Stronger at Home Intervention for Hip Fracture

(S@H Trial)

Overseen By Mohammad Auais

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Queen's University

Disqualifiers: Long term care, Pelvic fracture, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 14 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 14-week home-based rehabilitation program designed to help older adults recover better after a hip fracture. The goal is to determine if the "Stronger at Home" program, which includes personalized exercises and educational materials, is more effective than usual care. Researchers will also assess the program's cost-effectiveness and the longevity of its benefits. The trial seeks participants who are 55 or older, have experienced a hip fracture from a fall, and are returning home or to a retirement home. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Stronger at Home program is safe for improving functional recovery after hip fractures?

Research shows that home-based rehabilitation programs like "Stronger at Home" are usually well-received by older adults recovering from hip fractures. Although specific safety data for "Stronger at Home" is unavailable, similar programs have proven safe. These exercise programs help keep participants safe and lower risks during recovery.

Studies of similar home-based exercise programs have not reported any major negative effects. Participants often see improvements in their physical abilities, indicating these programs are beneficial. Such exercise programs are a standard part of hip fracture recovery, demonstrating their safety.

In summary, while specific data for "Stronger at Home" is lacking, similar programs are generally safe and support the recovery process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stronger at Home intervention because it offers a personalized, home-based rehabilitation approach for hip fracture recovery, which is different from the standard care that often involves generalized, less consistent home care. This program focuses on individualized exercises and pain self-management, delivered through home visits by trained physiotherapists and assistants. By emphasizing progressive strengthening and balance exercises tailored to each patient's needs, the intervention aims to boost recovery efficiency and adherence, potentially reducing wait times and improving outcomes compared to traditional methods.

What evidence suggests that the Stronger at Home program is effective for improving functional recovery after hip fractures?

Research has shown that home-based exercise programs help older adults regain strength, balance, and movement after hip fractures. A review of various studies found that these programs also enhance quality of life and independence. One study found that post-surgery home exercises can significantly improve movement and reduce death rates. Additionally, telerehabilitation, often part of these home programs, enhances hip function and promotes adherence to treatment. In this trial, participants in the "Stronger at Home" intervention arm will undergo a 14-week home-based rehabilitation program, potentially leading to better recovery compared to the control group receiving standard care. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults, aged 65 or above, who have had a hip fracture from a fall and live at home or in a retirement home within 25km of the recruitment site. It's not for those coming from/going to long-term care, with non-hip fractures, unable to consent without help, having fractures due to diseases like cancer, non-English speakers without translators, injured in hospital, terminally ill or advised against exercise.

Inclusion Criteria

I am 65 or older and have a hip fracture.

Currently living in the community

Live within 25km radius of recruitment site

Exclusion Criteria

I have had a fracture because of a disease like cancer.

Fracture sustained at hospital

Discharged with other services not eligible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the 14-week Stronger at Home program, which includes a self-directed toolkit with educational resources and an illustrated exercise program. Participants receive 8 home visits by a Physiotherapist (PT) and/or Physio assistant (PTA) for individualized exercise programs and pain self-management.

14 weeks

8 home visits

Follow-up

Participants are monitored for functional recovery and cost-utility at 3.5 months, 6 months, and 12 months post-discharge.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Stronger at Home
• Usual care

Trial Overview The trial tests 'Stronger at Home,' an individualized 14-week home rehab program versus usual care post-hip fracture. The study measures how well participants recover functionally by the end of the program and checks its cost-effectiveness and long-term benefits up to one year after discharge.

How Is the Trial Designed?

Group I: Intervention (Stronger at Home model) Experimental Treatment 1 Intervention

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.

Group II: Control (usual care) Active Control 1 Intervention

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.

Stronger at Home is already approved in Canada for the following indications:

Approved in Canada as Stronger at Home for:

• Rehabilitation after hip fractures in community-dwelling older adults

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Dr. Mohammad Auais, PhD

Lead Sponsor

Trials

3

Recruited

270+

Dr. Mohammad Auais, PhD

Lead Sponsor

Trials

3

Recruited

270+

Published Research Related to This Trial

Accelerated discharge and home-based rehabilitation for hip fracture patients led to greater improvements in physical independence and balance confidence compared to conventional hospital care, with significant results observed at four months.

Patients in the home-based group had shorter hospital stays but longer overall rehabilitation periods, indicating that this approach can be effective without increasing the risk of falls or readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early discharge and home rehabilitation after hip fracture achieves functional improvements: a randomized controlled trial. Crotty, M., Whitehead, CH., Gray, S., et al.[2017]

A 3-month home-based physical therapy program significantly improved hip function and quality of life in patients recovering from hip fractures, with the Harris hip score increasing from 58.6 to 90.1 in the treatment group compared to a smaller increase in the control group.

Patients receiving home-based therapy also reported better psychological and physical health-related quality of life scores at 1 and 3 months post-discharge, indicating that this intervention can enhance overall recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on function and quality of life of postoperative home-based physical therapy for patients with hip fracture. Tsauo, JY., Leu, WS., Chen, YT., et al.[2019]

This non-randomized clinical trial involves 70 patients aged 65 and older who have suffered a hip fracture, comparing a new home-based tele-rehabilitation program to standard outpatient rehabilitation.

The tele-rehabilitation program includes physical exercise and occupational therapy delivered online over 12 weeks, aiming to improve functional recovery and quality of life for patients, while assessing caregiver burden and patient outcomes at multiple time points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home-based tele-rehabilitation protocol for patients with hip fracture called @ctivehip. Ortiz-Piña, M., Salas-Fariña, Z., Mora-Traverso, M., et al.[2019]

A home exercise program significantly improved quadriceps strength and walking velocity in older adults recovering from hip fractures, with 42 participants aged 64 to 94 involved in the study.

