Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000290493
Ethics application status
Approved
Date submitted
19/05/2007
Date registered
1/06/2007
Date last updated
28/10/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a high intensity functional exercise program on physical performance in older adults at discharge from in-patient rehabilitation – A feasibility study
Scientific title
The effect of a high intensity functional exercise program on physical performance in older adults at discharge from in-patient rehabilitation – A feasibility study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mobility in older adults 1832 0
Condition category
Condition code
Physical Medicine / Rehabilitation 1924 1924 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to the intervention or control group. Participants in the control group will receciver usual in-patient rehabilitation therapy. The intervention group will receive usual in-patient rehabilitation physiotherapy plus participate in the HIFE exercise (progressive resistane and balance exercise) program 3x/wk for 45 minutes. The intervention period will run from the time of recruitment, until they are discharged from the inpatient rehabilition service. Please note that 'usual rehabilitation' involves daily physiotherapy treatment and exercises up to one hour per day performining activites to restore mobility and function post injury or trauma. The high intensity functional exercise (HIFE) program is a standardised program of lower-limb strength and balance exercises performed in functional weight bearing positions (sit to stand, step ups, lunges etc). The program is stratified into five categories from A (high level strength/balance) to E (unable to stand unsupported) . High intensity is achieved by performing strengthening exercises at a 10-12 repetition maximum, and balance exercises perform at the limits of postural stability individually prescribed to match a participants functional level.
Intervention code [1] 1771 0
Rehabilitation
Comparator / control treatment
Control group - 20 subjects: usual inpatient rehabilitation only up to 60mins 5 days per week (weekdays). Participants in the control group will not be participating in the HIFE exercise program.
Control group
Active

Outcomes
Primary outcome [1] 2737 0
Physical Performance Test score
Timepoint [1] 2737 0
On admission and discharge from inpatient rehabilitaion program
Secondary outcome [1] 4621 0
Timed up and go test time
Timepoint [1] 4621 0
On admission and discharge from inpatient rehabilitation program
Secondary outcome [2] 4622 0
10 m walk time and stride length
Timepoint [2] 4622 0
On admission and discharge from inpatient rehabilitation program
Secondary outcome [3] 4623 0
Grip strength on hand held dynamometer
Timepoint [3] 4623 0
On admission and discharge from inpatient rehabilitation program
Secondary outcome [4] 4624 0
6 minute walk test time
Timepoint [4] 4624 0
On admission and discharge from inpatient rehabilitation program
Secondary outcome [5] 4625 0
Reach distance
Timepoint [5] 4625 0
On admission and discharge from inpatient rehabilitation program
Secondary outcome [6] 4626 0
Falls efficacy scale score
Timepoint [6] 4626 0
On admission and discharge from inpatient rehabilitation program
Secondary outcome [7] 5965 0
Step Test
Timepoint [7] 5965 0
On admission and discharge from inpatient rehabilitation program

Eligibility
Key inclusion criteria
Participants will be an inpatient in a sub-acute rehabilitation ward. Participants will be aged 65 years or over, be medically stable, have current rehabilitation goals documented in their history and will be able to give informed consent.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from this study if they have significant cardiac or respiratory disease or any other medical illness that interferes with their ability to take part in a rehabilitation program, or requires palliative care. Patients that are non-weight bearing through their lower-limbs, or who have post-operative orders that contraindicate participation in the exercises included in the intervention program will also be excluded.

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)
Patients being admitted to 2 sub-acute rehabilitation wards will be screened for eligibility for this project by the ward physiotherapists, based on the inclusion/exclusion criteria. If a patient is interested, the ward physiotherapist will refer the patient to the lead investigator. At this time the lead investigator will formally assess the eligibility of the potential participant by checking if they meet the eligibility criteria and do not demonstrate any of the items listed as exclusion criteria. If the participant is eligible, they will be taken through the consent process by the study therapist. Once the participant has given informed consent, the participant will be randomised into the control or intervention group. The following procedure will be used:
1)Prior to the commencement of recruiting, and independent therapist not located on any wards associated with the study will generate a computerized random number sequence and hold this in secret.
2)The researchers will contact this therapist to say they have a participant recruited.
3)The pre-arranged independent therapist will then look at the randomized number sequence to inform the researchers if the next number on the table is an odd number or even number.
4)Subjects who are allocated an odd number will be placed in the control group; those allocated an even number will be placed in the intervention group.
5)This process will be repeated for each participant recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number sequence will be generate on a computer using the Excel program to generate a random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The physiotherapist assessing participant outcome measures pre- and post-intervention trial will be blinded to group allocation
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2069 0
Hospital
Name [1] 2069 0
Southern Health
Country [1] 2069 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
Monash Medical Centre
246 Clayton Rd
Clayton Vic 3168
Country
Australia
Secondary sponsor category [1] 1874 0
None
Name [1] 1874 0
Address [1] 1874 0
Country [1] 1874 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3843 0
Southern Health Human Research and Ethics Committee
Ethics committee address [1] 3843 0
Ethics committee country [1] 3843 0
Australia
Date submitted for ethics approval [1] 3843 0
Approval date [1] 3843 0
06/12/2007
Ethics approval number [1] 3843 0
07086B

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

Contacts
Principal investigator
Name 27874 0
Address 27874 0
Country 27874 0
Phone 27874 0
Fax 27874 0
Email 27874 0
Contact person for public queries
Name 10960 0
Melanie Farlie, Physiotherapist
Address 10960 0
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country 10960 0
Australia
Phone 10960 0
+61 3 92651000
Fax 10960 0
+61 3 92651574
Email 10960 0
[email protected]
Contact person for scientific queries
Name 1888 0
Melanie Farlie, Physiotherapist
Address 1888 0
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country 1888 0
Australia
Phone 1888 0
+61 3 92651000
Fax 1888 0
+61 3 92651574
Email 1888 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
No additional documents have been identified.