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Trial registered on ANZCTR


Registration number
ACTRN12619000430134
Ethics application status
Approved
Date submitted
12/03/2019
Date registered
15/03/2019
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Date results information initially provided
15/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Staying UpRight in Rest Home Care Trial
Scientific title
Fall prevention in residential care: a pilot study of a multifactorial and an activity programme
Secondary ID [1] 297473 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 311665 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310287 310287 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design is a 2x2 Factorial study; the 4 arms of the study being
1) Usual care facility with Flex and Stretch (control) exercise programme
b) Usual care facility with Staying UpRight exercise programme
c) Multifactorial programme facility with Flex and Stretch (control) exercise programme
d) Multifactorial programme facility with Staying UpRight programme


Facility level intervention
Multifactorial falls prevention intervention consisted of a training programme for a falls champion. Resources and training given to the champion were taken form Australian Commission on Safety and Quality in Health Care (with their permission in 2008) and included: environmental audit, risk assessment information, fact sheets for nurses doctors, caregivers, allied health professionals and managers, a DVD of case studies for caregivers, best practice guidelines, an implementation guide for a falls prevention and management programme, and a training package for caregivers. Hip protectors were supplied free of charge for all enrolled residents in multifactorial homes, and Vitamin D was recommended for all, with GP support obtained.
The training was delivered face to face at a one day training session by members of the research team and included registered nurses and registered physiotherapists. Ongoing telephone support and face to face meetings (as required) continued through out the 6 month intervention period.
Resident level intervention
The UpRight exercise programme consisted of strength, balance, sensory integration and dual tasking exercises, progressing over time. The class was delivered by a physiotherapist in two sessions of one hour each per week over a 6 month period in the recreation room in the Residential Aged Care facility in which the participant lived. Exercises examples: be Hip extension in standing holding onto the back of a chair with both hands, progressing to one had, progressing to not holding on at all; Knees bends in standing holding onto the back of a chair with both hands, progressing to one had, progressing to not holding on at all;Triceps chair press up
The physiotherapists attended a one day face to face training session on how to deliver the Staying UpRight and Flex and Stretch classes and received a manual which detailed the proposed structure of both classes, attendance sheets and an excel template on which to plan and record the Staying UpRight class. Classes were twice a week for an hour each time.
The physiotherapist completed attendance sheets for each Staying UpRight and Flex and Stretch class and returned them to the research team at the end of each month.

Intervention code [1] 313727 0
Prevention
Comparator / control treatment
Facility level intervention
Usual care
The Residential Aged Care facilities randomised to usual care continued as they normally would (the research team had no input into the running of the facility).
Resident level intervention
The Flex and Stretch class was dose matched to the Staying UpRight classes and comprised of only seated exercises where segments of the body were taken through a range of movement and class game-like activities.
Control group
Active

Outcomes
Primary outcome [1] 319182 0
Class attendance (as a proxy for participant acceptance of the class to which they were randomised)
Timepoint [1] 319182 0
After completion of the 6 month intervention period
Secondary outcome [1] 367207 0
Response rate of Residential Aged Care facilities and residents to invitation to take part in the study
Timepoint [1] 367207 0
At completion of recruitment
Secondary outcome [2] 367208 0
Short Performance Physical Battery
Timepoint [2] 367208 0
After completion of the 6 month intervention period
Secondary outcome [3] 367209 0
Falls rate (falls per person year. Audit of Residential Aged Care facility falls register by a blinded member of the research team for the 6 months period of the intervention.
Timepoint [3] 367209 0
After completion of the 6 month intervention period

Eligibility
Key inclusion criteria
To identify residential aged care facilities
The sampling was from a list of residential aged care facilities in the Waitemata District Health Board area.
Residents
65 years or older, living in residential aged care, mobile with or without an assistive device.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Facilities
All private hospitals for continuing care, facilities under 20 beds and facilities already running the Life Programme, which incorporates an activity programme, were excluded.
Residents
Were excluded if they were under 65 years, were admitted for palliative care, respite care, at their registered nurse’s or clinical nurse coordinator’s discretion, if they were unable to give informed consent and relatives were uncontactable to do so on their behalf, or if they were not in the facility at the time(s) of recruitment.

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)
The schedule for random allocation of individual participants to exercise or control classes, and random allocation of residential care facilities to the multifactorial intervention or to act as a control for this intervention, was computer generated and held by an investigator at a distant site who was not involved in the day to day running of the trial. After baseline assessments had been completed, the investigator sent the physiotherapist the allocation list for the participants at that rest home. After all study recruitment and baseline assessments had been completed, the allocation schedule for the multifactorial intervention (residential aged care facility) was sent to the study co-ordinator so that this intervention could be implemented in two of the four rest homes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generated by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Sample size: A sample size of 33 participants in each group will provide a power of 80% at 5% alpha level to detect a 20% improvement in sit-to-stand performance. This is based on a normative score in this population of 12 ± 4 repetitions for the 30-second chair-stand test.
Analysis: The main outcome measure, the feasibility of delivering the interventions is defined as 1) evidence that the multi-faceted intervention is acceptable to staff, 2) that the champion can increase awareness of falls and complete the multifaceted intervention, 3) if participation in the exercise programme is over 70% per session, and 4) staff and residents find the exercise programme acceptable. Regression analyses using generalised linear mixed models which take into account the covariance pattern of the data will be used to investigate changes over time in the functional outcomes, and whether these changes differ between the exercise intervention and control groups

