Lower Extremity FracturesNCT07629180
Feasibility of Structured Resistance Training After Lower Extremity Fracture
A study testing Structured Supervised Resistance Training and Coaching Program in people with Lower Extremity Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Adults recovering from surgically managed diaphyseal femur or tibia fractures often experience persistent weakness, pain, and functional limitations despite successful fracture healing. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lower Extremity Fractures
- What is being tested?
- Structured Supervised Resistance Training and Coaching Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2026to 15 Jun 2031
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 65 years
- Diaphyseal femur or tibia fracture treated surgically with locked intramedullary nail fixation
- Cleared for full weight bearing with adequate fracture healing and no major complications
- Able to provide written informed consent in English without an interpreter
- Able to understand instructions and safely participate in supervised exercise
Who cannot join
- Bilateral fractures or open fractures; Polytrauma
- Cognitive impairment affecting participation or ability to provide informed consent
- Severe cardiac, respiratory, or neurological conditions that preclude exercise participation
- Chronic pain syndromes or recent opioid dependence
- Pre-existing severe lower limb disability
- Requires an interpreter for consent or cannot follow exercise instructions independently
- Unable to provide consent due to language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Impact of a Structured, Supervised Exercise Program Following Lower Extremity Fracture: A Pilot Controlled Study
Adults recovering from surgically managed diaphyseal femur or tibia fractures often experience persistent weakness, pain, and functional limitations despite successful fracture healing. This prospective, non-randomized pilot study evaluates the feasibility and acceptability of a structured, supervised resistance training program initiated approximately 12 weeks after surgery, compared with usual postoperative care alone. The study will assess recruitment, adherence, retention, and protocol fidelity, and will collect exploratory patient-reported and physical function outcomes to inform the design of a future randomized controlled trial.
Read the detailed description
This is a prospective, non-randomized, controlled pilot feasibility study enrolling adults aged 20 to 65 years with isolated diaphyseal femur or tibia fractures treated surgically with locked intramedullary nail fixation. Participants will be recruited from routine postoperative fracture clinic visits and enrolled approximately 10 to 14 weeks after injury, once fracture healing has progressed sufficiently to allow full weight bearing and independent participation in supervised exercise.
- Conditions
- Lower Extremity Fractures
- Being tested
- Structured Supervised Resistance Training and Coaching Program
- Keywords
- Femur Shaft fracture, Tibia Shaft Fracture, Postoperative Rehabilitation, Resistance Training, Lower extremity fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Supervised Resistance Training and Coaching ProgramBehavioural
A 12-week structured exercise intervention delivered at a community fitness facility by trained study personnel. The program includes 24 supervised small-group resistance training sessions (two per week, 50-75 minutes each), 12 weekly one-to-one coaching sessions (~30 minutes each), and a brief daily home activity program (10-15 minutes per day). The exercise program follows a criteria-based, progressive strength and conditioning framework including mobility, neuromuscular control, strength, power, and fatigue-resistance components. All sessions are supervised by study personnel, and no gym staff are involved in intervention delivery or data collection.
| Study group | Role | What they receive |
|---|---|---|
| Structured Resistance Training Program | Experimental | Participants with surgically managed diaphyseal femur or tibia fractures who participate in a 12-week structured, supervised resistance training and activity program initiated approximately 12 weeks after surgery, in addition to usual postoperative care. Receives: Behavioral: Structured Supervised Resistance Training and Coaching Program |
| Usual Care Control | No intervention | Participants with surgically managed diaphyseal femur or tibia fractures who receive usual postoperative care without participation in the structured supervised exercise or coaching program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate (participants enrolled per month)
Feasibility will be assessed by the number of participants enrolled per month during the recruitment period.
Measured: Up to 6 months
Adherence to supervised resistance training program (% of prescribed sessions completed)
Adherence will be calculated as the proportion of completed training sessions out of the total prescribed sessions.
