Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001190695
Ethics application status
Approved
Date submitted
6/10/2023
Date registered
17/11/2023
Date last updated
17/11/2023
Date data sharing statement initially provided
17/11/2023
Date results information initially provided
17/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are participants of balance programs achieving and maintaining a reduction in falls risk?
Scientific title
An evaluation of immediate and lasting effects of land-based and water-based clinical falls-prevention programs on physical outcomes associated with falls risk in community-dwelling adults referred to balance group programs.
Secondary ID [1] 310734 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 331678 0
Neurological Condition 331679 0
Aging 331680 0
Condition category
Condition code
Neurological 328407 328407 0 0
Parkinson's disease
Neurological 328408 328408 0 0
Dementias
Neurological 328409 328409 0 0
Multiple sclerosis
Neurological 328410 328410 0 0
Other neurological disorders
Stroke 328411 328411 0 0
Haemorrhagic
Stroke 328412 328412 0 0
Ischaemic
Physical Medicine / Rehabilitation 328413 328413 0 0
Physiotherapy
Physical Medicine / Rehabilitation 328414 328414 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 328415 328415 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Land-based exercise-based falls prevention program (Low Level). Located in a hospital outpatient facility gymnasium. Ten week (2xweekly), 45-50 min face-to-face exercise sessions facilitated by an accredited exercise physiologist and allied health assistant. Program utilises equipment such as chairs, rails, dura disc, foam, rocker-boards, balls, cones, walking obstacles and steppers. Six participants at a time commencing on a rolling start (ie. participants start when a spot opens and finish after ten weeks). Sessions consist of 5 - 10mins warm-up which includes exercises like walking in the rails in various directions, sit-to-stands/squats and marching on the spot, This is followed by a 35 min circuit of balance tasks such as standing on various unstable surfaces (foam, dura disc, rocker-boards etc), narrowing base of support while multitasking (gaze instability, throwing balls, cognitive challenges ect) or walking obstacles (stepping over stick, weaving around cones, walking on beams). Exercises are performed between rails and/or with close supervision. Intensity/difficulty of each tasks are individually tailored and progressed based on each participants ability level. Therapists use clinical judgement to challenge the participants balance with each task. Differs from high level group only in starting capacity/ability of participants and subsequently the difficulty level of balance exercises.
Arm 2 ; Land-based exercise-based falls prevention program (High Level). Located in a hospital outpatient facility gymnasium. Ten week (2xweekly), 45-50 min face-to-face exercise sessions facilitated by an accredited exercise physiologist and allied health assistant. Program utilises equipment such as chairs, rails, dura disc, foam, rocker-boards, balls, cones, walking obstacles and steppers. Six participants at a time commencing on a rolling start (ie. participants start when a spot opens and finish after ten weeks). Sessions consist of 5 - 10mins warm-up which includes exercises like walking in the rails in various directions, sit-to-stands/squats and marching on the spot, This is followed by a 35 min circuit of balance tasks such as standing on various unstable surfaces (foam, dura disc, rocker-boards etc), narrowing base of support while multitasking (gaze instability, throwing balls, cognitive challenges ect) or walking obstacles (stepping over stick, weaving around cones, walking on beams). Exercises are performed between rails and/or with close supervision. Intensity/difficulty of each tasks are individually tailored and progressed based on each participants ability level. Therapists use clinical judgement to challenge the participants balance with each task. Differs from low level group only in starting capacity/ability of participants and subsequently the difficulty level and intensity of exercises.
Arm 3: Water-based exercise-based falls prevention program using Ai Chi. Located in a hospital outpatient facility hydrotherapy pool. Ten week (2xweekly), 45-50 min face-to-face exercise sessions facilitated by an accredited exercise physiologist and allied health assistant. Exercise sessions consist of 5-10mins warm-up in the pool followed by 35 mins where participants are directed through a series of Ai Chi postures, There are 19 different postures (or Katas) each progressing in difficulty through different planes of movement and bases of support. Progression and intensity are tailored based on participant ability.

