ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000034932

Ethics application status

Approved

Date submitted

10/01/2011

Date registered

11/01/2011

Date last updated

18/01/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Promoting activity for frail aged in post-acute hospital settings: a randomised controlled trial of accelerometry

Scientific title

In frail aged rehabilitation inpatients is provision of activity data from accelerometry monitoring to assist goal setting more effective than usual rehabilitation care in increasing activity levels?

Secondary ID [1]

APP: 1007886 National Health and Medical Research Council

Universal Trial Number (UTN)

UTN 1111-1118-9227

Trial acronym

Linked study record

Health condition

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

Musculoskeletal De-conditioning

Mobility decline

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will wear an accelerometer from the time of waking in the morning until going to bed in the evening ie during waking hours. The accelerometer will be removed for showering. At commencement, the treating physiotherapist will discuss with the patient their mobility goals, including provisional targets for daily walking time. These goals will be re-examined and modified, informed by the accelerometer data, to motivate the patient to improve activity levels and reach set targets. The targets will be reviewed weekly until discharge or 4 weeks, whichever is sooner. Feedback of the previous day’s walking time will be given to the patient and treating therapist and will be recorded in the patient’s records. Walking times over a week will be summarised in chart form and made available at the weekly case conference. All staff will be trained in the use of accelerometry data and be asked to encourage patients to meet their activity goals.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

Usual rehabilitation care including the setting of mobility goals. Neither staff nor patients will receive data on monitored walking times to aid in the setting of walking time targets.

Control group

Active

Outcomes

Primary outcome [1]

Daily walking times as assessed by accelerometry

Timepoint [1]

Repeated daily measures during the study period

Secondary outcome [1]

Lower extremity function as measured by the Short Physical Performance Battery

Timepoint [1]

At study entry and exit

Secondary outcome [2]

Functional status as assessed using the interRAI Post-Acute Care instrument

Timepoint [2]

At study entry and exit and 28 day phone follow-up post discharge

Secondary outcome [3]

Exercise self-efficacy as measured by the Short Self-Efficacy and Outcome Expectation for Exercise Scales

Timepoint [3]

At study entry and exit

Secondary outcome [4]

Health-related quality of life as measured by EQ-5D

Timepoint [4]

At study entry and exit and 28 day phone follow-up post discharge

Secondary outcome [5]

Length of stay recorded on hospital discharge records

Timepoint [5]

At discharge from rehabilitation

Eligibility

Key inclusion criteria

Patients admitted to post-acute care rehabilitation who are (1) aged greater than or equal to 60 years; (2) able to ambulate independently or with supervision, or who have a rehabilitation goal to become ambulant within the context of the current admission; and (3) expected to have a length of stay of at least 2 weeks will be eligible to participate.

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will be those (1) with lower limb amputation; (2) with delirium/agitated dementia; or (3) not expected to walk within 4 weeks of admission.

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)

At each site, within 3 days of admission to post acute care rehabilitation, eligible patients will be identified by a staff member from the rehabilitation team and the names will be given to the research member, who will obtain informed consent for participation. At point of entry into the study, and prior to random allocation to either the intervention or control group, consenting participants will be stratified by mobility status - either walking independently (with or without walking aids) or walking with supervision. A random number sequence will be generated for the order of group allocation within the two strata. Random group allocation will be centrally managed by a member of the research staff who is not involved in assessment of measures or intervention delivery.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A random number sequence will be generated using computerised sequence generation for group allocation within the two strata. Random group allocation will be centrally managed by a member of the research staff who is not involved in assessment of measures or intervention delivery.

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

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2011

Actual

31/10/2011

Date of last participant enrolment

Anticipated

Actual

12/09/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

270

Accrual to date

Final

270

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [2]

Hornsby Ku-ring-gai Hospital - Hornsby

Recruitment hospital [3]

Repatriation Hospital - Daw Park

Recruitment postcode(s) [1]

4102

Recruitment postcode(s) [2]

2077

Recruitment postcode(s) [3]

5041

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Research and Innovation Division, The University of Queensland, St Lucia, QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2011

Approval date [1]

11/03/2011

Ethics approval number [1]

HREC/11/QPAH/043

Ethics committee name [2]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [2]

Level 2 Building 31, Royal North Shore Hospital, St Leonards, NSW 2065

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

03/02/2011

Approval date [2]

03/03/2011

Ethics approval number [2]

HREC/11/HAWKE/14

Ethics committee name [3]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [3]

Flinders Medical Centre, Bedford Park, SA 5042, Australia

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

14/01/2011

Approval date [3]

23/03/2011

Ethics approval number [3]

SAC HREC 012.11

Summary

Brief summary

BACKGROUND
A goal in rehabilitation for older people is promotion of mobility to reverse functional decline and deconditioning. Recent developments in accelerometry for quantifying ambulatory activity can assist clinical practice in rehabilitation settings.

AIM
The study tests the hypothesis that use of accelerometry to provide accurate activity data to patients and clinicians, in the context of explicit goal setting, substantially increases patient walking activity. The study will also explore the effects of increased activity on patient outcomes and undertake a cost utility analysis.

RESEARCH PLAN
A randomised controlled trial will be conducted in Geriatric Rehabilitation Units at 3 sites (QLD, NSW, SA). Eligible patients are aged greater than or equal to 60 and able to ambulate. Based on pilot data, a sample size of 270 patients (135 per group) is required to demonstrate a mean significant differencein daily walking time of 33% between intervention and control groups.Accelerometers will be fitted to eligible subjects to monitor daily activity. Intervention subjects will be offered a formal activity-related rehabilitation goal, and receive daily feedback, sourced from the accelerometer, of their activity levels. Neither staff nor subjects in the control arm of the trial will receive data on walking times. The primary outcome measure will be walking times measured by accelerometry. Secondary outcome measures will include lower extremity function, quality of life, length of stay, post discharge hospital readmissions and level of care at one month follow-up. The time frame for the study is two years six months.

SIGNIFICANCE
If patient activity can be increased through the use of accelerometer data, it will revolutionise the management of activity in hospital. There will be enormous impetus to further develop accelerometer technology for clinical application so that activity prescription will be a routine component of a rehabilitation care plan.

Trial website

Trial related presentations / publications

Dakin LE, Gray LC, Peel NM, Salih SA, Cheung VH. Promoting walking amongst older patients in rehabilitation: are accelerometers the answer? J Nutr Health Aging 2010;14(10):863-5.

Public notes

Contacts

Principal investigator

Name

Prof Leonard Gray

Address

Centre for Research in Geriatric Medicine
The University of Queensland School of Medicine
Level 2 Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102

Country

Australia

Phone

+61 7 3176 5530

Fax

len.gray@uq.edu.au

Contact person for public queries

Name

Dr Nancye Peel

Address

Centre for Research in Geriatric Medicine, The University of Queensland School of Medicine, Level 2, Building 33, Princess Alexandra Hospital, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 7 3176 7402

Fax

+61 7 3176 6945

n.peel@uq.edu.au

Contact person for scientific queries

Name

Professor Len Gray

Address

Centre for Research in Geriatric Medicine, The University of Queensland School of Medicine, Level 2, Building 33, Princess Alexandra Hospital, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 7 3176 5530

Fax

+61 7 3176 6945

len.gray@uq.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

Source	Title	Year of Publication	DOI
Embase	Promoting activity in geriatric rehabilitation: A randomized controlled trial of accelerometry.	2016	https://dx.doi.org/10.1371/journal.pone.0160906

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically