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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12624001250527
Ethics application status
Approved
Date submitted
19/09/2024
Date registered
11/10/2024
Date last updated
27/10/2024
Date data sharing statement initially provided
11/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Learning Independent Floor Transfers (LIFT): A pilot feasibility study of a floor transfer training program embedded within a home-based community rehabilitation program for adults at risk of falls
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Scientific title
Learning Independent Floor Transfers (LIFT): A pilot feasibility study of a floor transfer training program embedded within a home-based community rehabilitation program for adults at risk of falls
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Secondary ID [1]
313004
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None
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Universal Trial Number (UTN)
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Trial acronym
LIFT study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Falls
335197
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Condition category
Condition code
Physical Medicine / Rehabilitation
331687
331687
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0
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Physiotherapy
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Public Health
331880
331880
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The LIFT study aims to design and evaluate the feasibility of a 6-week floor transfer training program, called the LIFT program, in adults recently discharged from hospital who are at risk of falls.
During phase 1 (duration 3 months), the LIFT program will be co-designed by people with experience of falls or difficulty getting up off the floor and physiotherapists working in a home-based community rehabilitation program within a large public metropolitan health service in Melbourne, Australia. This process will involve semi-structured interviews with two consumers (duration 1 hour) and two focus groups with eight physiotherapists (duration 1.5 hours) to identify their experiences with floor transfer training, barriers and enablers to practising floor transfers and key design requirements of the LIFT program to support effective implementation of an evidence-based floor transfer training program in a home-based setting. Former patients of the program who undertook some sort of floor transfer practice and all physiotherapists working at least 2 days/week in the Home-Based Community Rehabilitation program will be invited to participate in the interviews which will be conducted by a member of the research team. The LIFT program will then be developed and follow-up interviews with the same consumers (duration 1 hour) and focus-groups with physiotherapists (duration 1.5 hours) will be conducted to gather feedback on program components and refine the program's design.
During phase 2 (duration 6 months), the feasibility and acceptability of the LIFT program will be evaluated with 10 participants and their treating physiotherapists. All physiotherapists working within the Home-Based Community Rehabilitation team will receive 2 hours of face-to-face training from members of the research team on how to deliver the LIFT program. Following this training, physiotherapists will then start screening patients within the Home-Based Community Rehabilitation program on initial assessment for potential inclusion in the study. For patients included in the LIFT study, the LIFT program will be delivered in a person's home and embedded within weekly 60-minute usual-care physiotherapy home visits. The program will be personalised for each participant following clinical assessment. The first session will involve assessment of the participant’s ability to get on and off the floor and training in an appropriate floor transfer technique. The floor transfer technique, or components of the technique, will then be practised each week over the five subsequent sessions, for 20 - 30 minutes each session. The remaining session time will be used to address any other goals identified by the participant. Once participants have mastered the floor transfer technique, it will be practised five times each session to maintain proficiency and incorporated into a regular home exercise program. Training will be performed using a sturdy chair or couch, gym mat and foam cushions as needed. Physiotherapists will also have access to a Raizer II lifting chair, which is a portable battery powered device that can be easily used by a single operator to assist a person up off the floor. The lifting chair will provide safety support to the participant and physiotherapist and be used if the participant is struggling to get up off the floor. Physiotherapists will document the content and duration of each session using a pre-specified treatment record to monitor adherence to the key features of the LIFT program.
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Intervention code [1]
329546
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Rehabilitation
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Intervention code [2]
329629
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
339410
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Feasibility
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Assessment method [1]
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Feasibility will be assessed as a composite outcome. Feasibility will be determined by the proportion of participants who complete all six sessions of the LIFT program, as documented by treating physiotherapists on the treatment record. Additionally, feasibility will be determined by the proportion of participants experiencing, and frequency of, any adverse events (e.g., pain or injury) related to the LIFT intervention. All adverse events will be graded using the Common Terminology for Adverse Events (CTCAE5) and assessed for their relatedness to the LIFT intervention.