Measured: Up to 6 months
Participant retention rate (% completing follow up assessments)
Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.
Measured: Up to 6 months
Secondary outcomes (10)
Patient Specific Functional Scale Score
Patient-reported functional status assessed using the Patient-Specific Functional Scale (PSFS), in which participants rate difficulty performing self-selected activities on a 0-10 scale. Higher scores indicate better function.
Measured: 12, 18, 24, and 52 weeks post-surgery
Health-related quality of life measured using SF-12
Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12). Higher scores indicating better health status.
Measured: 12, 18, 24, and 52 weeks post-surgery
Pain intensity measured using Numeric Pain Rating Scale (0-10)
Pain intensity measured using a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 12, 18, 24, and 52 weeks post-surgery
Short Musculoskeletal Functional Assessment (SMFA) score
Self-reported musculoskeletal function assessed using the Short Musculoskeletal Functional Assessment (SMFA) questionnaire. Scores are reported according to standardized scoring procedures, with higher scores indicating greater functional limitation.
Measured: 12, 18, 24, and 52 weeks post-surgery
Functional Independence Test for Lower Extremity Injuries (FIX-IT) score
Lower extremity functional performance assessed using the Functional Independence Test for Lower Extremity Injuries (FIX-IT), a performance-based measure of functional mobility following lower extremity injury.
Measured: 12, 18, 24, and 52 weeks post-surgery
Lateral movement performance measured using Edgren Sidestep Test (seconds)
Lateral movement and agility assessed using the Edgren Sidestep Test. Performance is recorded as time to completion in seconds.
Measured: 12, 18, 24, and 52 weeks post-surgery
Body weight (kilograms)
Body weight measured in kilograms using a calibrated scale.
Measured: 12, 18, 24, and 52 weeks post-surgery
Body mass index (BMI, kg/m²)
Body mass index calculated as weight in kilograms divided by height in meters squared.
Measured: 12, 18, 24, and 52 weeks post-surgery
Thigh circumference measured in centimeters
Thigh circumference measured in centimeters using a standardized tape measure to assess lower extremity muscle girth.
Measured: 12, 18, 24, and 52 weeks post-surgery
Lower extremity muscle strength measured by exercise research team (force output)
Lower extremity muscle strength assessed using standardized strength testing procedures performed by the exercise research team. Strength outcomes will be reported as force output using consistent measurement methods.
Measured: 12, 18, 24, and 52 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2030 (estimated)
- Study completion15 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity FracturesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629180
- Sponsor's protocol ID
- RETRAIN Study
- Other IDs
- LHSCRI
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of a Structured, Supervised Exercise Program Following Lower Extremity Fracture: A Pilot Controlled Study
- ClinicalTrials.gov ID
- NCT07629180
- Acronym / sponsor ID
- RETRAIN Study
- Conditions
- Lower Extremity Fractures
- Keywords
- Femur Shaft fracture, Tibia Shaft Fracture, Postoperative Rehabilitation, Resistance Training, Lower extremity fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 15 Jun 2031 (estimated)
- First posted
- 5 Jun 2026 (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.
Adults recovering from surgically managed diaphyseal femur or tibia fractures often experience persistent weakness, pain, and functional limitations despite successful fracture healing. This prospective, non-randomized pilot study evaluates the feasibility and acceptability of a structured, supervised resistance training program initiated approximately 12 weeks after surgery, compared with usual postoperative care alone. The study will assess recruitment, adherence, retention, and protocol fidelity, and will collect exploratory patient-reported and physical function outcomes to inform the design of a future randomized controlled trial.
