Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000518268
Ethics application status
Approved
Date submitted
21/02/2018
Date registered
9/04/2018
Date last updated
15/06/2021
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
PAIVE - Preventing Atrophy in Immobile Vulnerable Elderly.
Does high dose exercise or electrical muscle stimulation (compared to standard physiotherapy) improve strength and function in an elderly, immobile, cognitively intact, non-weight bearing, in patient population?
Scientific title
PAIVE - Preventing Atrophy in Immobile Vulnerable Elderly.
Does high dose exercise or electrical muscle stimulation (compared to standard physiotherapy) improve strength and function in an elderly, immobile, cognitively intact, non-weight bearing, in patient population?
Secondary ID [1] 293874 0
Nil known
Universal Trial Number (UTN)
U1111-1208-3935
Trial acronym
PAIVE - Preventing Atrophy in Immobile Vulnerable Elderly
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immobile elderly 306337 0
Lower limb fracture 306952 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305423 305423 0 0
Physiotherapy
Injuries and Accidents 306049 306049 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this study is to evaluate the feasibility of the intervention groups and the selected outcome measures. In particular, we will assess recruitment rates, retention rates, adherence to the intervention, staff workload and feedback and explore any treatment effects on muscle strength and function to inform the design (including sample size) of a larger randomized controlled trial.
The secondary aim of this study is to evaluate quadriceps strength and patient function in 3 different exercise programs (low dose – control, high dose and use of NMES) during the non weight bearing / touch weight bearing period in an elderly, cognitively intact, in-patient population.

STUDY TYPE & DESIGN & SCHEDULE

1. Feasibility Study. Each consenting participant at Western Health will be independently randomized into one of three groups. Participants may transfer between GEM units during the admission or may be transferred to bed based transitional care at Hazeldean (BB TCP). The participants will continue with the treatment group they have been randomized to for the duration of the in-patient stay. If the participant becomes acutely unwell and is transferred to an acute unit then their treatment will need to be suspended and hence they will drop out of the study. If the participant is discharged from hospital during their NWB/TWB period, they will also be withdrawn from the study.
2. Population to be studied: English speaking, elderly >65 years who have a fracture (any) of the lower limb preventing them from walking. They have been instructed to be non weight bearing or touch weight bearing by the orthopedic team for a set time period and are unable to safely mobilise with these restrictions. They are current in-patients of the GEM wards or BB TCP ward at Western Health and are cognitively intact. We will ensure that participants with contraindications to NMES (as per the manufacturers instructions) will be excluded from the study.
3. This study will be conducted only at Western Health, across all 4 sites: Footscray, Sunshine, Williamstown and Transitional Care (Hazeldean).
4. Measuring the strength of the quadriceps muscle will inform us of change within each group in the NWB/TWB period and also difference between groups. The key outcome for measuring functional change will be to measure TUG at discharge. This in conjunction with further information regarding FIM, LOS and DXA / pQCT will inform physiotherapy practice regarding the optimal management of this patient group.
5. Data to be collected includes quadriceps strength (via a dynamometer), DXA / pQCT at mid thigh region / calf region respectively, Functional Independence Measure (FIM), Timed Up and GO (TUG) and hospital length of stay.
6. All data will be collected and stored securely in locked cupboards at each site.
7. There will initially be a screening process to gain informed consent. On initial assessment, quadriceps strength (unaffected leg), FIM and DXA / pQCT scan (Sunshine Hospital participants only) will be collected, as well as data on clinical frailty score, self-reported falls in the past 6 months, and Functional Comorbidity Index score, On completion of non weight bearing / touch weight bearing period quadriceps strength will be tested on both the affected and unaffected lower limbs and also DXA / pQCT scans will be conducted for Sunshine Hospital patients only. On discharge, the functional based outcome measures will be collected (FIM) as well as quadriceps strength via dynamometer and TUG. LOS following completion of the NWB/TWB period will also be calculated.
8. There will be follow up testing at 3 months post cessation of the non weight bearing / touch weight bearing period. All outcome measures will be collected again via the participant attending Sunshine Hospital. There will be 3 attempts made to contact the participant to attend the 3 month follow up. If they are unable to be contacted after 3 reasonable attempts the participant will be classified as loss to follow up.

STANDARD CARE PROCEDURES:
1. Independent written exercse program recorded in exercise diary prescribed for participant during initial assessment by Physiotherapist. Program is individualised to patient. Patient will be asked daily 'Have you completed your exercises today and recorded this in your exercise diary?'. This prompt will be worded by the clinician/AHA exactly as above to ensure consistency between participants.
2. Attendance at group exercise class - conducted by AHA and offered group therapy twice weekly and exercises completed as per group exercise sheet
3. Guided exercise program completed by AHA or physiotherapist once per week (1/2 hour session). Exercises individualised to patient.
Standard care will be delivered to the patient for the duration of their inpatient stay.

ADDITION TO STANDARD CARE
1. NMES (Neuro muscular electrical stimulation) will be completed daily under physiotherapist or AHA supervision. 25mins each leg 4 x weekly as per 'Disuse atrophy' program via Chattanooga Wireless Professional NMES device. This is in addition to standard care procedures and will be delivered to the patient for the duration of their inpatient stay.

