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Clinical Trials/NCT04228068
NCT04228068CompletedNot Applicable

A Home-Based Rehabilitation Program for Patients With Hip Fracture: A Pilot Randomized Trial

Dr. Mohammad Auais, PhD1 site in 1 country32 target enrollmentStarted: March 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
Change in the Lower Extremity Functional Scale (LEFS)

Study Overview

Brief Summary

Hip fracture is a major health problem facing older adults. Hip fractures result in higher mortality, morbidity, and costs than all other osteoporotic fractures combined. When returning home following hip fracture surgery, patients are at high risk of adverse outcomes (e.g., secondary fractures, institutionalisation, and death).

Objectives: This study aims to finalize and pilot test a new program of care including a user-friendly toolkit containing a home-based physiotherapy exercise and pain management program to help community-dwelling older adults recover after hip fractures.

Methods: This study will be two stages: First, finalizing the program. The investigators have created a self-explanatory toolkit that includes an illustrated exercise program based on a critical analysis of previous programs for hip fracture patients. The investigators will organize focus groups and conduct semi-structured interviews with patients, caregivers, policymakers, and healthcare providers to review the program and provide feedback.

Second, conducting a feasibility study. The investigators will pilot the program in a randomized trial with community-dwelling hip fracture patients and compare the intervention with conventional care.

Expected Outcomes: While the number of hip fracture survivors is increasing, they are becoming frailer, and their functional recovery has not improved, making this study timely and relevant. With the current focus on helping older adults "age in place," the proposed project addresses a vital health system challenge: helping older hip fracture patients access proper rehabilitation, so they can stay independent in their homes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 120 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •hip fracture patients who are 65 years or older
  • •being discharged to home or retirement home .

Exclusion Criteria

  • •participants with a terminal illness or significant contraindications preventing exercising (e.g. rapidly progressing neurological disease),
  • •live away more than 30 km from the centre of the city, and
  • •cannot sign the consent form and no proxy available to sign.

Arms & Interventions

Intervention

Experimental

The exercise program will be for the first 12 weeks after returning home. The intervention will be provided after patients return home. Each patient will receive 7 home visits in total over the intervention period by a physiotherapist (PT) and/or a physiotherapy assistant (PTA). Participants in the intervention group will receive a copy of the Toolkit before discharge from the hospital, and the study coordinator will walk them through it and explain what should be expected during the intervention period.

Intervention: Rehabilitation Program (Other)

Intervention

Experimental

The exercise program will be for the first 12 weeks after returning home. The intervention will be provided after patients return home. Each patient will receive 7 home visits in total over the intervention period by a physiotherapist (PT) and/or a physiotherapy assistant (PTA). Participants in the intervention group will receive a copy of the Toolkit before discharge from the hospital, and the study coordinator will walk them through it and explain what should be expected during the intervention period.

Intervention: Pain self management (Other)

Conventional care

Active Comparator

Usual care

Intervention: Conventional care (Other)

Outcomes

Primary Outcomes

Change in the Lower Extremity Functional Scale (LEFS)

Time Frame: Change from baseline (before discharge) to 12 weeks post discharge to home (post intervention)

The Lower Extremity Functional Scale is a patient-reported outcome measure that consists of 20 items. psychometric properties have been tested and established for different populations including patients after hip surgeries and lower extremity conditions. Score range is 0-80 with higher scores indicating better function.

Secondary Outcomes

  • The Short Physical Performance Battery (SPPB)(Change from baseline (before discharge), to 12 weeks weeks post discharge to home)

Investigators

Sponsor
Dr. Mohammad Auais, PhD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Mohammad Auais, PhD

Assistant Professor

Queen's University

Study Sites (1)

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