Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001101673
Ethics application status
Approved
Date submitted
3/10/2014
Date registered
16/10/2014
Date last updated
31/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prescribing physical activity for people living in the community following hip fracture
Scientific title
A Phase I Dose-Response design trial to determine the maximum tolerable dose of prescribed physical activity for people living in the community following hip fracture in terms of safety, tolerability and feasibility.
Secondary ID [1] 285036 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 292545 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292851 292851 0 0
Physiotherapy
Injuries and Accidents 292852 292852 0 0
Fractures
Musculoskeletal 293518 293518 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase I dose-response trial designed to find out how much physical activity, in the form of walking, can be prescribed for people living in the community post hip fracture in terms of safety, tolerability and feasibility.
Participants will be individually supervised during their walking by an allied health clinician and can walk with their usual assistive device. Participants will walk for a prescribed period of time (dose level) at a location that is convenient to them. Participants will be instructed to walk at a moderate level of intensity which will be determined by the BORG CR-10 rating of perceived exertion scale, where 3 = moderate “I am still comfortable but am breathing a little harder”. Walking can occur indoors or outdoors and the dose can be spread out over a period of 1 week depending on the participants' needs but participants will be encouraged to complete their physical activity in bouts of 10 minutes or more. For example, dose 3 (35 minutes per week) could be reached in 3 ways: 1) 2 bouts of 10 minutes and one bout of 15 minutes per week; 2) one bout of 25 minutes and one bout of 10 minutes per week; or 3) one bout of 35 minutes per week.
The dose level will follow a modified Fibonacci scheme starting with an initial dose of 10 minutes of supervised walking per week for the first 3 participants, with early larger dose increments which get smaller for higher doses until the guideline stopping value of 150 minutes of walking per week is reached (e.g. 10, 20, 35 etc. minutes). Dose escalation will depend on the presence or absence of adverse events or tolerability issues. One hundred and fifty minutes is the maximum minutes of prescribed walking per week because if this is achieved without incident it means that participants can safely meet physical activity guidelines for older adults.
Each participant will be involved in the study for a period of 7 days only.
Intervention code [1] 289865 0
Rehabilitation
Comparator / control treatment
There will be no control group but the trial will involve dose comparison. The first cohort of 3 participants will walk for the same initial dose of 10 minutes within 1 week. If no participant stops due to an adverse event or the dose not being tolerated, the next cohort of 3 participants receive the next higher dose of 25 minutes. If 1 participant per cohort stops due to an adverse event or the dose not being tolerated, a second cohort of 3 participants are prescribed the same 10 minute dose. If 1 out of 6 participants exhibits an adverse event or does not tolerate the dose, then the study continues as planned at the next higher dose (25 minutes). If 2 or more participants out of the 6 exhibit an adverse event or do not tolerate the dose, the dose escalation stops at that level and the previous dose is considered as the maximum tolerated dose.
Control group
Dose comparison

Outcomes
Primary outcome [1] 292726 0
Maximum tolerated dose of physical activity (minutes of walking per week) for people living in the community post hip fracture
Timepoint [1] 292726 0
The maximum tolerated dose of physical activity will be identified when either:
1) A cohort of participants cannot complete the dose of physical activity due to safety or tolerability issues
2) A cohort of participants achieve 150 minutes of prescribed walking within 1 week. Dose escalation will not occur if this dose of physical activity is achieved as this amount fulfills current physical activity guidelines.
Secondary outcome [1] 309557 0
Walking confidence using the Ambulatory Self Confidence Questionnaire
Timepoint [1] 309557 0
Day 7
Secondary outcome [2] 309558 0
Mobility using the De Morten Mobility Index (DEMMI)
Timepoint [2] 309558 0
Day 7

Eligibility
Key inclusion criteria
Participants will be eligibile if they live independently in the community following surgical management of a hip fracture within the previous 6 months, are able to participate safely in moderate intensity physical activity and can walk independently, with or without a gait aid.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with moderate or severe cognitive impairment will not be eligible to participate because they may not be able to take part in the questionnaire process or adequately alert the investigators if they develop concerning symptoms.

