Stronger At Home: Improving Outcomes for Older Adults After Hip Fracture

NCT05972005 | Recruiting

• 1 other identifier: 6032153
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of a new 14-week individually-tailored home-based rehabilitation program called "Stronger at Home" with usual care in improving functional recovery in community-dwelling older adults after hip fractures. The main question this trial aims to answer are:

• Is the Stronger at Home program more effective than usual care in improving functional recovery at the end of the 14-week intervention? secondary questions include:
• What is the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge?
• Does the program have a sustained impact on functional recovery at 6 months and 12 months post-discharge? Participants in the trial will be asked to engage in the following tasks:
• Participate in the Stronger at Home program, which includes using a self-directed toolkit consisting of educational resources and an illustrated exercise program.
• Follow the guidelines provided in the toolkit for gradually increasing exercise intensity and incorporating different types of exercises into their daily life. The effects of the Stronger at Home program will be compared to those of usual care.

Conditions

Hip Fractures

Keywords

Hip Fracture; Exercise program; Recovery; Physical therapy

Outcome Measures

Primary Outcomes (1)

• The Lower Extremity Functional Scale (LEFS)

  The primary outcome of the study (functional abilities) will be assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported outcome measure consisting of 20 items. The LEFS has been validated for various populations, including patients recovering from hip surgeries, and has shown excellent reliability, validity, and responsiveness. It provides a score ranging from 0 to 80 based on the responses to each item's options. The LEFS was chosen based on its ability to evaluate important functional activities for patients, and its use as a primary outcome in the pilot study helped determine the sample size for this trial.

  3.5 months (post intervention )

Secondary Outcomes (8)

• The Short Physical Performance Battery (SPPB)

  Baseline, and at 3.5 months, 6 months, and 12 months after discharge.

• Modified Falls Efficacy Scale

  Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.

• Pain measured with Numerical Analogue Scale (NAS)

  Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.

• Tampa Scale of Kinesiophobia (TSK)

  Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.

• 2-Minute Walk Test (2MWT)

  Baseline, and at 3.5 months, 6 months, and 12 months after discharge.

Other Outcomes (6)

• Health-Related Quality of Life (HRQL)

  Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.

• Quality-Adjusted Life Years (QALYs)

  within 7 days of discharge, as well as within 3.5 months, 6 months, 9 months, and 12 months.

• Charlson Comorbidity Index

  Baseline

Study Arms (2)

Intervention (Stronger at Home model)

EXPERIMENTAL

This study implements a 14-week home-based rehabilitation program for older adults after hip fractures. Participants will receive 8 home visits by a Physiotherapist (PT) and/or Physio assistant(PTA), focusing on individualized exercise programs and pain self-management. The intervention aims to improve functional recovery and includes PT-led assessments, exercise adjustments, and discharge assessments. PTAs support exercise delivery and education. The clinical team comprises PTs and PTAs, receiving training on exercise principles, pain education, and goal setting. The program emphasizes progressive strengthening, balance, and functional exercises, adhering to evidence-based principles. The intervention aims to enhance efficiency, reduce wait times, and promote adherence.

Other: The Intervention (Stronger at Home Intervention)

Control (usual care)

ACTIVE COMPARATOR

The control group will receive usual home care provided by the healthcare system, which could vary between cases. We'll document their received care during follow-ups as it is inconsistent and poorly recorded. Regular check-in calls by the study coordinator will remind them of assessments, reducing attrition.

Other: Usual care (Control)

Interventions

The Intervention (Stronger at Home Intervention) OTHER

The home-based intervention includes 8 visits by a PT and/or PTA. The PT conducts 3 visits for initial assessment, program design, coaching, and discharge assessments. The program targets personal goals and provides pain self-management support. The second PT visit at 6 weeks allows for reassessment and adjustments. The intervention ensures adherence through multiple sessions, tailored exercises, barrier-solving support, and motivational strategies. The PTA conducts solo visits every other week, assisting with exercises and education under PT supervision. This inclusion reduces wait times and improves efficiency. The clinical team consists of at least 2 PTs and 2 PTAs trained for 3 days. The exercise program adheres to evidence-based principles, involving a 30-minute session with warm-up, exercise, and cool-down. Participants are encouraged to exercise 5 times a week, focusing on strengthening, balance, and functionality. Feasible compliance rates were observed in the pilot study.

Also known as: The Stronger at Home Physical Therapy program

Intervention (Stronger at Home model)

Usual care (Control) OTHER

The control group will receive usual home care provided by the healthcare system, which could vary between cases. We'll document their received care during follow-ups as it is inconsistent and poorly recorded. Regular check-in calls by the study coordinator will remind them of assessments, reducing attrition.

Control (usual care)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip fracture patients who are 55 years or older,
• Currently living in the community, and
• Either being discharged to their home or a retirement home
• Fall from a standing height or less
• Live within 45km radius of recruitment site

You may not qualify if:

• Came from long term care or discharged to long term care
• Not a hip fracture (e.g., pelvic fracture)
• Unable to give consent and no proxy
• Fracture due to pathological disease (e.g., cancer, Paget's disease).
• Does not speak English and no translator
• Fracture sustained at hospital
• Terminal illness or exercise contraindications
• Discharged with other services not eligible

Sponsors & Collaborators

• Dr. Mohammad Auais, PhD: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Mohammad Auais

CONTACT

(613) 533-2000; mohammad.auais@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this type of trial, the researchers responsible for assessing the outcomes remain unaware of the treatment assignments. The purpose of single-blind masking is to minimize bias and ensure that the assessment of outcomes is not influenced by researchers' expectations or knowledge of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, School Of Rehabilitation Therapy

Model Details: This randomized controlled trial (RCT) will be conducted over a period of 14 weeks, utilizing a parallel-group design. It will be a single-blind trial, meaning that the assessors will not be aware of participants assigned intervention. The trial will include repeated measures, with follow-ups conducted up to 12 months after the participants are discharged from the hospital. In terms of its design, this trial is considered to be rather pragmatic to very pragmatic, as indicated by a score of 37 out of 45 on the PRECISE-2 tool. The PRECISE-2 tool is used to assess the level of pragmatism in clinical trials, helping to identify trials that closely resemble real-world conditions and are applicable to everyday practice.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 2, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): October 17, 2027
• Study Completion (Estimated): July 29, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)