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Prescribing physical activity for people living in the community following hip fracture

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.

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001101673
Acronym
Nil
Enrollment
21
Registered
2014-10-16
Start date
2014-10-31
Completion date
2016-03-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 feasibly and safely be completed by people who have been recently discharged from hospital after having a hip fracture. The results will help guide therapists as to how much walking they could prescribe to patients living in the community for long-term health benefits.

Interventions

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

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.

Sponsors

Dr. Casey Peiris
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026