ANZCTR - Registration

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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Falls

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

Class attendance (as a proxy for participant acceptance of the class to which they were randomised)

Timepoint [1]

After completion of the 6 month intervention period

Secondary outcome [1]

Response rate of Residential Aged Care facilities and residents to invitation to take part in the study

Timepoint [1]

At completion of recruitment

Secondary outcome [2]

Short Performance Physical Battery

Timepoint [2]

After completion of the 6 month intervention period

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

5/06/2008

Date of last participant enrolment

Anticipated

Actual

15/07/2008

Date of last data collection

Anticipated

Actual

11/03/2009

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Accident Compensation Corporation

Address [1]

Justice Centre. 19 Aitken Street. Wellington 6140.

Country [1]

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]

Individual

Name [1]

Prof Denise Taylor

Address [1]

Health & Rehabilitation Research Centre
School of Rehabilitation & Occupation Studies, Akoranga Campus,
AUT University
Private Bag 92006, Auckland 1142,

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

27/05/2008

Ethics approval number [1]

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

Prof Ngaire Kerse

Address

Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland 1001

Country

New Zealand

Phone

+64 9 9234467

Fax

n.kerse@auckland.ac.nz

Contact person for public queries

Name

Ngaire Kerse

Address

Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland 1001

Country

New Zealand

Phone

+64 9 9234467

Fax

n.kerse@auckland.ac.nz

Contact person for scientific queries

Name

Ngaire Kerse

Address

Department of General Practice and Primary Health Care
School of Population Health, Tamaki Campus,
University of Auckland
Private Bag 92019, Auckland 1001

Country

New Zealand

Phone

+64 9 9234467

Fax

n.kerse@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1429	Clinical study report					377028-(Uploaded-21-02-2019-12-55-41)-Study-related document.pdf

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.

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