Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000046202
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
16/01/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise provided in group setting on top of usual physiotherapy be feasible and improve balance and functional outcome in Geriatric Evaluation and Management unit patients?
Scientific title
Does exercise provided via circuit training in addition to usual physiotherapy be feasible and improve balance and functional outcome in Geriatric Evaluation and Management unit patients?
Secondary ID [1] 293449 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GUCCI (Gem Unit Circuit Class Intervention)- program
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Geriatrics 305627 0
Falls 305789 0
Reduced mobility 305790 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304848 304848 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be participating in a
1. Circuit based exercise group class which consist of standing work station such as sit to stand, standing reaching task, stepping practice, walking & calf raise. Each exercise station will be for 5 minutes and participants will be encouraged to complete each station.
Participants will be attending the circuit group until they are discharge from GEM unit.
2. Participants will attend 3 times per week for 45 minutes in adjunct to there usual physiotherapy
3. Participants will be assessed there outcome at the admission and discharge from the unit
4. Physiotherapist and physiotherapist assistance will be administering the intervention
5. A patient exercise sheet will include there attendance, no of repetition of each exercises.
Intervention code [1] 299691 0
Rehabilitation
Comparator / control treatment
Control group will participate in usual physiotherapy which is 1 hour per day until discharged from GEM unit and consist of one to one face to face therapy with physiotherapist consisting of functional exercises such as sit to stand, walking, balance exercises etc
Control group
Active

Outcomes
Primary outcome [1] 304050 0
Composite balance measures: It comprises of 5 standing balance test
- Feet apart
- Feet together
- Semi-tandem
- Tandem
- Single leg stance
Each test will be performed without aid or upper limb support and timed up to maximum of 10 sec each.
The timed each positioned has been maintained will be summed to give a total for which the maximal score will be 50 sec

The total of all the above will be added to out of 50
Timepoint [1] 304050 0
Before joining the intervention group and at discharge
Primary outcome [2] 304174 0
Short Physical Performance Scale:
Timepoint [2] 304174 0
Before joining the intervention group and at discharge
Secondary outcome [1] 340789 0
Balance outcome measure for elderly rehabilitation (BOOMER)
Timepoint [1] 340789 0
Before joining the intervention group and at discharge
Secondary outcome [2] 341135 0
Functional Independence measure
Timepoint [2] 341135 0
From medical records at the time of admission to GEM unit and at discharge from unit
Secondary outcome [3] 341136 0
Length of hospital stay as assessed by review of medical records
Timepoint [3] 341136 0
Length of stay in hospital will be recorded from medical record at the time of discharge from GEM unit
Secondary outcome [4] 341137 0
No of falls will be reviewed from medical records. It will comprise of fall while attending the circuit group and falls during there stay in GEM unit.
Timepoint [4] 341137 0
It will collected from review of medical records at the end of participants stay in GEM unit
Secondary outcome [5] 341138 0
Information about Hospital Re-admission after 1 month will be collected from medical chart and phone call to participants after 1 month of there discharge from GEM unit
Timepoint [5] 341138 0
Medical chart will be reviewed and phone call made to individual participants after 1 month of there discharge from GEM unit

Eligibility
Key inclusion criteria
Patients who are admitted to Geriatric assessment and Management Unit in Royal Brisbane & Women's Hospital and
- Are 65 years and above
- can stand 30 sec with out any assistance of hand and equipment
- 17 and more Mini mental scale exam
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unstable, pre-morbid non- ambulant, admitted to palliation, weight- bearing restriction, inappropriate behaviour or cognition for group therapy.

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)
concealed allocation using sealed opaque envelop
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Between group analyses, either independent t-test or non- parametric Kruskal-Wallis test will be used to compare the composite balance score, BOOMER, FIM, and LOS, between groups over time. Hospital readmission and number of falls will be compared between group by a chi square crosstabs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2018
Actual
1/05/2018
Date of last participant enrolment
Anticipated
31/10/2018
Actual
4/01/2019
Date of last data collection
Anticipated
30/11/2018
Actual
22/02/2019
Sample size
Target
96
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9441 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 18155 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 298075 0
Charities/Societies/Foundations
Name [1] 298075 0
Royal Brisbane & Women's Hospital Foundation
Country [1] 298075 0
Australia
Primary sponsor type
Individual
Name
Rajesh paratap Singh
Address
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane & Women's hospital.
Bowen Bridge Rd & Butterfield St,
Herston QLD
Australia- 4029
Country
Australia
Secondary sponsor category [1] 297152 0
None
Name [1] 297152 0
Address [1] 297152 0
Country [1] 297152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299096 0
Royal Brisbane and Women's Hospital HREC (EC00172)
Ethics committee address [1] 299096 0
Ethics committee country [1] 299096 0
Australia
Date submitted for ethics approval [1] 299096 0
28/11/2017
Approval date [1] 299096 0
06/03/2018
Ethics approval number [1] 299096 0
HREC/17/QRBW/683

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2211 2211 0 0
/AnzctrAttachments/374054-Singh_RajeshPratap_2018ProjectGrant_RBWHand RBWHFoundation research project grants application form.pdf (Other)
Attachments [2] 2212 2212 0 0
/AnzctrAttachments/374054-PROJECT DESCRIPTION.docx (Protocol)

Contacts
Principal investigator
Name 79274 0
Mr Rajesh Pratap Singh
Address 79274 0
Physiotherapy Department
Level 2 Ned Henlon Building
Royal Brisbane and Women’s Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country 79274 0
Australia
Phone 79274 0
+61 413428047
Fax 79274 0
Email 79274 0
[email protected]
Contact person for public queries
Name 79275 0
Rajesh Pratap Singh
Address 79275 0
Physiotherapy Department
Level 2 Ned Henlon Building
Royal Brisbane and Women’s Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country 79275 0
Australia
Phone 79275 0
+61 413428047
Fax 79275 0
Email 79275 0
[email protected]
Contact person for scientific queries
Name 79276 0
Rajesh Pratap Singh
Address 79276 0
Physiotherapy Department
Level 2 Ned Henlon Building
Royal Brisbane and Women’s Hospital
Cnr Butterfield St and Bowen Bridge Rd
HERSTON QLD 4029
Country 79276 0
Australia
Phone 79276 0
+61 413428047
Fax 79276 0
Email 79276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Have not decided yet


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.