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21293 0
New Zealand
State/province [1] 21293 0
Auckland

Funding & Sponsors
Funding source category [1] 302042 0
Government body
Name [1] 302042 0
Accident Compensation Corporation
Address [1] 302042 0
Justice Centre. 19 Aitken Street. Wellington 6140.
Country [1] 302042 0
New Zealand
Primary sponsor type
Individual
Name
Prof Ngaire Kerse
Address
Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland1001,
Country
New Zealand
Secondary sponsor category [1] 301850 0
Individual
Name [1] 301850 0
Prof Denise Taylor
Address [1] 301850 0
Health & Rehabilitation Research Centre
School of Rehabilitation & Occupation Studies, Akoranga Campus,
AUT University
Private Bag 92006, Auckland 1142,
Country [1] 301850 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302725 0
Health and Disability Ethics Committee
Ethics committee address [1] 302725 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302725 0
New Zealand
Date submitted for ethics approval [1] 302725 0
Approval date [1] 302725 0
27/05/2008
Ethics approval number [1] 302725 0

Summary
Brief summary
Falls are a major public health issue for older people, and those in residential care falls most frequently and are at the highest risk for injury from falls. Costs related to fall and injury management are disproportionately spent in residential care. There is little evidence that exercise alone is effective in residential care and some trials show an increase in falls as a result of exercise. Multifactorial programmes do not consistently reduce falls in residential care, however exercise seems to be a necessary component in those that have been successful. A promising exercise programme has been developed based on the Otago Exercise Programme and a successful programme used in Germany as part of a mulitfactorial intervention has been adapted for New Zealand use. It would be of great benefit to know whether exercise, delivered as a single intervention, is more or less effective than a multifactorial facility based intervention, or whether the combination of the two is better than each delivered individually. This study aims:
1) To refine an exercise programme aimed at preventing falls in residential care and test its effect on strength and balance (impairments of these two biological parameters are closely related to an increased risk of falls)
2) To establish feasibility for a large 2x2 factorial randomised controlled trial that will test the question “Does a multifactorial programme reduce falls in New Zealand rest homes or is an exercise programme alone sufficient to reduce falls?”
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91170 0
Prof Ngaire Kerse
Address 91170 0
Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland 1001
Country 91170 0
New Zealand
Phone 91170 0
+64 9 9234467
Fax 91170 0
Email 91170 0
n.kerse@auckland.ac.nz
Contact person for public queries
Name 91171 0
Prof Ngaire Kerse
Address 91171 0
Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland 1001
Country 91171 0
New Zealand
Phone 91171 0
+64 9 9234467
Fax 91171 0
Email 91171 0
n.kerse@auckland.ac.nz
Contact person for scientific queries
Name 91172 0
Prof Ngaire Kerse
Address 91172 0
Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland 1001
Country 91172 0
New Zealand
Phone 91172 0
+64 9 9234467
Fax 91172 0
Email 91172 0
n.kerse@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At the time ethical approval was granted for this pilot study, the standard requirement for data storage was 10 years. It is now more than 10 years after the study was completed and hard copy data files have been shredded and destroyed and electronic files deleted.
What supporting documents are/will be available?
Clinical study report
How or where can supporting documents be obtained?
Type [1] 1429 0
Clinical study report
Citation [1] 1429 0
Link [1] 1429 0
Email [1] 1429 0
Other [1] 1429 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 1430 0
Presentation
Citation/DOI/link/details [1] 1430 0
Plenary session at the 4th Australian and New Zealand Falls Prevention Society Conference, Dunedin, New Zealand, 2010 (PowerPoint presentation the last 2 slides before the concluding slide)
https://www.otago.ac.nz/fallsconference/ANZFPS%20Conference%20Kerse%20Plenary%201.pdf

Attachments [1] 1430 0
Results – plain English summary
Four Residential Aged Care facilities and 68 residents took part in the study. During the trial 14 participants died or were transferred out of the Residential Aged Care facility. Average attendance at the UpRight exercise classes was 60% of the available classes and 55% of available Flex and Stretch classes.
Overall, there was no impact of the UpRight classes on the functional mobility measures of the residents apart from 10 people improving their time to walk 10 metres in the UpRight group compared with 4 in the Flex and Stretch group. Considering the impact of the multifactorial programme, there was a significant increase in the number of residents using Vitamin D in intervention Residential Aged Care facilities compared with the control Residential Aged Care facilities (96% vs 56% respectively) and more people in intervention homes were wearing hip protectors at follow up (23% in intervention Residential Aged Care facilities vs none in control Residential Aged Care facilities). There was no difference in fall rates between groups.