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Trial registered on ANZCTR
Registration number
ACTRN12613000828729
Ethics application status
Approved
Date submitted
18/07/2013
Date registered
26/07/2013
Date last updated
13/02/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Prescribing physical activity for patients with hip fracture during rehabilitation
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Scientific title
Determining the maximum tolerable dose of prescribed physical activity for patients with hip fracture in inpatient rehabilitation in terms of safety and feasibility
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Secondary ID [1]
282822
0
Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip fracture
289605
0
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Condition category
Condition code
Physical Medicine / Rehabilitation
289942
289942
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0
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Physiotherapy
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Injuries and Accidents
290018
290018
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0
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Fractures
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a phase I dose-response trial to find out how much physical activity, in the form of walking, can be prescribed for people with hip fracture during rehabilitation in terms of safety and feasibility.
In addition to receiving usual rehabilitation care, groups of 3 participants will be individually supervised to walk at a prescribed level of physical activity for 5 consecutive days. This prescribed level of physical activity will not change for individual participants over the 5 days but may escalate for subsequent groups of participants.
The dose level of prescribed physical activity will follow a modified Fibonacci scheme starting with an initial dose of 3 minutes of moderate intensity supervised walking per day for the first group of participants. Moderate intensity walking will be defined as a 3 on the modified Borg 0-10 perceived exertion scale, where 3 = “I am still comfortable but am breathing a little harder.”
Dose escalation will depend on the presence or absence of adverse incidents among the group of 3 participants.
Depending on the feasibility and safety of the prescribed dose of walking, the dose may or may not be escalated between subsequent groups of participants.
Dose escalation will start with early larger dose increments between groups which get smaller for higher doses until the guideline stopping value of 30 minutes of walking per day is reached (i.e. 3, 6, 10, 15, 21, 27, 30 mins).
The trial will stop when/if a group of participants can achieve 30 minutes of prescribed walking as this reflects physical activity guidelines.
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Intervention code [1]
287507
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Rehabilitation
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Comparator / control treatment
There will be no control group but the trial will involve dose comparison.
The first group of participants will walk for 3 minutes per day over 5 consecutive days.
Depending on feasibility and safety, the dose of walking will escalate between groups of participants following a modified Fibonacci scheme of 3, 6, 10, 15, 21, 27 and 30 minutes of walking.
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
289995
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Maximum tolerated dose of physical activity (minutes of walking)
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Assessment method [1]
289995
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Timepoint [1]
289995
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N/A
The maximum tolerated dose of physical activity will be identified when either:
- groups of participants can no longer feasibly and safely complete the prescribed dose of walking
- a group of participants achieves 30 minutes of prescribed walking (as dose escalation will not continue as this value reflects physical activity guidelines)
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Secondary outcome [1]
303740
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Physical activity measures from the ActivPAL activity monitor worn continuously over the 5 day period: steps, time spent walking and time spent in moderate-vigorous physical activity
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Assessment method [1]
303740
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Timepoint [1]
303740
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Day 5 (average per day over 5 days)
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Secondary outcome [2]
303741
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Mobility using the De Morten Mobility Index (DEMMI)
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Assessment method [2]
303741
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Timepoint [2]
303741
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Day 1 and Day 5
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Secondary outcome [3]
303742
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Confidence with mobility using the Ambulatory Self Confidence Questionnaire
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Assessment method [3]
303742
0
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Timepoint [3]
303742
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Day 1 and Day 5
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Eligibility
Key inclusion criteria
Patients will be eligible if they are:
- admitted to rehabilitation following surgical management of a hip fracture
- receive medical approval to participate
- can walk, either independently or with assistance.
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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
Patients will not be eligible to participate if they:
- are admitted with diagnoses other than hip fracture
- are not able to walk
- have moderate to severe cognitive impairment.
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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)
This is a nonrandomised trial. The trial will be a phase I dose-response study using the 3+3 design (Gao et al 2008, Lin and Shih 2001).
Patients will be recruited consecutively and allocated to a prescribed physical activity dose.
The dose level of prescribed physical activity will follow a modified Fibonacci scheme starting with an initial dose of 3 minutes of supervised walking per day for the first group of participants, with early larger dose increments which get smaller for higher doses until the guideline stopping value of 30 minutes of walking per day is reached. Prescribed walking doses will be 3, 6, 10, 15, 21, 27 and 30 mins.
Dose escalation will depend on the presence or absence of adverse incidents.
