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Trial registered on ANZCTR


Registration number
ACTRN12612000331831
Ethics application status
Approved
Date submitted
22/03/2012
Date registered
22/03/2012
Date last updated
22/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of the effect of a multi-sensory combined home and group based exercise programme on falls risk among community dwelling older people with depression
Scientific title
Among a group of older people with depressive symptoms does a high level group based exercise programme and a home based strength and balance programme have an impact on balance and falls risk when compared to a group receiving a group based and frequency matched sham programme?
Secondary ID [1] 280194 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk 286129 0
Depression 286130 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286320 286320 0 0
Physiotherapy
Mental Health 286325 286325 0 0
Depression
Injuries and Accidents 286326 286326 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the activity intervention group will be given home-based individual instruction in a physical activity programme and attend a group programme twice weekly for 4 weeks, both components of the intervention will focus on factors identified as being specific to falls risk among older people with depression. The home-based programme will be based on the Otago Exercise Programme, which comprises progressive moderate-intensity balance retraining, lower limb-strengthening exercises and walking. The participants will be encouraged to undertake the home based programme twice per week with visits from the research team twice in the first week to supervise the programme.
Participants will attend the group based programme twice per week for four weeks. There will be eight participants in each group. The programme will last for up to 90 minutes and will utilise different types of equipment balls, as tools to target sitting and standing balance control through the use of perturbation exercises that focus on the skill to recover balance and stepping reactions. The programme will constantly challenge the postural control system with exercises that incorporate elements related to the demands of normal activities of daily living. Such elements include single leg standing, weight transfer between feet, and change of support area as well as different reaching and bending movements of the trunk while standing and sitting. It will be based on principles shown to improve balance and stepping among older people at risk of falling. An experienced physiotherapist will be used to supervise all intervention group classes.
Intervention code [1] 284519 0
Rehabilitation
Intervention code [2] 284523 0
Prevention
Intervention code [3] 284526 0
Treatment: Other
Comparator / control treatment
Participants in the control group will attend a frequency matched group based sham seated exercise programme utilised in a previous study completed by members of the research team (Kerse, N., Campbell, J., Robertson, C., Taylor, D., Parsons, J., Woodley, S., Binns, E., Rosie, J. Preventing falls in residential care: targeted exercise or a multi-factorial programme? Accident Compensation Corporation; Wellington. 2009). The sham programme was designed as an active control to account for the amount of time each participant exercises in the intervention group based programme. The participants were not encouraged to undertake further exercise programmes at home.
Control group
Active

Outcomes
Primary outcome [1] 286790 0
Physiological Profile Assessment (PPA). The PPA is a valid and reliable tool for assessing fall risk in older people. Based on the performance of five physiological domains (vision, proprioception, strength, reaction time, and balance), the PPA computes a fall risk score.
Timepoint [1] 286790 0
Baseline and one month post randomisation
Secondary outcome [1] 296661 0
Attendance at sessions
Timepoint [1] 296661 0
Every group session
Secondary outcome [2] 296662 0
Mood as determined by Geriatric Depression Scale
Timepoint [2] 296662 0
Baseline and one month post randomisation