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 trial will follow a Phase I dose-response design.
Participants will be recruited consecutively and allocated to a prescribed physical activity dose.
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 using an algorithm-based A+B design; the 3+3 design. These designs are commonly used to determine the maximum tolerable dose for medications.
Participants will be consecutively assigned to a dose level according to the algorithm.
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 of physical activity (minutes of walking) in relation to adverse events and tolerability issues.
Feasibility issues will be classified separately and refer to issues preventing participation but not resulting from participation. These will be described.

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 or confidence and any associations between maximum dose and participant characteristics.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment stopped after 21 participants as the maximum tolerated dose was reached therefore no need to continue recruitment.
Date of first participant enrolment
Anticipated
20/10/2014
Actual
31/10/2014
Date of last participant enrolment
Anticipated
31/03/2016
Actual
30/03/2016
Date of last data collection
Anticipated
Actual
5/04/2016
Sample size
Target
48
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2762 0
Bundoora Extended Care Centre - Bundoora
Recruitment hospital [2] 2763 0
Broadmeadows Health Service - Broadmeadows
Recruitment postcode(s) [1] 8460 0
3083 - Bundoora
Recruitment postcode(s) [2] 8461 0
3047 - Broadmeadows

Funding & Sponsors
Funding source category [1] 289641 0
University
Name [1] 289641 0
Physical Activity and Rehabilitation Research Group, Faculty of Health Sciences, La Trobe University
Country [1] 289641 0
Australia
Funding source category [2] 289642 0
Charities/Societies/Foundations
Name [2] 289642 0
Northern Health Foundation
Country [2] 289642 0
Australia
Primary sponsor type
Individual
Name
Dr. Casey Peiris
Address
Physiotherapy Department
La Trobe University
Bundoora
VIC 3086
Country
Australia
Secondary sponsor category [1] 288331 0
Individual
Name [1] 288331 0
Prof. Nora Shields
Address [1] 288331 0
Physiotherapy Department
La Trobe University
Bundoora
VIC
3086
Country [1] 288331 0
Australia
Secondary sponsor category [2] 288332 0
Individual
Name [2] 288332 0
Dr. Michael Kingsley
Address [2] 288332 0
Faculty of Health Sciences
La Trobe University
Flora Hill Campus
Edwards Road
Bendigo
VIC
3550
Country [2] 288332 0
Australia
Secondary sponsor category [3] 288333 0
Individual
Name [3] 288333 0
Mr. Raphael Hau
Address [3] 288333 0
The Northern Hospital
185 Cooper Street
Epping
VIC
3076
Country [3] 288333 0
Australia
Secondary sponsor category [4] 288336 0
Individual
Name [4] 288336 0
Prof. Nicholas Taylor
Address [4] 288336 0
Physiotherapy Department
La Trobe University
Bundoora
VIC 3086
Country [4] 288336 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291382 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 291382 0
Ethics committee country [1] 291382 0
Australia
Date submitted for ethics approval [1] 291382 0
03/06/2014
Approval date [1] 291382 0
17/06/2014
Ethics approval number [1] 291382 0
EC00423
Ethics committee name [2] 291383 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 291383 0
Ethics committee country [2] 291383 0
Australia
Date submitted for ethics approval [2] 291383 0
08/07/2014
Approval date [2] 291383 0
11/07/2014
Ethics approval number [2] 291383 0
EC00226

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

Contacts
Principal investigator
Name 50130 0
Dr Casey Peiris
Address 50130 0
Physiotherapy Department
La Trobe University
Bundoora
VIC 3086
Country 50130 0
Australia
Phone 50130 0
+613 94795852
Fax 50130 0
Email 50130 0
[email protected]
Contact person for public queries
Name 50131 0
Casey Peiris
Address 50131 0
Physiotherapy Department
La Trobe University
Bundoora
VIC 3086
Country 50131 0
Australia
Phone 50131 0
+613 94795852
Fax 50131 0
Email 50131 0
[email protected]
Contact person for scientific queries
Name 50132 0
Casey Peiris
Address 50132 0
Physiotherapy Department
La Trobe University
Bundoora
VIC 3086
Country 50132 0
Australia
Phone 50132 0
+613 94795852
Fax 50132 0
Email 50132 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseMaximum Tolerated Dose of Walking for Community-Dwelling People Recovering From Hip Fracture: A Dose-Response Trial.2017https://dx.doi.org/10.1016/j.apmr.2017.03.027
N.B. These documents automatically identified may not have been verified by the study sponsor.