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Trial registered on ANZCTR


Registration number
ACTRN12618000083291p
Ethics application status
Submitted, not yet approved
Date submitted
31/12/2017
Date registered
19/01/2018
Date last updated
20/03/2019
Date data sharing statement initially provided
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity in hospitalised older adults after hip fracture
Scientific title
Increasing physical activity in older adults undergoing rehabilitation after hip fracture: a pilot study
Secondary ID [1] 293313 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip fracture 306046 0
Condition category
Condition code
Musculoskeletal 305184 305184 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305185 305185 0 0
Physiotherapy
Injuries and Accidents 305304 305304 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be prescribed a physical activity protocol dependent on their physical ability at the time. For those who are able to stand and walk, a standing strengthening and functional exercise program will be prescribed in addition to ambulation (aiming maximal tolerance) and functional standing (assisted by gait aid with or without additional hands on assistance as appropriate). This will be aimed at three times per day Monday - Friday, with the prescription of an independent exercise program to be completed independently on the weekend. Physiotherapy exercises will be prescribed by the treating physiotherapist and carried out by either a physiotherapist or an allied health assistant in one to one individual treatment sessions. These sessions will be approximately 20 minutes in duration and completed until hospital discharge.
Attendance at and adherence to exercise protocols will be recorded by their treating physiotherapist/allied health assistant. Exercises will be encouraged at set number of repetitions per the protocol, to fatigue/discomfort. Difficulty will be progressed as the participant progresses in ability.

Participants will also be invited to wear an activity monitor attached to their thigh. The PAL2 and activPAL are accelerometers that have previously been validated in older adults (Raymond et al 2015, Klenk et al 2016). These devices will record participants’ activity levels continuously for 3-5 days on weekdays only. Twice daily skin checks will be undertaken by the physiotherapy/allied health assistants on the wards. These are for comfort and to monitor skin irritation. Participants will wear only one monitor, which will be assigned to each participant that agrees to monitoring - this will be assigned alternatively (i.e. PAL2, then ActivPAL, then PAL2, then ActivPAL etc).

Final physical and discharge outcome measures will be taken 24-48 hours prior to discharge, completed by an assessor blinded to group allocation.
Participants and their families, as well as therapy staff will be invited to take part in a semi-structured interview focussing on satisfaction and participation during the project. Seven participants (and families) and involved ward therapy staff (physios and allied health assistants) will be interviewed.
Physiotherapy will be offered three times per day Monday to Friday: once a day by the treating physiotherapist and twice a day by an allied health assistant, under instruction by the treating physiotherapist.
Participants who are able to stand and transfer with assistance of at most one person will be offered a weight-bearing (standing) exercise program. Standing exercises will be aimed at one to two sets of eight to 12 repetitions (high intensity) of some or all of the following (as prescribed by the physiotherapist):
• hip abduction (affected leg)
• hip flexion (affected leg)
• hip extension (affected leg)
• squats
• heel raises
• sit to stand
• step ups
• side/forward walking at rails

Upper Limb Exercises (+/- weights)
• biceps curls
• shoulder press
• chest press
• triceps from chair (pushing up from chair)
These exercises will be prescribed in addition to: standing balance (unaided +/- reaching out of base of support), and ambulation with gait re-education, distance encouraged to maximal tolerance, with rests as required.

For those who are unable to walk, participants will be prescribed a supine and seated exercise program as well as sitting out of bed (with or without standing, and assisted if required). These exercises may include some or all of the following, at 2x 8-12 repetition maximum:

Supine with slideboard as appropriate:
*Quads over fulcrum
*Static quads
*hip/knee flexion/extension
*hip abduction
*bridging
*ankle dorsiflexion/plantar flexion

Seated:
*knee extension
*static glutes
*upper limb exercises as per the ‘weightbearing protocol’

Participants undertaking both protocols will be encouraged to stand to tolerance (with gait aid/assistance where appropriate and practical), as well as sitting out of bed as medical stability and patient ability allows.
Intervention code [1] 299955 0
Rehabilitation
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304339 0
Measures of participation:

