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Trial registered on ANZCTR


Registration number
ACTRN12618001361291
Ethics application status
Approved
Date submitted
17/07/2013
Date registered
14/08/2018
Date last updated
18/10/2021
Date data sharing statement initially provided
18/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study exploring the effectiveness of the Lifestyle approach to reducing Falls through Exercise (LiFE) in the stroke population.
Scientific title
A pilot study comparing the Lifestyle approach to reducing Falls through Exercise (LiFE) to a usual care approach of education and strengthening for reducing falls at 6 months in community living adults with stroke.
Secondary ID [1] 282845 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 289652 0
Stroke 309220 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289969 289969 0 0
Physiotherapy
Physical Medicine / Rehabilitation 289970 289970 0 0
Occupational therapy
Stroke 296343 296343 0 0
Haemorrhagic
Stroke 308093 308093 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be taught the principles of balance and strength training and actively participate in devising activities that will be implemented in a planned and incremental manner over 12 weeks. Eight balance (including static and dynamic) and six strength (hip, knee and ankle) domains will form the basis of these activities that will be embedded within the individual’s daily activities and weekly routines.
Home visits, conducted by occupational therapists and physiotherapists, will take place once per week in weeks 1-6 and in week 8; length of home visits will be 90 minutes on average. A telephone call will occur in weeks 7 and 9; length of telephone call will be 15 minutes on average. LIFE participants will also use a tally counter to assist with counting activity frequency for their adherence logs. Participants in this group will be given: (i) Support in the adoption of exercises. Social cognitive learning strategies will be utilised based on concepts of enhancing self-efficacy. This includes mastery experiences, teaching simple incremental steps, positive verbal persuasion and self-monitoring (exercise logs). (ii) Assistance in maintenance over the longer term and protection against relapse. Adequate follow up and support helps individuals reflect on barriers and problem solve, and (iii) consideration to safety in performance and incremental progression of exercises. It is important to note that patients after stroke do not currently receive any of these interventions or supports as part of their ongoing community-based rehabilitation or care.
Intervention code [1] 287535 0
Rehabilitation
Comparator / control treatment
Seven strength exercises will be provided to the subject but practiced independently on three days per week, at a time of day chosen by the participant. Exercise program duration will be 45-60 minutes per session. The participant will also be provided with the treating hospital's fall prevention handout. This program is considered to be standard practice with additional support provided by the treating physiotherapist (telephone calls) to encourage strengthening exercises. Telephone calls will be used to maintain study participation, and occur in A telephone call will occur in weeks 7 and 9; length of telephone call will be 15 minutes on average.
Control group
Active

Outcomes
Primary outcome [1] 290021 0
Fall surveillance. The primary outcome in this study is the occurrence of falls. Participants will record on each day if they fall or not on a weekly self-report falls surveillance calendar.
Timepoint [1] 290021 0
3 months
6 months
Secondary outcome [1] 303785 0
Adherence. Participants will track adherence by completing daily exercise logs reporting the domain, level and frequency of the exercises done each week.
Timepoint [1] 303785 0
3 months
6 months
Secondary outcome [2] 303786 0
Balance. Static balance will be measured using hierarchical series of stands with diminishing base of support and vision and dynamic balance by the timed Get up and Go.
Timepoint [2] 303786 0
3 months
Secondary outcome [3] 303787 0
Self efficacy. The Tinetti Falls-Efficacy Scale (FES) will assess situation specific and confidence in avoiding falls when performing basic activities of daily living.
Timepoint [3] 303787 0
3 months
Secondary outcome [4] 303788 0
Habitual physical activity and sedentary behviour evaluation scale which includes items asking questions about the type of physical participation in sedentary, household, work, leisure and sporting activities over the past seven days.
Timepoint [4] 303788 0
3 months
Secondary outcome [5] 303789 0
A self-report functional status questionnaire of 8 domains (ADL and IADL) from NHANES 1 Epidemiological Follow-up Study (1986)
Timepoint [5] 303789 0
3 months

Eligibility
Key inclusion criteria
Community living men and women aged 70 or older who have been admitted to an Alfred Health department or service after stroke, and who recall they have had two or more falls/slips or have had one injurious fall in the past 12 months.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are moderate-severe cognitive problems (as indicated by a score of 18 or less on the Mini Mental State examination or moderate-severe impairment in any category on the Cognistat), no conversational English, inability to ambulate independently, resident in a nursing home or hostel, or any unstable or terminal medical illness which would preclude the planned exercises and is unlikely to resolve (e.g. aortic aneurysm, malignant arrhythmias, critical aortic stenosis, rotator cuff tear & active hernias).

