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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
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
Secondary ID [1] 313004 0
None
Universal Trial Number (UTN)
Trial acronym
LIFT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 335197 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331687 331687 0 0
Physiotherapy
Public Health 331880 331880 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329546 0
Rehabilitation
Intervention code [2] 329629 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339410 0
Feasibility
Timepoint [1] 339410 0
Immediately following completion of the six-week intervention
Primary outcome [2] 339411 0
Acceptability
Timepoint [2] 339411 0
Immediately following completion of the six-week intervention
Primary outcome [3] 339412 0
Floor rise independence
Timepoint [3] 339412 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [1] 439821 0
Floor rise time
Timepoint [1] 439821 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [2] 439822 0
Floor rise technique
Timepoint [2] 439822 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [3] 439823 0
Perceived ability to prevent and manage fall risks (PAPMFR)
Timepoint [3] 439823 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [4] 439824 0
Confidence to get up off the floor
Timepoint [4] 439824 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [5] 439825 0
5 times sit to stand
Timepoint [5] 439825 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [6] 439826 0
Gait speed
Timepoint [6] 439826 0
Baseline and immediately following completion of the six-week intervention
Secondary outcome [7] 440453 0
Use of Raizer II lifting chair
Timepoint [7] 440453 0
Immediately following completion of the six-week intervention
Secondary outcome [8] 440454 0
Number of sessions required to reach independence
Timepoint [8] 440454 0
Immediately following completion of the six-week intervention

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27126 0
Kingston Centre - Cheltenham
Recruitment postcode(s) [1] 43204 0
3192 - Cheltenham

Funding & Sponsors
Funding source category [1] 317444 0
Hospital
Name [1] 317444 0
Monash Health Allied Health Research Grant
Country [1] 317444 0
Australia
Primary sponsor type
Individual
Name
Katrina Kenah, Physiotherapist, Monash Health
Address
Country
Australia
Secondary sponsor category [1] 319734 0
None
Name [1] 319734 0
Address [1] 319734 0
Country [1] 319734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316160 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316160 0
Ethics committee country [1] 316160 0
Australia
Date submitted for ethics approval [1] 316160 0
21/08/2024
Approval date [1] 316160 0
11/10/2024
Ethics approval number [1] 316160 0

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

Contacts
Principal investigator
Name 136982 0
Dr Katrina Kenah
Address 136982 0
Monash Health, 400 Warrigal Rd, Cheltenham VIC 3192
Country 136982 0
Australia
Phone 136982 0
+61 416290208
Fax 136982 0
Email 136982 0
[email protected]
Contact person for public queries
Name 136983 0
Katrina Kenah
Address 136983 0
Monash Health, 400 Warrigal Rd, Cheltenham VIC 3192
Country 136983 0
Australia
Phone 136983 0
+61 416290208
Fax 136983 0
Email 136983 0
[email protected]
Contact person for scientific queries
Name 136984 0
Katrina Kenah
Address 136984 0
Monash Health, 400 Warrigal Rd, Cheltenham VIC 3192
Country 136984 0
Australia
Phone 136984 0
+61 416290208
Fax 136984 0
Email 136984 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


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.