Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000057381
Ethics application status
Approved
Date submitted
4/01/2017
Date registered
11/01/2017
Date last updated
11/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Up, Move and Thrive: efficacy and feasibility of an exercise program for improving activity levels and quality of life for aged care residents.
Scientific title
Increasing activity levels and quality of life for those in an aged care environment through exercise - effectiveness and feasibility.
Secondary ID [1] 290828 0
None
Universal Trial Number (UTN)
U1111-1191-2986
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aged Care 301499 0
Activity Levels 301500 0
Quality of Life 301501 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301212 301212 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to pilot an exercise physiology service to older people in Independent Living and Residential Care facilities managed by MercyCare (Wembley, Western Australia), with the objective of enabling residents to improve their health and wellbeing, and facilitate enhanced independence. This will be achieved by employing an Accredited Exercise Physiologist to provide a specifically tailored exercise program to the residents. For those in Independent Living the program would aim to increase their ability to participate in they daily activities, and potentially increase their capacity to remain independent. For those in the residential care facility, the aim is to increase the level of physical activity and engagement in functional tasks. This study will use a mixed-methods research design to ensure quality findings to guide future decision making and the translation of research into practice. The study will have two data collection phases - baseline and post-intervention, and a 12 week intervention where participants will participate in an Accredited Exercise Physiologist-led therapy program including individual and group sessions. The participants will be residents from the Independent Living and Residential Care facilities of MercyCare Wembley. Staff in the Residential Care facility including nurses, carers, allied health staff and management will be recruited for focus groups, and family members will be recruited for semi-structured interviews at baseline and post-intervention.

The level of activity of participants will be assessed both pre- and post-intervention, using the International Physical Activity Questionnaire (IPAQ, 2005) for independent living (IL) participants, and a behavioural/observational mapping approach for the residential care (RC) participants. The self-administered IPAQ will take approximately 5-10 minutes for each participant to fill out. It covers four domains of physical activity: work-related, transportation, housework/gardening and leisure-time activity. In each domain the number of days per week and time per day spent in both moderate and vigorous activity are recorded. The questionnaire also includes questions about time spent sitting as an indicator of sedentary behaviour and time walking. The observational behavioural mapping will be modelled on a protocol used by Bernhardt and colleagues (2004) to examine the mobility patterns of patients in an acute stroke ward. It will be conducted over two consecutive days from 9am to 6pm (considered the most active period of the resident's day). The resident will be observed every ten minutes except for four randomly scheduled 10-minute breaks. At each time point the observer will record the activity, the resident's location and any person attending the resident. Observations will take approximately 1 minute per resident with the highest level of activity being recorded during this period. The order of resident observations will remain the same for the two days. Observations will be made on two separate occasions each one week apart. At each observation, 11 physical activities will be recorded as used by Bernhardt et al. (2004) which are similar to those used previously in rehabilitations studies by Esmonde et al. (1997) and Mackey et al. (1996). The 11 physical activities include talking/reading/watching TV, eating, transfer, standing activities, sitting (supported in bed, supported out of bed, no support) and will be classified on five levels of activity from no activity to high therapeutic activity. The people present will include family, nursing and other staff, with the locations including bedroom, bathroom, and dining room. Residents from the Independent Living village will have the following anthropometric and physical measurements taken at baseline and post-intervention: age, gender, relevant medical history, smoking status, waist circumference, weight, 6-minute walk test, 30 second sit to stand test, and timed unipedal stance test (details provided in data collection form). The participants from the residential care aged care facilities will have the following measurements taken at baseline and post-intervention: age, gender, relevant medical history, smoking status, height, weight, % body fat, time 'up and go', sit to stand and one step, 2-minute walk test, knee muscle strength, hand grip strength test, sitting object lift task, and balance standing.