Participant attendance for each group is recorded via attendance checklist and with therapist follow-up (typically phone call) to ensure missing participant is okay and to remind them of next session.
Intervention code [1] 327140 0
Rehabilitation
Intervention code [2] 327141 0
Prevention
Intervention code [3] 327142 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336251 0
Dynamic balance
Timepoint [1] 336251 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks).
Primary outcome [2] 336252 0
Lower-limb Strength
Timepoint [2] 336252 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks).
Secondary outcome [1] 427529 0
Walking speed
Timepoint [1] 427529 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [2] 427530 0
Step-Length
Timepoint [2] 427530 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [3] 427531 0
Walking Endurance
Timepoint [3] 427531 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [4] 427532 0
Fear of Falling
Timepoint [4] 427532 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [5] 427533 0
Physical Activity Level
Timepoint [5] 427533 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [6] 427634 0
Dynamic Balance
Timepoint [6] 427634 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [7] 427635 0
Static balance
Timepoint [7] 427635 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [8] 427636 0
Dynamic Balance
Timepoint [8] 427636 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [9] 427637 0
Dynamic Balance
Timepoint [9] 427637 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [10] 427638 0
Static Balance
Timepoint [10] 427638 0
Baseline (in the week prior to commencing intervention), post-completion of intervention (10-weeks) and 6-months post-completion of intervention (36-weeks)
Secondary outcome [11] 427639 0
Patient Experience
Timepoint [11] 427639 0
Post-Completion of intervention (36-weeks)

Eligibility
Key inclusion criteria
Participants will be recruited for the study from the patients referred to one of the three balance group programs run through the Royal Melbourne Hospital Community Therapy Service. Patients will be identified as suitable candidates for balance group participation through standard care practices including:
- Falls Risk for Older People in the Community (FROP-COM) falls history and other indicators that they require balance specific exercises
- Participants must be able to perform a step test without upper limb support
- Participants must be able to perform a Five times Sit-to-Stand (5x STS)
- Participants must be cognitively able to perform safely in a group environment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are unable to give informed consent or have unstable medical conditions. Another criterion for exclusion is the patient’s inability to follow instructions to a level where they can safely participate in group exercise, for example moderate – severe dementia, reduced cognition, progressive neurological conditions.

Study design
Purpose of the study
Prevention
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 design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/04/2017
Date of last participant enrolment
Anticipated
Actual
3/09/2018
Date of last data collection
Anticipated
Actual
9/04/2019
Sample size
Target
40
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25696 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 41520 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 314965 0
Hospital
Name [1] 314965 0
Royal Melbourne Hospital
Country [1] 314965 0
Australia
Funding source category [2] 315162 0
University
Name [2] 315162 0
La Trobe University
Country [2] 315162 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
34-54 Poplar Road, Parkville Victoria, Australia 3052
Country
Australia
Secondary sponsor category [1] 316962 0
University
Name [1] 316962 0
La Trobe Rural Health School and Holsworth Research Initiative
Address [1] 316962 0
Edwards Rd, Flora Hill , Bendigo, Victoria 3552
Country [1] 316962 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313939 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 313939 0
300 Grattan Street Parkville VIC 3050
Ethics committee country [1] 313939 0
Australia
Date submitted for ethics approval [1] 313939 0
Approval date [1] 313939 0
11/11/2016
Ethics approval number [1] 313939 0

Summary
Brief summary
This study aims to investigate the maintenance or de-training effect of the participants following discharge from the RHM CTS balance programs. It also aims to identify whether or not patients are continuing with physical activity behaviours following discharge and if this has a difference on de-training effects. We hypothesize that the patients who do continue with regular physical activity will have less of a de-training effect then those who do not continue to be active. We hope to identify how we might better encourage a higher rate of continued physical activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129854 0
Mrs Candice Oberholster
Address 129854 0
RMH Physiotherapy Department, 34-54 Poplar Road, Parkville VIC 3052
Country 129854 0
Australia
Phone 129854 0
+61 434976978
Fax 129854 0
Email 129854 0
C.Oberholster@latrobe.edu.au
Contact person for public queries
Name 129855 0
Mrs Candice Oberholster
Address 129855 0
RMH Physiotherapy Department, 34-54 Poplar Road, Parkville VIC 3052
Country 129855 0
Australia
Phone 129855 0
+61 434976978
Fax 129855 0
Email 129855 0
C.Oberholster@latrobe.edu.au
Contact person for scientific queries
Name 129856 0
Mrs Candice Oberholster
Address 129856 0
RMH Physiotherapy Department, 34-54 Poplar Road, Parkville VIC 3052
Country 129856 0
Australia
Phone 129856 0
+61 434976978
Fax 129856 0
Email 129856 0
C.Oberholster@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20602Ethical approval  candice.oberholster@mh.org.au
20603Study protocol  candice.oberholster@mh.org.au
20604Informed consent form  candice.oberholster@mh.org.au



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.