Eligibility
Key inclusion criteria
Participants from a previous trial (Depression and Exercise in Later Life [DeLITTE], n=193) (ANZCTR -ACTRN12605000667617) to determine the effect of physical activity among older people with depression living in the Auckland region undertaken by members of the research team will be contacted to ascertain their willingness to participate. The inclusion criteria for DeLITTE were: aged 77 years or older, community dwelling, able to communicate in English to complete assessments and that they had no severe dementia or unstable medical conditions precluding participation in a physical activity programme. All participants also showed a level of depressive symptoms on initial screening using a validated depression screening tool.
DeLITTE citations: Kerse, N., Peri, K., Robinson, E., Wilkinson, T., Randow, M., Kiata, L., Parsons, J., Latham, N., Parsons, M., and Willingale, J., Does a functional activity programme improve function, quality of life, and falls for residents in long term care? Cluster randomised controlled trial. British Medical Journal, 2008. 337(oct09 3): p. a1445.
Kerse, N., Hayman, K.J., Moyes, S.A., Peri, K., Robinson, E., Dowell, A., Kolt, G.S., Elley, C.R., Hatcher, S., Kiata, L., and Parsons, J., Home-Based Activity Program for Older People With Depressive Symptoms: DeLLITE-A Randomized Controlled Trial. The Annals of Family Medicine, 2010. 8(3): p. 214.
Minimum age
82 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe dementia (<7/10 on AMTS)
Severe or unstable cardiovascular disease (i.e. unstable angina, pacemaker fitted, dysrhythmia other than controlled atrial fibrillation)
Near-terminal disease (including advanced heart, lung, kidney, liver failure resistant to medical management)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants from the records of DeLITTE trial will be contacted by phone to determine their willingness to participate in the trial. If they agree then they will be visited by a research assistant and informed consent will be obtained. Following this the will be randomised. Randomisation will be ascertained by a randomisation schedule held at a distant site. (16 in intervention group and 16 control). This schedule will be compiled by someone with no involvement in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was generated using a through numeric list randomly generated within Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 4214 0
New Zealand
State/province [1] 4214 0
Auckland

Funding & Sponsors
Funding source category [1] 284941 0
University
Name [1] 284941 0
The University of Auckland
Country [1] 284941 0
New Zealand
Primary sponsor type
Individual
Name
John Parsons
Address
The Applied Ageing Research Group
School of Nursing, The University of Auckland
Faculty of Medical and Health Sciences
Level 2, Building 505, 85 Park Road, Grafton, Auckland, 1142,
Country
New Zealand
Secondary sponsor category [1] 283815 0
None
Name [1] 283815 0
Address [1] 283815 0
Country [1] 283815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286951 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 286951 0
Research Integrity Unit
Level 10, Building 620
49 Symonds Street
Auckland
1150
Ethics committee country [1] 286951 0
New Zealand
Date submitted for ethics approval [1] 286951 0
Approval date [1] 286951 0
08/09/2011
Ethics approval number [1] 286951 0

Summary
Brief summary
Falls are an important public health issue for older people, health providers and policy makers, as up to 35% of all older people fall every year and 68% of fallers sustain an injury. It has been shown that an effective method of reducing falls risk among older people is the provision of targeted and validated exercise programmes.
Older people with depressive symptoms are at an even higher risk of significant impairment in support balance reactions and a concomitant two times increased risk of falling and the development of associated disability than those without depressive symptoms. Consequently there is a need to also explore the effect on falls rates of exercise programmes that specifically target older people with depression. However, depression is associated with poor participation in physical activity programmes and so attention to choice and acceptability of activity is important to short-term and long-term sustainability for participants with depression.
This study will develop and test the effectiveness of an evidence based multi-sensory exercise programme among older people with depression. Using a randomised controlled trial design the combined home and group based programme will be compared to a frequency matched sham programme to explore the impact of the programme on physiological measures related to falls risk. In addition the safety and adherence to the programme will be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33961 0
Address 33961 0
Country 33961 0
Phone 33961 0
Fax 33961 0
Email 33961 0
Contact person for public queries
Name 17208 0
John Parsons
Address 17208 0
The Applied Ageing Research Group
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Level 2, Building 505, 85 Park Road, Grafton, Auckland, 1142, New Zealand
Country 17208 0
New Zealand
Phone 17208 0
+ 64 (0) 9 923 3935
Fax 17208 0
+ 64 (0) 9 367 7158
Email 17208 0
[email protected]
Contact person for scientific queries
Name 8136 0
John Parsons
Address 8136 0
The Applied Ageing Research Group
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Level 2, Building 505, 85 Park Road, Grafton, Auckland, 1142, New Zealand
Country 8136 0
New Zealand
Phone 8136 0
+ 64 (0) 9 923 3935
Fax 8136 0
+ 64 (0) 9 367 7158
Email 8136 0
[email protected]

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