Thirty minutes is the maximum minutes of prescribed walking per day because if this is achieved without incident it means that participants can safely meet physical activity guidelines for older adults.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a nonrandomised trial.
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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
Other
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Other design features
This is a Phase I dose-response trial.
Groups will be dose comparison.
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
The primary analysis will be based on decision rules described by Lin and Shih (2001) to determine the maximum tolerated dose (minutes of walking) in relation to incidents.
Feasibility will be described by reporting the proportion of participants unable to complete their prescribed walking dose due to reasons other than safety.
To determine if the maximum tolerable dose meets current physical activity guidelines, activity monitor data from the participants who completed the maximum dose will be analysed. Activity monitor data from participants who completed other doses of walking will also be analysed to determine if they met current physical activity guidelines for older adults. Physical activity guidelines will be met if the participant spends at least 30 minutes in moderate intensity physical activity (counted in bouts of 10 minutes or more) on one day or a total of 150 minutes over the 5 days. This physical activity may have been completed during the prescribed walking or at other times (independently or during usual therapy).
Secondary analyses will describe baseline mobility, walking confidence and demographic data. In addition, secondary outcomes will be used for preliminary exploration of any associations between walking dose and change in mobility, confidence or overall activity levels.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/08/2013
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Actual
20/09/2013
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Date of last participant enrolment
Anticipated
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Actual
13/12/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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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]
1278
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Peter James Centre - Forest Hill
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Recruitment postcode(s) [1]
7162
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3151 - Burwood East
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Funding & Sponsors
Funding source category [1]
287604
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University
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Name [1]
287604
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Physical Activity and Rehabilitation Research Group, Faculty of Health Sciences, La Trobe University
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Address [1]
287604
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La Trobe University, Bundoora, Victoria 3086
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Country [1]
287604
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Australia
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Primary sponsor type
Individual
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Name
Nicholas Taylor
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Address
Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
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Country
Australia
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Secondary sponsor category [1]
286352
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Individual
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Name [1]
286352
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Nora Shields
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Address [1]
286352
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Physiotherapy Department
La Trobe University
Bundoora
Victoria
3086
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Country [1]
286352
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Australia
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Secondary sponsor category [2]
286353
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Individual
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Name [2]
286353
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Casey Peiris
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Address [2]
286353
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Allied Health Clinical Research Office
5 Arnold Street
Box Hill
VIC
3128
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Country [2]
286353
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Australia
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Secondary sponsor category [3]
286354
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Individual
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Name [3]
286354
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Genevieve Kennedy
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Address [3]
286354
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Peter James Centre
Mahoneys Road
Burwood East
VIC
3151
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Country [3]
286354
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289579
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Eastern Health Research and Ethics Committee
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Ethics committee address [1]
289579
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Level 3, 5 Arnold Street
Box Hill
VIC
3128
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Ethics committee country [1]
289579
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Australia
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Date submitted for ethics approval [1]
289579
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26/06/2013
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Approval date [1]
289579
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02/09/2013
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Ethics approval number [1]
289579
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EC00211
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Ethics committee name [2]
289580
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La Trobe University Human Ethics Committee
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Ethics committee address [2]
289580
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Human Ethics Committee
La Trobe University
Bundoora
VIC
3086
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Ethics committee country [2]
289580
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Australia
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Date submitted for ethics approval [2]
289580
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Approval date [2]
289580
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Ethics approval number [2]
289580
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EC00226
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Summary
Brief summary
We already know that the amount of walking completed by people in rehabilitation is very low and people find it hard to regain their walking ability in the community after having a hip fracture. This study will find out how much walking can be feasibly and safely completed by people in rehabilitation after having a hip fracture. The results will help guide therapists as to how much walking they could prescribe to optimise patient outcomes.
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Trial website
Nil
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Trial related presentations / publications
Nil
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Public notes
Nil
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Contacts
Principal investigator
Name
41402
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Prof Nicholas Taylor
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Address
41402
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Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
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Country
41402
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Australia
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Phone
41402
0
+613 90918874
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Fax
41402
0
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Email
41402
0
[email protected]
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Contact person for public queries
Name
41403
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Prof Nicholas Taylor
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Address
41403
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Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
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Country
41403
0
Australia
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Phone
41403
0
+613 90918874
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Fax
41403
0
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Email
41403
0
[email protected]
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Contact person for scientific queries
Name
41404
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Prof Nicholas Taylor
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Address
41404
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Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
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Country
41404
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Australia
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Phone
41404
0
+613 90918874
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Fax
41404
0
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Email
41404
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[email protected]
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No information has been provided regarding IPD availability
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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