Details of NMES Disuse Atrophy Program
warm up contraction active rest final recovery phase
FREQUENCY 6 Hz 35 Hz 4 Hz 3 Hz
DURATION OF RAMP-UP 1.5 s 1.5 s 0.5 s 1.5 s
DURATION OF PHASE 2 min 6 s 7 s 3 min
DURATION OF RAMP-DOWN 2 s 0.75 s 0.5 s 3 s


2. High dose exercise program (frequency of treatment is additional to standard care) and will be completed face to face by the AHA or Physiotherapist treating the patient on the ward. The intervention will occur either at the patient's bedside or in the Physiotherapy gym. An additional 3 x per week (1/2 hour sessions). This additional exercise program will be created by the treating physiotherapist of which the exercises will be individualised to patient. Equipment such as weights or theraband may be used and will be based on the patient's current strength, range of movement and level of function, taking into account the non weight bearing restrictions of the affected lower limb. This is in addition to standard care procedures and will be delivered to the patient for the duration of their inpatient stay.
Intervention code [1] 300136 0
Treatment: Devices
Intervention code [2] 300137 0
Treatment: Other
Intervention code [3] 300138 0
Rehabilitation
Comparator / control treatment
STANDARD CARE PROCEDURES (CONTROL). Duration: length of subacute IP admission.

1. Independent written exercse program recorded in exercise diary prescribed for participant during initial assessment by Physiotherapist. This exercise program is designed to be completed independently by the patient without the supervision of a therapist. Program is individualised to patient meaning the exercises will be prescribed based on the patient's current strength, range of movement and level of function and ability to perform the exercises safely and independently, taking into account the non weight bearing restrictions of the affected lower limb. Patient will be asked daily 'Have you completed your exercises today and recorded this in your exercise diary?'. This prompt will be worded by the clinician/AHA exactly as above to ensure consistency between participants.

2. Attendance at group exercise class - conducted by AHA and offered group therapy twice weekly and exercises completed as per group exercise sheet. Exercises are chair based. Some examples of exercises include: reaching out, shoulder rolls, reaching sideways, bicep curls, shoulder punches, wrist curls, knee extension, hip flexion, toeup/heel up.

3. Guided exercise program completed by AHA or physiotherapist once per week (1/2 hour session). Exercises individualised to patient. This session is in addition to completion of the independent exercise program and may include exercises that the patient cannot perform independently.
Control group
Active

Outcomes
Primary outcome [1] 304555 0
Composite Primary outcome of feasibility including the following;

o Recruitment rate: assessed using study records
o Retention rate: assessed using study records
o Adherence to intervention: assessed using study records and patient diaries
o Staff workload and feedback: assessed by collection of staff feedback from data collection forms
o Percentage of outcome measures collected at all time points: assessed using study records
Timepoint [1] 304555 0
At completion of data collection for all patients (ie. after patient has attended 3 month review following discharge)
Primary outcome [2] 305407 0
Feasibility of using DXA and pQCT scans as outcome measures. These include participant tolerance, technical practicality of assisting frail participants into the correct position and resources (staff time).
Timepoint [2] 305407 0
3 months post discharge
Secondary outcome [1] 342380 0
Quadriceps strength of the affected and unaffected leg using muscle testing dynamometre
Timepoint [1] 342380 0
affected leg - at completion of NWB/TWB period, on discharge and at 3 months post discharge

unaffected leg - at baseline, on completion of NWB/TWB period, on discharge and at 3 months post discharge
Secondary outcome [2] 342381 0
Timed up and go test
Timepoint [2] 342381 0
At discharge and at 3 month review post discharge
Secondary outcome [3] 342382 0
Hospital length of stay
Timepoint [3] 342382 0
On discharge from hospital
Secondary outcome [4] 342383 0
Functional independence measure - The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability. FIM™ is used to track the changes in the functional ability of a patient during an episode of hospital rehabilitation care.
Timepoint [4] 342383 0
Baseline and discharge
Secondary outcome [5] 342384 0
DXA scan will be used to measure mid thigh muscle, bone and fat mass. This measure will be taken in Sunshine Hospital patients only to determine if this is a feasible outcome measure
Timepoint [5] 342384 0
Baseline, completion of WB restrictions and 3 month review post discharge
Secondary outcome [6] 344106 0
pQCT will be used to measure the cross sectional area of the calf region. This measure will be taken in Sunshine Hospital patients only to determine if this is a feasible outcome measure
Timepoint [6] 344106 0
Baseline, completion of WB restrictions and 3 month review post discharge