Participants in the exercise group also reported a reduced risk of falls, while the control group showed no significant improvements, highlighting the potential benefits of targeted rehabilitation after hip fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home exercise to improve strength and walking velocity after hip fracture: a randomized controlled trial. Sherrington, C., Lord, SR.[2022]

A randomized controlled trial involving 66 older adults showed that early discharge with home-based rehabilitation after a hip fracture led to similar patient outcomes compared to conventional hospital rehabilitation at 12 months.

Caregivers of patients who received home-based therapy reported a significant reduction in their burden, indicating that home rehabilitation not only benefits patients but also alleviates stress for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and caregiver outcomes 12 months after home-based therapy for hip fracture: a randomized controlled trial. Crotty, M., Whitehead, C., Miller, M., et al.[2019]

The home-based fragility fracture integrated rehabilitation management (H-FIRM) program, when combined with the inpatient FIRM (I-FIRM) program, significantly improved functional outcomes in older patients after hip fracture surgery compared to those who only received the I-FIRM program.

In a study of 32 patients, the intervention group showed meaningful improvements in various mobility and independence measures, indicating that H-FIRM can be an effective rehabilitation strategy for enhancing recovery after hip fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Fragility Fracture Integrated Rehabilitation Management (FIRM) Program in Patients Surgically Treated for Hip Fractures. Choi, JH., Kim, BR., Nam, KW., et al.[2021]

Home-based rehabilitation significantly improves mobility, daily activity, instrumental activity, and balance in patients recovering from hip fractures, based on a meta-analysis of 9 randomized controlled trials involving 887 patients.

Despite these benefits, home-based rehabilitation did not significantly affect outdoor walking, usual or fast gait speed, or emergency department visits, indicating that while it enhances certain physical functions, it may not address all aspects of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of home-based rehabilitation for hip fracture: A meta-analysis of randomized controlled trials. Wu, D., Zhu, X., Zhang, S.[2018]

Home-based rehabilitation (HBR) is a feasible option for older adults recovering from hip fractures, with nearly half of the participants (49.7%) choosing this method over institutional-based rehabilitation (IBR).

Patients who opted for HBR experienced less functional decline and a higher rate of recovery compared to those in IBR, suggesting that HBR may be more effective for maintaining independence in community-dwelling older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of the feasibility of home rehabilitation among elderly people with proximal femoral fractures. Giusti, A., Barone, A., Oliveri, M., et al.[2022]

A retrospective study of 224 patients with hip fractures showed that a home rehabilitation program significantly contributes to faster functional recovery, with 90% of participants achieving their therapeutic goals.

The average duration of hospital stay was 8.4 days, while those in the home rehabilitation program had an average of only 6.5 days, indicating a more efficient recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of a home rehabilitation program after hospitalization in patients with hip fracture]. Lafuente-Sanchis, P., Sánchez-Tormos, E., Calero, I., et al.[2022]

A home-based rehabilitation program for 148 older adults after hip fracture was found to be feasible and effective, with 70% of participants completing the 6-month program and significant improvements in strength, balance, and daily functioning.

Participants showed notable progress, including a 48% increase in knee extension strength and a significant reduction in gait deviations, indicating that targeted rehabilitation can enhance recovery and independence in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic home-based physical and functional therapy for older persons after hip fracture. Tinetti, ME., Baker, DI., Gottschalk, M., et al.[2019]

This multicenter randomized controlled trial will evaluate the effectiveness of the ActiveHip+ smartphone-based rehabilitation program for 104 patients over 65 years old with hip fractures, focusing on improving physical performance and other health outcomes over a 12-week period.

The study aims to provide the first evidence of a multidisciplinary m-Health system's efficacy in hip fracture rehabilitation, potentially offering a new, effective option for recovery at home compared to standard rehabilitation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An m-Health telerehabilitation and health education program on physical performance in patients with hip fracture and their family caregivers: Study protocol for the ActiveHip+ randomized controlled trial. Mora-Traverso, M., Molina-Garcia, P., Prieto-Moreno, R., et al.[2022]

Citations

1. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0315707

A systematic review and meta-analysis of randomized ... Our meta-analysis shows home-based exercise is effective in improving lower extremity strength, balance, mobility, and quality of life in older patients after ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12105132/

a meta-analysis of randomized controlled trials Current evidence suggests that telerehabilitation may help improve hip function, increase functional independence, and improve treatment adherence in patients ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167494318302140

Effectiveness of home based intervention program in ... A significant improvement in mobility and reduction of mortality were achieved by the postoperative care program that could be incorporated into the hip ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1829991

Effect of a Home-Based Exercise Program on Functional ... The use of a home-based functionally oriented exercise program resulted in modest improvement in physical function at 6 months after randomization.

5. mds.marshall.edu mds.marshall.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1017&context=physical_therapy_faculty

Review Article Home-Based Multidisciplinary ... The MHR was found to be more effective compared to the. NT in improving functional status and lower extremity strength in patients with hip fracture surgery.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04228068

Study Details | NCT04228068 | The Stronger at Home Study When returning home following hip fracture surgery, patients are at high risk of adverse outcomes (e.g., secondary fractures, institutionalisation, and death).

7. withpower.com withpower.com/trial/phase-fractures-bone-7-2023-ba559

Stronger at Home Intervention for Hip Fracture (S@H Trial) The studies reviewed focus on the effectiveness of home-based rehabilitation programs for hip fracture recovery, but they do not provide specific safety data.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7360882/

Effectiveness of home-based rehabilitation program in ... Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1878124123000679

Safety-promoting interventions for the older person with hip ... In eight studies analyzed, exercise training emerged as the most effective intervention for promoting the safety of older adults after hip fractures on ...