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Timepoint [1]
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Immediately following completion of the six-week intervention
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Semi-structured interviews with participants and focus-group interviews with treating physiotherapists. exploring their satisfaction with the LIFT program, positive and negative experiences of training, and physical and psychological outcomes of training
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Timepoint [2]
339411
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Immediately following completion of the six-week intervention
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Primary outcome [3]
339412
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Floor rise independence
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Assessment method [3]
339412
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The ability to transfer from supine to standing will be assessed using a standardised approach. A standard chair will be made available laterally to assist if necessary and the physiotherapist will stand directly behind the participant to avoid directional bias. Floor rise independence will be rated using a seven-item scoring system, adapted from a previous study (Hollands et al., 2022). Participants will be rated as needing total assistance (score 1), assisted (scores 2 – 5), modified independence (e.g., needing use of a chair – score 6 ) or fully independent (score 7), defined as the ability to get up off the floor without aids or assistance from another person (i.e., without physical support or verbal prompting).
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Timepoint [3]
339412
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [1]
439821
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Floor rise time
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Assessment method [1]
439821
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Participants who can get up off the floor without hands-on assistance (a floor rise independence score of 5 – 7) will be timed using a stop watch to transfer from supine to standing. Participants will be instructed to stand up at their own speed comfortably following the “go” command, and timing ceased when in stable stance without compensatory movement or sway. The best of two trials will be recorded.
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Timepoint [1]
439821
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [2]
439822
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Floor rise technique
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Assessment method [2]
439822
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Video footage captured on a mobile phone will be recorded and reviewed to describe the technique used to get up off the floor (e.g., backwards chaining), the type of assistance required (e.g., balance support, help to position hemiparetic leg) and limiting factors to getting up off the floor (e.g., endurance/fatigue, decreased confidence, pain, decreased strength).
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Timepoint [2]
439822
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [3]
439823
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Perceived ability to prevent and manage fall risks (PAPMFR)
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Assessment method [3]
439823
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The six-item PAPMFR scale has been developed for community-dwelling older adults and aims to measure confidence in the ability to prevent and manage falls. Items include the “Ability to prevent falls” and the “Ability to find a way to get up if you fall”. Scores range from 6 – 30 and higher scores indicate greater confidence. The scale has good psychometric properties, such as excellent internal consistency (0.94), good structural validity and construct validity (Yoshikawa & Smith, 2019).
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Timepoint [3]
439823
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [4]
439824
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Confidence to get up off the floor
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Assessment method [4]
439824
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Confidence to get up off the floor will be rated by participants on a scale from 1 (not at all confident) to 10 (very confident).
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Timepoint [4]
439824
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [5]
439825
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5 times sit to stand
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Assessment method [5]
439825
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The 5 times sit to stand test is a timed test using a stop watch that involves standing up and sitting down from a standard height chair five times with arms placed across the chest. A time > 13.6s is predictive of a loss of independence with floor transfers (Ardali et al., 2022). The best of two trials will be recorded.
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Timepoint [5]
439825
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [6]
439826
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Gait speed
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Assessment method [6]
439826
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Gait speed will be calculated by timing participants with a stop watch to walk 4 metres at their usual pace (Abellan van Kan et al., 2009), allowing one metre for acceleration and deceleration at either end. The best of two trials will be recorded.
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Timepoint [6]
439826
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Baseline and immediately following completion of the six-week intervention
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Secondary outcome [7]
440453
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Use of Raizer II lifting chair
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Assessment method [7]
440453
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Treating physiotherapists will record the frequency of use of the Raizer II lifting device to deliver the LIFT program on the treatment record, to inform the practicality of delivering the intervention without specialised equipment.
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Timepoint [7]
440453
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Immediately following completion of the six-week intervention
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Secondary outcome [8]
440454
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Number of sessions required to reach independence
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Assessment method [8]
440454
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Treating physiotherapists will record participants’ floor rise independence weekly on the treatment record. The number of sessions required for participants to become fully independent with floor transfers will be reported to inform the practicality of the 6-week program duration.
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Timepoint [8]
440454
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Immediately following completion of the six-week intervention
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Eligibility
Key inclusion criteria
Inclusion criteria for the LIFT study are:
i) Adults who have been recently discharged from hospital and admitted to the Kingston Home-Based Community Rehabilitation program
ii) Identified to be at risk of falls on physiotherapy assessment
iii) Medically stable
iv) Able to stand unsupported > 30 seconds
v) Able to walk independently indoors with or without aids
vi) Sufficient cognitive capacity and communication ability to follow verbal instructions as judged by their treating physiotherapist
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Given the pragmatic nature of this study, we will minimise study exclusions to those that would reflect rehabilitation program delivery in clinical practice:
i) Has a condition in which kneeling is contraindicated (e.g., recent total knee joint replacement)
ii) Known contraindication to exercise (based on the American College of Sports Medicine guidelines). Contraindications include unstable cardiac disease, uncontrolled severe hypertension (BP > 200/110) and current fever.
