Hip FracturesS@HNCT05972005
Stronger at Home: Improving Outcomes for Older Adults After Hip Fracture
A study testing The Intervention (Stronger at Home Intervention) in people with Hip Fractures, run by Dr. Mohammad Auais, PhD at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- The Intervention (Stronger at Home Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2023to 29 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Queen's University
Kingston, Ontario, K7L 3N6
Mohammad Auais, (613) 533-2000 ext. 33112, mohammad.auais@queensu.ca
About this study
Official title: Stronger at Home: Improve Functional Outcomes for Community-dwelling Older Adults After Hip Fracture
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:
Read more
- 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.
Read the detailed description
The primary research question of this project is whether the Stronger at Home program, a 14-week individually-tailored home-based rehabilitation program, is more effective than usual care in improving functional recovery in community-dwelling older adults after hip fractures. The evaluation of effectiveness will be conducted at the end of the intervention, which is the primary time point.
In addition to the main research question, secondary aims of the project include evaluating the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge. The program's impact on functional recovery will also be assessed at medium-term (6 months) and long-term (12 months) follow-ups after the participants are discharged from the hospital to their homes.
The need for conducting this trial arises from a knowledge gap in effective rehabilitation programs for community-dwelling individuals with hip fractures. The Stronger at Home program was developed through a multistage study incorporating a self-directed toolkit and a new model of care. The development process involved critical analysis of previous programs, adherence to four principles of a successful program, and consultations with researchers, policymakers, older adults, and clinicians. The toolkit includes an educational component and an illustrated exercise program with progressively increasing intensity.
The pilot study of the Stronger at Home program has shown feasibility, with positive feedback from healthcare providers and patients regarding its value.
- Conditions
- Hip Fractures
- Being tested
- The Intervention (Stronger at Home Intervention), Usual care (Control)
- Keywords
- Hip Fracture, Exercise program, Recovery, Physical therapy
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Intervention (Stronger at Home Intervention)Other
Also called The Stronger at Home Physical Therapy program
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3.5 months (post intervention )
Secondary outcomes (8)
The Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) will be used as a secondary measure of physical function. The SPPB is a performance-based assessment that includes three tests: standing balance, gait speed, and chair-rising. The total score ranges from 0 to 12, with higher scores indicating better lower extremity physical performance. The SPPB has been extensively validated and used in geriatric research.
Measured: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
Modified Falls Efficacy Scale
The Modified Falls Efficacy Scale (MFES) is a commonly used self-report measure designed to assess an individual's confidence in their ability to perform daily activities without falling. It evaluates balance confidence and fear of falling in older adults or individuals with balance impairments. The scale consists of various activities or situations in which falls may occur, and respondents rate their level of confidence in performing each task without falling.
The MFES typically consists of 14 or 16 items, and each item is rated on a scale ranging from 0% (no confidence) to 100% (complete confidence). The items cover a wide range of activities, including both basic and more complex tasks such as walking on various surfaces, climbing stairs, reaching overhead, and getting out of a chair.
Measured: 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)
The NAS will be utilized to assess pain intensity. Participants will be asked to rate their pain levels at rest and during walking on a scale ranging from 0 to 10, with higher scores indicating greater pain intensity.
Measured: 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)
The TSK will be employed to measure pain-related fear. It assesses individuals' fear and avoidance of physical activity due to pain and provides insights into how fear influences their functional recovery.
Measured: 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)
The 2MWT will be conducted to evaluate participants' mobility endurance. It measures the distance covered by participants during a 2-minute walk, providing information about their aerobic capacity and endurance.
Measured: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
Clinical Frailty Scale
A summary of the overall level of fitness and/or frailty. Scale of 1-9, with higher scores indicating higher degree of frailty.
Measured: Baseline and 3.5 months, 6 months, 12 months after discharge
Short Depression Scale
A 10-item questionnaire related to feelings of depression in the last week.
Measured: Baseline, and 4.5 months, 7.5 months, 9 months, and 10.5 months after discharge
Short Fear of Falling Scale
Scale used to assess fear of falling, with higher scores indicating greater fear of falling
Measured: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start17 Oct 2023
- Primary completion17 Oct 2027 (estimated)
- Study completion29 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Mohammad Auais, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Mohammad Auais, PhD, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972005
- Sponsor's protocol ID
- 6032153
- Acronym
- S@H
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stronger at Home: Improve Functional Outcomes for Community-dwelling Older Adults After Hip Fracture
- ClinicalTrials.gov ID
- NCT05972005
- Acronym / sponsor ID
- S@H / 6032153
- Conditions
- Hip Fractures
- Keywords
- Hip Fracture, Exercise program, Recovery, Physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Mohammad Auais, PhDUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 17 Oct 2027 (estimated)
- Study completion
- 29 Jul 2028 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary research question of this project is whether the Stronger at Home program, a 14-week individually-tailored home-based rehabilitation program, is more effective than usual care in improving functional recovery in community-dwelling older adults after hip fractures. The evaluation of effectiveness will be conducted at the end of the intervention, which is the primary time point.
In addition to the main research question, secondary aims of the project include evaluating the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge. The program's impact on functional recovery will also be assessed at medium-term (6 months) and long-term (12 months) follow-ups after the participants are discharged from the hospital to their homes.
The need for conducting this trial arises from a knowledge gap in effective rehabilitation programs for community-dwelling individuals with hip fractures. The Stronger at Home program was developed through a multistage study incorporating a self-directed toolkit and a new model of care. The development process involved critical analysis of previous programs, adherence to four principles of a successful program, and consultations with researchers, policymakers, older adults, and clinicians. The toolkit includes an educational component and an illustrated exercise program with progressively increasing intensity.
The pilot study of the Stronger at Home program has shown feasibility, with positive feedback from healthcare providers and patients regarding its value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Stronger at Home model) | Experimental | Other: The Intervention (Stronger at Home 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. |
| Control (usual care) | Active comparator | Other: Usual care (Control)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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Intervention (Stronger at Home Intervention)Also: The Stronger at Home Physical Therapy programThe 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. | Other | Intervention (Stronger at Home model) |
| Usual care (Control)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 | Control (usual care) |
Primary outcome
The Lower Extremity Functional Scale (LEFS)
Time frame: 3.5 months (post intervention )
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.
8 secondary outcomes
The Short Physical Performance Battery (SPPB)
Time frame: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
Modified Falls Efficacy Scale
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
Clinical Frailty Scale
Time frame: Baseline and 3.5 months, 6 months, 12 months after discharge
Short Depression Scale
Time frame: Baseline, and 4.5 months, 7.5 months, 9 months, and 10.5 months after discharge
Short Fear of Falling Scale
Time frame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Intervention (Stronger at Home Intervention) in people with Hip Fractures, run by Dr. Mohammad Auais, PhD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Auais ((613) 533-2000 ext. 33112, mohammad.auais@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Lower Extremity Functional Scale (LEFS) (time frame: 3.5 months (post intervention )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.