Eligibility
Key inclusion criteria
- Aged 65 years or greater
- Diagnosis of lower limb fracture in which the orthopaedic team have ordered NWB or TWB restrictions, inclusive of pelvis, hip, knee, ankle or foot fractures
- Unable to mobilise whilst maintaining NWB or TWB
- Must be using a sling hoist, standing hoist, Sara Stedy, or pivot/ slideboard for bed to chair transfers
- Current inpatients of GEM or Bed Based TCP wards at Western Health
- Cognitively intact (MMSE > 24)
- Premorbidly mobilising independently or distantly supervised at least household distances (20 meters) with or without gait aid.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Able to maintain NWB or TWB status and mobilise using a gait aid.
- NWB or TWB due to a diagnosis other than lower limb fracture
- Bilateral lower limb fractures
- Limited premorbid mobility defined as close supervision or assistance, and unable to ambulate household distances (20 meters)
- Use of NMES is contraindicated (see contraindications to NMES below (7.1))
- Non English speaking

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For this project we will be using SNOSE for randomization- sequentially numbered, opaque sealed envelopes.
1) Obtain;
- 24 identical, opaque, letter-sized envelopes
- 12 letter size sheets of single-sided carbon paper
- 2 rolls of household aluminium cooking foil
- Tupperware-style plastic container large enough to hold 24 envelopes.
2) Cut foil into 24 sheets that are of the same width as and twice the height of the envelope
3) Cut carbon paper into 24 envelope sized sheets.
4) Separate the 24 sheets of paper into 3 sets of 8 sheets
5) On one set of paper write low dose, on the second sheet write high dose, and on the third sheet write stims.
6) Fold paper to fit in envelope, then place the carbon paper on top of the folded treatment allocation paper, with carbon side facing the paper and fold foil over the combination. Insert into blank envelope. If the completed insert is placed into envelope properly, the double foil wrapper ensures that the envelope is truly opaque and cannot be read by holding it up against a strong light source.
7) Complete all envelopes, seal each envelope, sign your name, in pen, over the top of the envelope seal.
8) Shuffle the envelopes as you would a deck of cards. Once shuffled very thoroughly, with a firm hand, mark a unique number on the front of each envelope 1 to 24 in pen.
9) Place these envelopes into the plastic container, in numerical order, ready for use. Randomization envelopes must always be opened sequentially (from lowest to highest number).
10) Before opening, make sure the research team member write’s the patient’s study participant number, date, signature on front (so that all of this information is transferred to the treatment allocation paper inside)
11) Ensure that treatment allocation paper is kept as it may be audited at the end of the trial.
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
As this is feasibility study, the sample sizes will be a sample of convenience and the data will be used to power for a subsequent large randomised controlled trial. This number has been chosen based on the number of patients we can feasibly recruit, the staff resources we have requested and the time frame in which we hope to have the feasibility study completed. It will enable us to calculate the power we will need for a full scale randomized controlled trial and give us a clear understanding of adherence, dropout rate and ease of recruiting. Power calculations to be calculated only if this feasibility study leads to a larger randomized controlled trial. The current sample size has been justified above.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
15/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9865 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 9866 0
Williamstown Hospital - Williamstown
Recruitment hospital [3] 9867 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 18650 0
3021 - St Albans
Recruitment postcode(s) [2] 18651 0
3016 - Williamstown
Recruitment postcode(s) [3] 18652 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 298491 0
Charities/Societies/Foundations
Name [1] 298491 0
Western Health Research Foundation
Country [1] 298491 0
Australia
Primary sponsor type
Individual
Name
Lucy Troup
Address
Sunshine Hospital
Furlong Road
Sunshine 3020
Victoria
Country
Australia
Secondary sponsor category [1] 297936 0
Individual
Name [1] 297936 0
Kelly Fleury
Address [1] 297936 0
Sunshine Hospital
Furlong Road
Sunshine 3020
Victoria
Country [1] 297936 0
Australia
Other collaborator category [1] 280005 0
Charities/Societies/Foundations
Name [1] 280005 0
Western Health Research Institute
Address [1] 280005 0
Sunshine Hospital
Furlong Road
Sunshine 3020
Victoria
Country [1] 280005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299478 0
Melbourne Health Ethics Committee
Ethics committee address [1] 299478 0
Ethics committee country [1] 299478 0
Australia
Date submitted for ethics approval [1] 299478 0
06/04/2017
Approval date [1] 299478 0
22/06/2017
Ethics approval number [1] 299478 0
HREC/17/MH/159 2016.344

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

Contacts
Principal investigator
Name 80546 0
Ms Lucy Troup
Address 80546 0
Sunshine Hospital
Furlong Road,
Sunshine 3020
Victoria
Country 80546 0
Australia
Phone 80546 0
+61383451479
Fax 80546 0
Email 80546 0
[email protected]
Contact person for public queries
Name 80547 0
Lucy Troup
Address 80547 0
Sunshine Hospital
Furlong Road,
Sunshine 3020
Victoria
Country 80547 0
Australia
Phone 80547 0
+61383451479
Fax 80547 0
Email 80547 0
[email protected]
Contact person for scientific queries
Name 80548 0
Lucy Troup
Address 80548 0
Sunshine Hospital
Furlong Road,
Sunshine 3020
Victoria
Country 80548 0
Australia
Phone 80548 0
+61383451479
Fax 80548 0
Email 80548 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?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
15/10/18 (start date)
no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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