Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000580370
Ethics application status
Approved
Date submitted
6/10/2008
Date registered
19/11/2008
Date last updated
20/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the High Intensity Functional Exercise Group program improve clinical outcomes in older people in the sub-acute setting?
Scientific title
The short term effects of a High Intensity Functional Exercise (HIFE) group on mobility in older people in the sub-acute setting.
Secondary ID [1] 252247 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility in older adults 3795 0
Activity levels of older inpatients 295080 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3975 3975 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated into the intervention will be encouraged to attend the HIFE group three times a week as well as individual therapy aimed twice a week for the duration of their hospital admission. HIFE exercises will be prescribed by the treating therapist according to a previously described, standardised protocol (Littbrand 2006) which includes weight bearing functional exercises for strength and balance targeted at different levels of mobility. The HIFE group sessions will be aimed at least 20 minutes duration. Participants will be encouraged to perform at least 2 balance and 2 strength exercises at a high intensity and the treating therapist will increase the difficulty as appropriate. To maintain a high intensity, strength exercises will be aimed at 8-12 repetition maximum (RM) performed as 2-3 sets, and balance exercises to challenge the participant’s postural stability. To ensure safety of all group participants, the maximum number of participants in the HIFE group will be limited to 6. All exercises will be performed at a set of rails in the ward gymnasium with one physiotherapist or allied health assistant taking the group. An additional physiotherapist may also assist in the running of the group if the therapist feels another person to assist is indicated e.g. any of the participants require more than the assistance of one person to stand from a chair. Individual therapy sessions may range from 5 minutes to one hour, as deemed appropriate by the treating physiotherapist. The type of exercises in the individual therapy sessions will be determined by the treating therapist as appropriate - these may include strengthening, balance, cardiovascular and range exercises.
The duration of the trial is anticipated to 3+ years.
Those who are allocated to the intervention will also be invited to participate in an interview about their experiences of the group physiotherapy. If consent is obtained for this interview and for it to be audiorecorded, it will take place after participants have taken part in several group sessions. It is anticipated that the interview will take approximately 20 minutes. We aim to continue to invite participants to be interviewed until no new themes emerge from interviews.
Intervention code [1] 3515 0
Rehabilitation
Comparator / control treatment
Control Treatment: 'usual care' inpatient individual physiotherapy sessions, aimed at 5 times per week until discharged from hospital. They will not participate in the HIFE group program. Therapy session length will be determined by the treating therapist, influenced by the ability of each patient. It may vary between 5 minutes and 60 minutes and therapy is determined by the treating therapist.
Control group
Active

Outcomes
Primary outcome [1] 4876 0
Elderly Mobility Scale
Timepoint [1] 4876 0
At baseline (admission to the study) and on discharge if discharge is to their premorbid residence. If the patient is to be discharged into residential care then the final measurement will be taken when the multidisciplinary team have determined the patient has reached a plateau.
Primary outcome [2] 4877 0
Berg Balance Scale
Timepoint [2] 4877 0
At baseline (admission to the study) and discharge if discharge is to their premorbid residence. If the patient is to be discharged into residential care then the final measurement will be taken when the multidisciplinary team have determined the patient has reached a plateau.
Primary outcome [3] 4878 0
Falls Rate
Timepoint [3] 4878 0
Daily during hospital admission and totalled upon discharge
Secondary outcome [1] 8232 0
Length of Stay (days)
Timepoint [1] 8232 0
On discharge
Secondary outcome [2] 8233 0
Discharge Destination
Timepoint [2] 8233 0
On discharge
Secondary outcome [3] 8234 0
Weight (kg)
Timepoint [3] 8234 0
At baseline (admission to the study) and discharge if discharge is to their premorbid residence. If the patient is to be discharged into residential care then the final measurement will be taken when the multidisciplinary team have determined the patient has reached a plateau.
Secondary outcome [4] 8235 0
Mini-Mental State Examination
Timepoint [4] 8235 0
On admission
Secondary outcome [5] 314712 0
perspectives of those participating in group exercise on group exercise. A single, semi structured interview will be conducted with a number of participants with a researcher. The interview will be guided by a number of open ended questions and interviews audiorecorded and transcribed verbatim 24 hours after each interview.
Timepoint [5] 314712 0
after participating in at least 2-3 group exercise sessions.
Secondary outcome [6] 314713 0
Activity levels - time spent upright, sitting, lying down, walking, overall activity levels.
Participants will wear a Positional Activity Logger 2 (PAL2) accelerometer over a 5 day period, comprising 3 week days and 2 week end days. This is attached to their leg and worn 24 hours per day (excluding for showering/hygiene purposes)
Timepoint [6] 314713 0
5 days during admission: 3 weekdays and 2 weekend days. This will occur during their admission, after they have participated in at least one exercise group (if in intervention) or anytime if in the control arm. It will be at least 5 days prior to their expected date of discharge.

