Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001316695
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of strengthening or balance exercises in a Falls & Balance Program
Scientific title
Efficacy of strengthening or balance exercises in a Falls & Balance Program for older adults aged 65 and over with a falls history
Secondary ID [1] 310626 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 331504 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328239 328239 0 0
Physiotherapy
Injuries and Accidents 328339 328339 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Allocation
Participants will be allocated to either the strengthening group or balance group using block allocation method. The first 2 months (8 weeks) of recruitment period, patients will be allocated to the strengthening group and the subsequent 2 months (8 weeks), patients will be allocated to the balance group. The allocation method will continue until the sample size is reached.

Strengthening Group
Participants who are allocated to the strengthening group will receive one hour of lower limbs strengthening exercises and 30 minutes of occupational therapy session twice a week for 6 weeks in a group setting up to 6 participants. Participants will receive a home exercise program on discharge.

Balance Group
Participants who are allocated to the balance group will receive one hour of balance exercises and 30 minutes of the same occupational therapy session as the strengthening group twice a week for 6 weeks in a group setting up to 6 participants. Participants will receive the same home exercise program on discharge.

Treatment Intervention

Exercises
Participants will complete sixty minutes of exercise in each session. The exercises have been prescribed based off the Otago Exercise Program (OEP). This program consists of 23 strength and balance exercises. All participants will complete the same warm up exercises for both Strengthening and Balance group. Then the main exercises will be allocated to the respective groups which include targeting the strength of knee extensors, knee flexors, hip adductors, ankle plantarflexors and the balance exercises including knee bends, walking backwards, walking and turning around, walking sideways, tandem stance, tandem walk and one leg stance. The groups will begin by being prescribed 10 repetitions as per the OEP and progressed by increasing repetitions and/or weights. The intensity of the exercises will be at low intensity between the Rate Perceived Exertion scale 3 and 5. Participants will be given a standard home exercise program on completion of the program. Participants may experience some discomfort after exercising such as delayed onset muscle soreness which is no difference to any exercise intervention. Therapists will monitor participants’ comfort in each session and will modify the dosage of the exercises if required.

On completion of the program, participants will receive a home exercise program that they can continue at home. The home exercise program consists of the same exercises that they participated during program.

Occupational Therapy
Participants in each group will receive the same thirty minutes of occupational education session delivered by an occupational therapist. Education including pacing strategies, falls prevention strategies and relaxation techniques.
Intervention code [1] 327027 0
Rehabilitation
Comparator / control treatment
The comparator group will be the balance group.

Outcome measures will be assessed between the strengthening group and the balance group
Control group
Active

Outcomes
Primary outcome [1] 336109 0
Time Up & Go Test
Timepoint [1] 336109 0
Initial Assessment (pre-commencement of the program), Discharge (upon completion of the program), 1 month and 3 month follow-up post-completion of the program
Secondary outcome [1] 426858 0
Knee Extensor Strength
Timepoint [1] 426858 0
Initial Assessment (pre-commencement of the program), Discharge (upon completion of the program), 1 month and 3 month follow-up post-completion of the program
Secondary outcome [2] 426860 0
Health-related Quality of Life
Timepoint [2] 426860 0
Initial Assessment (pre-commencement of the program), Discharge (upon completion of the program), 1 month and 3 month follow-up post-completion of the program
Secondary outcome [3] 426861 0
Walking distance
Timepoint [3] 426861 0
Initial Assessment (pre-commencement of the program), Discharge (upon completion of the program), 1 month and 3 month follow-up post-completion of the program
Secondary outcome [4] 426862 0
Risk of falling
Timepoint [4] 426862 0
Initial Assessment (pre-commencement of the program), Discharge (upon completion of the program), 1 month and 3 month follow-up post-completion of the program
Secondary outcome [5] 426863 0
Balance dysfunction
Timepoint [5] 426863 0
Initial Assessment (pre-commencement of the program), Discharge (upon completion of the program), 1 month and 3 month follow-up post-completion of the program

Eligibility
Key inclusion criteria
Patients are eligible for inclusion in the study if they:
i. Referred to Falls & Balance program at SJG Berwick Hospital
ii. age 65 and over
iii. Had a least one mechanical fall in the last 12 months prior to the commencement of the program
iv. Able to read and speak in English
v. Able to provide written consent
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are excluded if they:
i. Have Parkinson disease
ii. Had stroke in the last six months
iii. Have multiple sclerosis
iv. Had recent spinal surgery in the last six months
v. Have peripheral neuropathy
vi. Unable to participate one hour of exercise during the study period
vii. Have missed more than two consecutive sessions in the program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
29/07/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314843 0
Hospital
Name [1] 314843 0
St John of God Berwick Hospital
Country [1] 314843 0
Australia
Primary sponsor type
Hospital
Name
St John of God Berwick Hospital
Address
75 Kangan Drive, Berwick, Victoria 3806
Country
Australia
Secondary sponsor category [1] 316830 0
None
Name [1] 316830 0
Address [1] 316830 0
Country [1] 316830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313843 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 313843 0
Ethics committee country [1] 313843 0
Australia
Date submitted for ethics approval [1] 313843 0
01/05/2023
Approval date [1] 313843 0
16/05/2023
Ethics approval number [1] 313843 0

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

Contacts
Principal investigator
Name 129526 0
Ms Angel Ching
Address 129526 0
St John of God Berwick Hospital, 75 Kangan Drive, Berwick, VIC 3806
Country 129526 0
Australia
Phone 129526 0
+61 387845484
Fax 129526 0
Email 129526 0
[email protected]
Contact person for public queries
Name 129527 0
Angel Ching
Address 129527 0
St John of God Berwick Hospital, 75 Kangan Drive, Berwick, VIC 3806
Country 129527 0
Australia
Phone 129527 0
+61 387845484
Fax 129527 0
Email 129527 0
[email protected]
Contact person for scientific queries
Name 129528 0
Angel Ching
Address 129528 0
St John of God Berwick Hospital, 75 Kangan Drive, Berwick, VIC 3806
Country 129528 0
Australia
Phone 129528 0
+61 387845484
Fax 129528 0
Email 129528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
data underling published results only
When will data be available (start and end dates)?
available for 5 years after publication
Available to whom?
sharing to other researchers for the purposes of IPD meta-analysis
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator - Angel Ching, email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20390Informed consent form    386617-(Uploaded-18-09-2023-11-12-13)-Study-related document.pdf
20391Ethical approval    386617-(Uploaded-18-09-2023-11-12-32)-Study-related document.pdf
20392Study protocol    386617-(Uploaded-18-09-2023-11-13-15)-Study-related document.pdf



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.