iii) Weight > 150 kg (safety limit of Raizer II lifting device)
iv) Already able to get up off the floor independently in the last 12 months without an aid
v) Anticipated length of stay in Home-Based Community Rehabilitation is < 6 weeks
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Descriptive statistics will be used to describe participants’ characteristics. Continuous variables will be summarised using mean (standard deviation) or median (interquartile range) according to data type and distribution. Categorical variables will be reported as counts and percentages. Changes in outcomes will be reported descriptively or assessed using a paired t-test or Wilcoxon signed rank test as appropriate. Although this feasibility study is not adequately powered, statistical testing will be used to identify the sample size for a larger randomised controlled trial. Statistical significance will be set at a two-sided p-value of .05. All analyses will be performed using Stata.
Semi-structured interviews will be audio recorded and transcribed verbatim. Supported by Nvivo 14 software, thematic analysis for the qualitative data will be conducted using Braun and Clarke’s six step inductive approach (Braun & Clarke, 2020). Participant and physiotherapist interview data will be analysed separately, then compared.
To answer research Q1, practicality will be determined by the proportion of participants who complete the LIFT program and the proportion of participants experiencing, and frequency of, any adverse events related to the LIFT intervention.
To answer research Q2, acceptability will be measured by semi-structured interviews with participants and physiotherapists exploring their satisfaction with the LIFT program, positive and negative experiences of training and physical and psychological outcomes.
To answer research Q3, limited efficacy will be assessed by mastery of the skill to get up off the floor independently (% who achieved floor rise independence) and a positive shift in floor rise independence between baseline and follow-up.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27126
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Kingston Centre - Cheltenham
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Recruitment postcode(s) [1]
43204
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3192 - Cheltenham
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Funding & Sponsors
Funding source category [1]
317444
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Hospital
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Name [1]
317444
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Monash Health Allied Health Research Grant
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Address [1]
317444
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Country [1]
317444
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Australia
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Primary sponsor type
Individual
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Name
Katrina Kenah, Physiotherapist, Monash Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319734
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None
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Name [1]
319734
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Address [1]
319734
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Country [1]
319734
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316160
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
316160
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
316160
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Australia
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Date submitted for ethics approval [1]
316160
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21/08/2024
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Approval date [1]
316160
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11/10/2024
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Ethics approval number [1]
316160
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Summary
Brief summary
Falls are common following a hospital admission and many people are unable to get up despite being uninjured, leading to complications from remaining on the ground for a long time, ambulance callouts to assist the person up off the floor but without transport to hospital, or a fear of falling and loss of independence. The LIFT study aims to co-design a training program (LIFT program) that teaches people how to get up off the floor and evaluate its feasibility in adults recently discharged from hospital who are at risk of falls. The LIFT program will be embedded during usual-care physiotherapy home visits as part of a community rehabilitation program. Participants will be assessed on their ability to independently get up off the floor before and after the six-week intervention. Semi-structured interviews and focus groups will be used to explore participants and therapists’ satisfaction and the practicality of delivering the program. It is hypothesised that floor transfer training is practical and acceptable to deliver within a home-based community rehabilitation program, and after 6-weeks of training the majority of participants will be able to independently get up off the floor, with or without using a chair.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Katrina Kenah
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Address
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Monash Health, 400 Warrigal Rd, Cheltenham VIC 3192
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Country
136982
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Australia
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Phone
136982
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+61 416290208
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Fax
136982
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Email
136982
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[email protected]
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Contact person for public queries
Name
136983
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Katrina Kenah
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Address
136983
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Monash Health, 400 Warrigal Rd, Cheltenham VIC 3192
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Country
136983
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Australia
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Phone
136983
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+61 416290208
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Fax
136983
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Email
136983
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[email protected]
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Contact person for scientific queries
Name
136984
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Katrina Kenah
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Address
136984
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Monash Health, 400 Warrigal Rd, Cheltenham VIC 3192
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Country
136984
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Australia
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Phone
136984
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+61 416290208
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Fax
136984
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Email
136984
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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