Detailed description
This is a prospective, non-randomized, controlled pilot feasibility study enrolling adults aged 20 to 65 years with isolated diaphyseal femur or tibia fractures treated surgically with locked intramedullary nail fixation. Participants will be recruited from routine postoperative fracture clinic visits and enrolled approximately 10 to 14 weeks after injury, once fracture healing has progressed sufficiently to allow full weight bearing and independent participation in supervised exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Resistance Training Program | Experimental | Behavioral: Structured Supervised Resistance Training and Coaching ProgramParticipants with surgically managed diaphyseal femur or tibia fractures who participate in a 12-week structured, supervised resistance training and activity program initiated approximately 12 weeks after surgery, in addition to usual postoperative care. |
| Usual Care Control | No intervention | –Participants with surgically managed diaphyseal femur or tibia fractures who receive usual postoperative care without participation in the structured supervised exercise or coaching program. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 20 to 65 years
- Diaphyseal femur or tibia fracture treated surgically with locked intramedullary nail fixation
- Cleared for full weight bearing with adequate fracture healing and no major complications
- Able to provide written informed consent in English without an interpreter
- Able to understand instructions and safely participate in supervised exercise
Key exclusion criteria (7 listed)
- Bilateral fractures or open fractures; Polytrauma
- Cognitive impairment affecting participation or ability to provide informed consent
- Severe cardiac, respiratory, or neurological conditions that preclude exercise participation
- Chronic pain syndromes or recent opioid dependence
- Pre-existing severe lower limb disability
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 |
|---|---|---|
| Structured Supervised Resistance Training and Coaching ProgramA 12-week structured exercise intervention delivered at a community fitness facility by trained study personnel. The program includes 24 supervised small-group resistance training sessions (two per week, 50-75 minutes each), 12 weekly one-to-one coaching sessions (~30 minutes each), and a brief daily home activity program (10-15 minutes per day). The exercise program follows a criteria-based, progressive strength and conditioning framework including mobility, neuromuscular control, strength, power, and fatigue-resistance components. All sessions are supervised by study personnel, and no gym staff are involved in intervention delivery or data collection. | Behavioural | Structured Resistance Training Program |
Primary outcome
Recruitment rate (participants enrolled per month)
Time frame: Up to 6 months
Feasibility will be assessed by the number of participants enrolled per month during the recruitment period.
Adherence to supervised resistance training program (% of prescribed sessions completed)
Time frame: Up to 6 months
Adherence will be calculated as the proportion of completed training sessions out of the total prescribed sessions.
Participant retention rate (% completing follow up assessments)
Time frame: Up to 6 months
Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.
10 secondary outcomes
Patient Specific Functional Scale Score
Time frame: 12, 18, 24, and 52 weeks post-surgery
Health-related quality of life measured using SF-12
Time frame: 12, 18, 24, and 52 weeks post-surgery
Pain intensity measured using Numeric Pain Rating Scale (0-10)
Time frame: 12, 18, 24, and 52 weeks post-surgery
Short Musculoskeletal Functional Assessment (SMFA) score
Time frame: 12, 18, 24, and 52 weeks post-surgery
Functional Independence Test for Lower Extremity Injuries (FIX-IT) score
Time frame: 12, 18, 24, and 52 weeks post-surgery
Lateral movement performance measured using Edgren Sidestep Test (seconds)
Time frame: 12, 18, 24, and 52 weeks post-surgery
Body weight (kilograms)
Time frame: 12, 18, 24, and 52 weeks post-surgery
Body mass index (BMI, kg/m²)
Time frame: 12, 18, 24, and 52 weeks post-surgery
Thigh circumference measured in centimeters
Time frame: 12, 18, 24, and 52 weeks post-surgery
Lower extremity muscle strength measured by exercise research team (force output)
Time frame: 12, 18, 24, and 52 weeks post-surgery
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 5 Jun 2026.
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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 Structured Supervised Resistance Training and Coaching Program in people with Lower Extremity Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 7 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: opening soon, as of the sponsor's last update on 5 Jun 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 David Sanders, MD, FRCS(C) Principal Investigator (519-685-8500, david.sanders@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (participants enrolled per month) (time frame: Up to 6 months). The study lists 3 primary outcomes in all. 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 5 Jun 2026.