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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
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
Secondary ID [1] 282822 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 289605 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289942 289942 0 0
Physiotherapy
Injuries and Accidents 290018 290018 0 0
Fractures

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287507 0
Rehabilitation
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.
Control group
Dose comparison

Outcomes
Primary outcome [1] 289995 0
Maximum tolerated dose of physical activity (minutes of walking)
Timepoint [1] 289995 0
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)
Secondary outcome [1] 303740 0
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
Timepoint [1] 303740 0
Day 5 (average per day over 5 days)
Secondary outcome [2] 303741 0
Mobility using the De Morten Mobility Index (DEMMI)
Timepoint [2] 303741 0
Day 1 and Day 5
Secondary outcome [3] 303742 0
Confidence with mobility using the Ambulatory Self Confidence Questionnaire
Timepoint [3] 303742 0
Day 1 and Day 5

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

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a nonrandomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a Phase I dose-response trial.
Groups will be dose comparison.
Phase
Phase 1
Type of endpoint/s
Safety
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/08/2013
Actual
20/09/2013
Date of last participant enrolment
Anticipated
Actual
13/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1278 0
Peter James Centre - Forest Hill
Recruitment postcode(s) [1] 7162 0
3151 - Burwood East

Funding & Sponsors
Funding source category [1] 287604 0
University
Name [1] 287604 0
Physical Activity and Rehabilitation Research Group, Faculty of Health Sciences, La Trobe University
Country [1] 287604 0
Australia
Primary sponsor type
Individual
Name
Nicholas Taylor
Address
Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
Country
Australia
Secondary sponsor category [1] 286352 0
Individual
Name [1] 286352 0
Nora Shields
Address [1] 286352 0
Physiotherapy Department
La Trobe University
Bundoora
Victoria
3086
Country [1] 286352 0
Australia
Secondary sponsor category [2] 286353 0
Individual
Name [2] 286353 0
Casey Peiris
Address [2] 286353 0
Allied Health Clinical Research Office
5 Arnold Street
Box Hill
VIC
3128
Country [2] 286353 0
Australia
Secondary sponsor category [3] 286354 0
Individual
Name [3] 286354 0
Genevieve Kennedy
Address [3] 286354 0
Peter James Centre
Mahoneys Road
Burwood East
VIC
3151
Country [3] 286354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289579 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 289579 0
Ethics committee country [1] 289579 0
Australia
Date submitted for ethics approval [1] 289579 0
26/06/2013
Approval date [1] 289579 0
02/09/2013
Ethics approval number [1] 289579 0
EC00211
Ethics committee name [2] 289580 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 289580 0
Ethics committee country [2] 289580 0
Australia
Date submitted for ethics approval [2] 289580 0
Approval date [2] 289580 0
Ethics approval number [2] 289580 0
EC00226

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

Contacts
Principal investigator
Name 41402 0
Prof Nicholas Taylor
Address 41402 0
Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
Country 41402 0
Australia
Phone 41402 0
+613 90918874
Fax 41402 0
Email 41402 0
[email protected]
Contact person for public queries
Name 41403 0
Nicholas Taylor
Address 41403 0
Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
Country 41403 0
Australia
Phone 41403 0
+613 90918874
Fax 41403 0
Email 41403 0
[email protected]
Contact person for scientific queries
Name 41404 0
Nicholas Taylor
Address 41404 0
Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
Country 41404 0
Australia
Phone 41404 0
+613 90918874
Fax 41404 0
Email 41404 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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