences)
Timepoint [8] 305060 0
After 6 and 12 months

Eligibility
Key inclusion criteria
Sedentary community dwelling men and women living in retirement villages or their own home who fulfill the defined criteria for an increased risk of falls (a score 3 or more on our falls risk assessment questionnaire); English speaking; and able to walk unaided or with minimal assistance for at least 50 metres.


Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded based on the following: 1) current participation in a progressive resistance or balance program; 2) acute or terminal illness likely to compromise exercise participation; 3) unstable or ongoing cardiovascular / respiratory disorders; 4) musculoskeletal or neurological diseases disrupting voluntary movement or that might limit training; 5) upper or lower extremity fracture in the past 3 months, and 6) visual impairment not corrected with glasses.

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)
Eligible participants will be invited from each retirement village to take part in the study. Participants may be referred to the study from a friend or by responding to local advertisements about the study within their retirement village or community centre. Eligible participants will then be screened further to ensure they fulfill the inclusion criteria for this study. All participants must receive approval from their local physician prior to participating in the program. Randomisation will be performed by cluster (village) stratified by village size, using a computer-generated random number sequence by an independent researcher not involved in the study. The assignment will be masked so that the investigators assessing outcomes will not be aware of the group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by cluster (village) to avoid any potential contamination and facilitate logistical arrangement. Each village will be given an ID number and group assignment by blocks, stratified by village size (<75 or =75 residents). Randomisation will be performed by an independent researcher not involved in the study using computer-generated random numbers (Microsoft Excel).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis will be conducted on an ITT basis using Stata. Where possible, we will obtain endpoint measures from all withdrawals and include all randomised subjects in the final analysis. The effect of the intervention on the primary outcome variables will be analysed using negative binomial models allowing for overdispersion. Unadjusted and adjusted analyses for potential covariates (and clustering) assessed at baseline will be conducted. The secondary outcome measures will be examined using General Linear Models allowing for the effects of clustering. Analysis of QoL (SF-36v2, AQoL6D) will utilize published ‘weightings’ most relevant to this population.


Sample Size Calculations: Based on data from Sanders et al and others,(Burnett et al 2003, Fitzharris et al 2010) we expect that ~45% of the usual care control group will experience a fall. We estimate that we will require 118 participants per group to detect a 40% lower rate of falls (eg. from 45% to 27%) in the dual task functional power training group with a two-tailed P value of 0.05 and power of 0.8. This allows for a 15% loss to follow-up due to death or withdrawal from the study based on our previous work. To account for cluster randomisation, we assumed a conservative intra-cluster correlation coefficient of 0.01, giving a design effect of 1.19, assuming 20 participants are recruited per village. This gives a sample size of 140 per group (280 participants from ~15 villages). This sample size will also provide sufficient power (0.9, two tailed, P<0.05) to detect significant and clinically meaningful differences in many of the secondary outcome measures.

The participant recruitment goal was increased from 280 to 310 to allow for an additional 10% dropout immediately following baseline testing and prior to the start of the intervention. However, only 300 participants were recruited within the defined timeframe.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2014
Actual
7/02/2014
Date of last participant enrolment
Anticipated
Actual
13/03/2015
Date of last data collection
Anticipated
Actual
14/12/2016
Sample size
Target
310
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287887 0
Government body
Name [1] 287887 0
National Health and Medical Research Council
Country [1] 287887 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood
Victoria, Melbourne, 3125
Country
Australia
Secondary sponsor category [1] 286613 0
University
Name [1] 286613 0
University of Newcastle
Address [1] 286613 0
University of Newcastle
School of Environmental and Life Sciences
10 Chittaway Road
Ourimbah
NSW 2258
Country [1] 286613 0
Australia
Secondary sponsor category [2] 286614 0
University
Name [2] 286614 0
University of Melbourne
Address [2] 286614 0
North West Academic Centre, University of Melbourne
Department of Medicine
Sunshine Hospital
PO Box 294
St Albans
VIC, 3021
Country [2] 286614 0
Australia
Secondary sponsor category [3] 286615 0
University
Name [3] 286615 0
Curtin University
Address [3] 286615 0
Curtin University
School of Physiotherapy
GPO Box U1987
Perth, WA 6845
Country [3] 286615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289828 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289828 0
Human Research Ethics
Deakin Research Integrity
Deakin University
221 Burwood Highway
Burwood
Victoria 3125

Country: Australia
Ethics committee country [1] 289828 0
Australia
Date submitted for ethics approval [1] 289828 0
Approval date [1] 289828 0
01/05/2013
Ethics approval number [1] 289828 0
2013-051

Summary
Brief summary
Falls are a major public health concern because they are associated with injury, pain, impaired function, loss of independence and even death. Reduced muscle power, or the ability to produce a rapid movement such as a quick step to recover from a loss in balance, is a strong predictor of disability and falls in older adults. In this population, the requirements to produce rapid movements often occurs whilst simultaneously performing other attention demanding cognitive-motor tasks such as walking while talking or negotiating obstacles. This study will evaluate whether a community-based, dual task functional power training (DT-FPT) program can reduce the rate of falls and improve risk factors for falls in elderly women at increased risk of falling. Secondary aims are to: 1) evaluate the efficacy of a 'step-down' maintenance program on fall rates; 2) assess the cost-effectiveness of the program; 3) evaluate the effects of the program on neural and cognitive health and function. This is an 18-month randomised controlled trial involving 6-months of supervised DT-FPT, a 6-month 'step-down' maintenance program, and a 6-month follow-up. Elderly women (n=300) at increased risk of falling will be randomised to: 1) DT-FPT plus a 6-month step-down program or 2) a usual care group. The primary outcome measure will be the number of falls throughout the study. Secondary outcomes will include: lower limb muscle power, gait, reaction time and balance under single and dual task conditions; falls related self efficacy, cognitive function and quality of life. All measures will be assessed at baseline, 6, 12 and 18 months. We expect that the results from this trial will guide the development and implementation of future community-based falls prevention programs that specifically focus on optimising muscle power, gait and function and reducing falls risk in the elderly under ‘real-life’ conditions. We also expect that the ‘step-down’ program will provide new information about the efficacy of a less intensive maintenance program for reducing the risk of falls over an extended period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40502 0
Prof Robin Daly
Address 40502 0
Deakin University
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Melbourne, Victoria, Australia 3125
Country 40502 0
Australia
Phone 40502 0
+61 3 9244 6040
Fax 40502 0
Email 40502 0
robin.daly@deakin.edu.au
Contact person for public queries
Name 40503 0
Dr Rachel Duckham
Address 40503 0
Deakin University
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Melbourne, Victoria, Australia 3125
Country 40503 0
Australia
Phone 40503 0
+61 3 9246 8286
Fax 40503 0
Email 40503 0
r.duckham@deakin.edu.au
Contact person for scientific queries
Name 40504 0
Prof Robin Daly
Address 40504 0
Deakin University
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Melbourne, Victoria, Australia 3125
Country 40504 0
Australia
Phone 40504 0
+61 3 9244 6040
Fax 40504 0
Email 40504 0
robin.daly@deakin.edu.au

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
EmbaseEffectiveness of dual-task functional power training for preventing falls in older people: study protocol for a cluster randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0652-y
EmbaseAssociations between inflammatory and neurological markers with quality of life and well-being in older adults.2019https://dx.doi.org/10.1016/j.exger.2019.110662
N.B. These documents automatically identified may not have been verified by the study sponsor.