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)
As eligible patients are identified and agree to participate, the on­site investigator will contact a person off­ site who will have 10 sealed condition envelopes. The allocation to the control or treatment group will be advised by phone when the person opens the allocation envelope and this will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer-generated number table by person not involved in the study.
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
Efficacy
Statistical methods / analysis
Data analysis will be by intention to treat. Chi-squared analyses and analysis of variance will be used to assist in detection of differences in baseline variables between intervention and control groups, with post hoc t-tests to determine all pair-wise levels of significance when a significant f-ratio is found. For the primary analysis of falls, analyses will include comparison between groups of: (i) the proportion of people who have one or more falls during the 6 months of follow-up (logistic regression model); and (ii) all falls (Negative Binomial Regression model). Each intervention group will be compared separately to the control group. Exercise adherence rates will be calculated as a percentage of exercise sessions completed divided by the number prescribed (3 per wk) at 3 and 6 months. Analysis of variance will be used to evaluate between-group differences at follow-up. For continuous outcome variables analysis will include repeated measures analysis of variance and comparison between groups of absolute and relative change scores, adjusting for baseline scores (Analysis of covariance, ANCOVA). When ANCOVA models are significant, post hoc t tests will be used to determine which groups differ from each other. Non-parametric tests will be applied to scores that are heavily skewed given the small (pilot) sample size).

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
29/07/2013
Date of last participant enrolment
Anticipated
Actual
15/09/2014
Date of last data collection
Anticipated
Actual
15/12/2014
Sample size
Target
10
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1322 0
The Alfred - Prahran
Recruitment hospital [2] 1323 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 7168 0
3181 - Prahran
Recruitment postcode(s) [2] 7169 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 287624 0
University
Name [1] 287624 0
La Trobe University
Country [1] 287624 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Natasha Lannin
Address
Occupational Therapy Department
The Alfred
55 Commercial Road
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 286368 0
None
Name [1] 286368 0
Address [1] 286368 0
Country [1] 286368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289595 0
The Alfred Health Human Ethics Committee
Ethics committee address [1] 289595 0
55 Commercial Road
Prahran VIC 3181
Ethics committee country [1] 289595 0
Australia
Date submitted for ethics approval [1] 289595 0
22/07/2013
Approval date [1] 289595 0
26/08/2013
Ethics approval number [1] 289595 0
330/13

Summary
Brief summary
Falling is one of the most frequent complications seen in stroke patients early after they are discharged home. Thus, finding ways to prevent falls, especially among individuals prone to repeated falls, is urgent. This study will explore whether this integrated lifestyle approach (LiFE) in reducing falls is able to be used with the stroke population, and if so, whether participants experience similar improvements. The LiFE approach involves embedding balance and strength training within habitual daily routines, and has been shown to be effective for reducing falls in older people without stroke. What is unknown to date is whether this functional based exercise approach is also effective in the specific stroke population.
This study is a pilot study which will test the feasibility of using the LiFE approach to balance and strength training with a group of stroke patients living in Melbourne. The protocol will randomly assign ten (10) participants to one of two groups: the LiFE falls prevention program or a usual care control group. The usual care control group will receive the Alfred Health Occupational Therapy Falls handout, plus 7 strengthening exercises and encouragement to complete these 3 times per week. The LiFE group will receive the balance and strengthening program once per week in their own home. The study period is 10 weeks.
The aim of the study is to determine acceptability of the LiFE approach, as well as to begin to understand its efficacy in the stroke population. Data will be collected at baseline, at 3 months and at 6 months. Findings will not only provide important information on falls prevention rehabilitation for Alfred Health, but will also provide data useful for planning a larger clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41494 0
A/Prof Natasha Lannin
Address 41494 0
Occupational Therapy Department
The Alfred
55 Commercial Road
Prahran VIC 3181
Country 41494 0
Australia
Phone 41494 0
+61 3 94796745
Fax 41494 0
Email 41494 0
[email protected]
Contact person for public queries
Name 41495 0
Natasha Lannin
Address 41495 0
Occupational Therapy Department
The Alfred
55 Commercial Road
Prahran VIC 3181
Country 41495 0
Australia
Phone 41495 0
+61 3 94796745
Fax 41495 0
Email 41495 0
[email protected]
Contact person for scientific queries
Name 41496 0
Lindy Clemson
Address 41496 0
The University of Sydney, School of Occupation & Leisure Sciences C42, Faculty of Health Science, PO Box 170 Lidcombe, 1825
NSW
Country 41496 0
Australia
Phone 41496 0
+61 2 9351 9372
Fax 41496 0
Email 41496 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
Consent was not obtained for data sharing; there was no approval for extended use of data in original approval.


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.