INTERVENTION - The intervention groups will perform AEP-supervised exercise sessions – 1 hour x 3 days/week for 12 weeks. The program will be prescribed according to individual needs, location (IL or RC), and will involve task-specific goal-setting and a related components approach intervention. The task-specific goals for those in RC will be informed by the activity analysis that is routinely completed by the physiotherapist and nurse to determine the resident's mobility, falls risk and dexterity (Standard 2 Health and Personal Care; Outcome 2.14). The intervention will also be informed by observations and data gathered by the AEP during baseline assessments. The observations and data collected for those participants from the independent living village (IL) will be; age, gender, relevant medical history, smoking status, waist circumference (by placing a tape measure directly on to skin or over no more than one layer of light clothing), and weight. Physical activity will also be assessed using the 6 minute walk test (assesses distance walked over 6 minutes), the 30 second sit to stand test (a measurement to assess functional lower extremity strength in older adults) and timed unipedal stance test (single leg support, one leg stance test to measure risk of falls). Individual goals will be communicated by the AEP to all staff associated with the care of each resident, together with strategies to facilitate the resident's engagement in specific task(s). Therapy fidelity will be assessed by the investigators through video analysis of 10% of sessions. Control groups will continue with usual activity or usual care during the 12 week intervention. For the participants from residential care the exercise sessions will be conducted on an individual basis and will most likely take place in the resident's room. Some may also take place in a separate area within the facility if there is not enough space in the individual's room. For the residents in the IL facility the sessions may be individual or in small groups of similar participants. These sessions will take place in a communal convenient area at the facility. For all participants, the exercises performed will be prescribed according to the individual's level of activity/mobility. The program will be composed of strength, balance. flexibility and aerobic exercises as per the best available evidence and guidelines for older adults living in long=term care facilities. The exercises will be low to moderate intensity.
Intervention code [1] 296749 0
Treatment: Other
Intervention code [2] 296777 0
Rehabilitation
Comparator / control treatment
During the 12 week intervention phase the control group will go about their normal everyday activities and will not attend any sessions run by the exercise physiologist.
Control group
Active

Outcomes
Primary outcome [1] 300624 0
Level of Activity - measured using International Physical Activity Questionnaire for Independent Living participants, and Observational Behavioural Mapping for Residential Care participants.
Timepoint [1] 300624 0
Level of activity will be assessed at baseline and post-intervention.
Secondary outcome [1] 330435 0
% time spent with others (e.g., family, staff) and in various locations for those in residential care as measured by observational behavioural mapping.
Timepoint [1] 330435 0
Baseline and post-intervention.
Secondary outcome [2] 330481 0
Quality of Life - measured using the 4-dimension version of 'The Assessment of Quality of Life" (Hawthorne et al., 1999)
Timepoint [2] 330481 0
Baseline and post-intervention.
Secondary outcome [3] 330482 0
Perception of physical and psycho-social benefits to taking part in the study - semi-structured interviews of participants, focus group of staff members and individual interviews of family members.
Timepoint [3] 330482 0
Post-intervention.

Eligibility
Key inclusion criteria
- able to give informed consent
- resident of MercyCare Retirement Village or Mercy Residential Care in Wembley
- English speaking
- judged by physiotherapist at MercyCare to be clinically stable to participate.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- non-English speaking
- serious medical condition that would put participant in danger (e.g. recent heart attack) as judged by physiotherapist at MercyCare
- cognitive impairment that would impair performance or prevent the participant from understanding the instructions.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2017
Actual
Date of last participant enrolment
Anticipated
30/04/2017
Actual
Date of last data collection
Anticipated
31/07/2017
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 14977 0
6014 - Wembley

Funding & Sponsors
Funding source category [1] 295268 0
University
Name [1] 295268 0
Edith Cowan University
Country [1] 295268 0
Australia
Funding source category [2] 295269 0
Other
Name [2] 295269 0
MercyCare
Country [2] 295269 0
Australia
Funding source category [3] 295270 0
Commercial sector/Industry
Name [3] 295270 0
Arche Health Limited
Country [3] 295270 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Annette Raynor
Address
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 294094 0
Individual
Name [1] 294094 0
Ms Beverley Wheeler
Address [1] 294094 0
Executive Director Aged Care Services
MercyCare
38 Ord Street
West Perth WA 6005
Country [1] 294094 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296603 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 296603 0
Ethics committee country [1] 296603 0
Australia
Date submitted for ethics approval [1] 296603 0
22/11/2016
Approval date [1] 296603 0
23/12/2016
Ethics approval number [1] 296603 0
15808

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71406 0
A/Prof Annette Raynor
Address 71406 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
Perth WA 6027
Country 71406 0
Australia
Phone 71406 0
+61863042771
Fax 71406 0
+61863045990
Email 71406 0
[email protected]
Contact person for public queries
Name 71407 0
Jane White
Address 71407 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
Perth WA 6027
Country 71407 0
Australia
Phone 71407 0
+61415918230
Fax 71407 0
Email 71407 0
[email protected]
Contact person for scientific queries
Name 71408 0
Annette Raynor
Address 71408 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
Perth WA 6027
Country 71408 0
Australia
Phone 71408 0
+61863042771
Fax 71408 0
Email 71408 0
[email protected]

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
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