Number of sessions attended per day (and reasons for non-attendance)
Timepoint [1] 304339 0
Session participation will be noted
Primary outcome [2] 304340 0
adverse events - e.g. falls (measured by occurrence and details surrounding falls), mortality
Timepoint [2] 304340 0
Throughout the study. (during hospitalisation until discharge).
Secondary outcome [1] 341634 0
Acceptibility of the program: participant, patient and therapist satisfaction via semi-structured interviews
Timepoint [1] 341634 0
Interviews will aim to be undertaken 24-48 hours prior to discharge,
Secondary outcome [2] 341635 0
most appropriate measure of mobility - mILOA, the DeMorton Mobility Index (DeMMI), Timed Up and Go test, gait speed (via 6 metre walk test). Appropriateness will be assessed by examining 'floor' and 'ceiling' effects of outcome measures on admission and discharge; the most appropriate measure will be the outcome measure that does not have floor or ceiling effects.
Timepoint [2] 341635 0
admission to the study and discharge from the study (ie. discharge from hospital)
Secondary outcome [3] 341636 0
most feasible activity monitor - PAL2 or the ActivPAL3. This will be determined by the % of participants wearing each monitor completing 5 full days of monitoring, taking into account reasons for removal.
Timepoint [3] 341636 0
for 5-7 days during the study (covering at least 5 weekdays).
Secondary outcome [4] 342046 0
Session participation - each session will be timed and recorded, and exercises undertaken will be recorded
Timepoint [4] 342046 0
At each session these outcomes will be recorded.

Eligibility
Key inclusion criteria
Admitted to Caulfield Hospital Aged Care Geriatric Evaluation and Management wards for rehabilitation for a primary diagnosis of an isolated subcapital or intertrochanteric hip fracture, which will have already undergone surgery for fixation including open reduction and internal fixation (ORIF), hemiarthroplasty and total hip replacement.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a subtrochanteric fracture,
those with pelvic or other fractures (e.g. upper limb, ankle, spinal),
those with weight bearing restrictions (i.e. other than full weight bearing or weight bearing as tolerated),
those with pathological fractures and
those with contraindications to exercise (ie medically unstable).

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Safety
Statistical methods / analysis
To determine whether the study protocol was feasible, the number of adverse events and number of sessions participated in and those missed (reported as number and percentage of sessions) as a proportion of the expected number of intervention sessions to be completed will be calculated. The reasons for not participating will also be analysed descriptively.
To determine the most appropriate outcome measure to measure function/mobility in this population, the number of people that were able to complete each measure (i.e. mILOA, DEMMI, TUGT and 6 metre walk test) will be calculated, and data will be examined for floor and ceiling effects.
To examine the acceptability of the protocol to patients and therapists, coding and iterative thematic analysis will be undertaken for the qualitative data collected from the semi-structured interviews.
To examine the most feasible activity monitor to measure upright moving and stationary time, the number of patients completing the 5 day wear time (reported as %) and reasons for non-compliance will be recorded for each device.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2019
Actual
Date of last participant enrolment
Anticipated
21/05/2019
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9654 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 18418 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 297937 0
Hospital
Name [1] 297937 0
Caulfield Hospital
Country [1] 297937 0
Australia
Primary sponsor type
Individual
Name
Melissa Raymond
Address
Physiotherapy Department
Caulfield Hospital
260 Kooyong Road
Caulfield 3162
VIC
Country
Australia
Secondary sponsor category [1] 296999 0
None
Name [1] 296999 0
Address [1] 296999 0
Country [1] 296999 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298982 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 298982 0
Ethics committee country [1] 298982 0
Australia
Date submitted for ethics approval [1] 298982 0
05/01/2018
Approval date [1] 298982 0
21/03/2018
Ethics approval number [1] 298982 0

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

Contacts
Principal investigator
Name 78886 0
Dr Melissa Raymond
Address 78886 0
Caulfield Hospital
Physiotherapy Department
260 Kooyong Road
Caulfield VIC
3162
Country 78886 0
Australia
Phone 78886 0
+613 9076 4927
Fax 78886 0
Email 78886 0
[email protected]
Contact person for public queries
Name 78887 0
Melissa Raymond
Address 78887 0
Physiotherapy Department
Caulfield Hospital
260 Kooyong Road
Caulfield VIC
3162
Country 78887 0
Australia
Phone 78887 0
+613 9076 4927
Fax 78887 0
Email 78887 0
[email protected]
Contact person for scientific queries
Name 78888 0
Melissa Raymond
Address 78888 0
Physiotherapy Department
Caulfield Hospital
260 Kooyong Road
Caulfield
3162 VIC
Country 78888 0
Australia
Phone 78888 0
+613 9076 4927
Fax 78888 0
Email 78888 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?
Outcome measures, demographic data - deidentified
When will data be available (start and end dates)?
immediately following publication and ending 5 years following main results publication
Available to whom?
anyone who wishes to acces it
Available for what types of analyses?
any purpose
How or where can data be obtained?
requirement to sign data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1673Study protocol    Will be available on request to primary investigat... [More Details]



Results publications and other study-related documents

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