The Stronger at Home Study

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228068
• Other study ID #: REH-721-18
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Other:
• Rehabilitation Program
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
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
The control group will receive the usual care provided by the healthcare system.

Locations

Country	Name	City	State
Canada	Providence Care Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Mohammad Auais, PhD

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Lower Extremity Functional Scale (LEFS)	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.	Change from baseline (before discharge) to 12 weeks post discharge to home (post intervention)
Secondary	The Short Physical Performance Battery (SPPB)	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.	Change from baseline (before discharge), to 12 weeks weeks post discharge to home