Eligibility
Key inclusion criteria
Aged 65 and older
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with contraindications to exercise
Premorbidly non-ambulant > 1 month
Palliative Care
Known Length of stay < 7 days
Mini-Mental State Examination <10
Those who require more than minimal assistance of one person to stand from a standard chair with arm rests.

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)
Once deemed eligible for the study, an independent clinician who is not in a dependent/therapeutic relationship with the patient will seek informed consent – those with Mini-Mental State Examination (MMSE) 24/30 or less will have their next of kin contacted for third party acknowledgement. Patients declining to participate will receive usual assessment and physiotherapy as appropriate. Those who consent will have their baseline measures assessed and recorded for the study by their treating therapist. Patients will then be randomised to one of two physiotherapy treatments by a non-treating therapist who is independent of the study team. The randomisation will occur by opening a sequentially numbered opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by use of a computer generated sequence to create a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Baseline measures will be asessed by the treating physiotherapist prior to randomisation. Outcome measures on discharge will be assessed by a blinded assessor.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2008
Actual
21/10/2008
Date of last participant enrolment
Anticipated
Actual
2/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
468
Accrual to date
Final
468
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3980 0
Hospital
Name [1] 3980 0
Caulfield General Medical Centre
Country [1] 3980 0
Australia
Primary sponsor type
Hospital
Name
Caulfield General Medical Centre
Address
260 Kooyong Road
Caulfield
Victoria 3162
Country
Australia
Secondary sponsor category [1] 3569 0
None
Name [1] 3569 0
Address [1] 3569 0
Country [1] 3569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6054 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 6054 0
Ethics committee country [1] 6054 0
Australia
Date submitted for ethics approval [1] 6054 0
Approval date [1] 6054 0
20/08/2008
Ethics approval number [1] 6054 0
190/08
Ethics committee name [2] 295074 0
La Trobe Faculty of Health Sciences Ethics Committee
Ethics committee address [2] 295074 0
Ethics committee country [2] 295074 0
Australia
Date submitted for ethics approval [2] 295074 0
21/01/2009
Approval date [2] 295074 0
10/03/2009
Ethics approval number [2] 295074 0
FHEC 09/11

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

Contacts
Principal investigator
Name 29009 0
Ms Melissa Raymond
Address 29009 0
Physiotherapy Dept, Caulfield Hospital
260 Kooyong Road Caulfield Vic 3162
Country 29009 0
Australia
Phone 29009 0
+61390766000
Fax 29009 0
Email 29009 0
[email protected]
Contact person for public queries
Name 12166 0
Melissa Raymond
Address 12166 0
Caulfield General Medical Centre
260 Kooyong Road
Caulfield
Victoria 3162
Country 12166 0
Australia
Phone 12166 0
+61 3 9076 6000
Fax 12166 0
Email 12166 0
[email protected]
Contact person for scientific queries
Name 3094 0
Melissa Raymond
Address 3094 0
Caulfield General Medical Centre
260 Kooyong Road
Caulfield
Victoria 3162
Country 3094 0
Australia
Phone 3094 0
+61 3 9076 6000
Fax 3094 0
Email 3094 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
SourceTitleYear of PublicationDOI
EmbaseExperiences of older adults in a group physiotherapy program at a rehabilitation hospital: A qualitative study.2016https://dx.doi.org/10.1002/jhm.2550
EmbaseThe effects of a high-intensity functional exercise group on clinical outcomes in hospitalised older adults: An assessor-blinded, randomisedcontrolled trial.2017https://dx.doi.org/10.1093/ageing/afw215
N.B. These documents automatically identified may not have been verified by the study sponsor.