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OpenTrials
Completed

NCT Number: NCT04228068

The Stronger at Home Study

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.

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Key information

Age range

65 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence Care Hospital

Kingston, Ontario, K7M 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rehabilitation program

Other

PT visits (two visits): The first visit will happen within a week of discharge. During this visit, the PT will assess participants, tailor the program to their needs, and coach them in carrying out the exercises at home. The last visit will be 12 weeks after the first. During this visit, the PT will reassess the participants and make adjustments to the program. The participants will be encouraged to continue exercising beyond the 12 weeks.

The PTA will visit the participants' homes with the PT and will conduct additional solo visits every other week (i.e. 7 PTA visits in total, in 1st week and at 2, 4, 6, 8, 10, and 12 weeks). The PTA will facilitate and progress the exercise program as prescribed and directed by the PT and help in delivering the education component of the program.

Pain self management

Other

In addition to the exercise program, the intervention group will receive a pain self-management support tailored by the PT to the participants' needs.

Conventional care

Other

The control group will receive the usual care provided by the healthcare system.

Primary outcomes

  1. 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

  1. The Short Physical Performance Battery (SPPB)

    Time frame: Change from baseline (before discharge), to 12 weeks weeks post discharge to home

    The SPPB uses three tests to examine lower extremity physical performance: standing balance, gait speed, and chair-rising tests, and the total score is the sum of the three tests (0-12), with higher scores reflecting better physical function.

Sponsors and collaborators

Lead sponsor

Dr. Mohammad Auais, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2020
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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