Fractures, Bone Clinical Trial
Official title:
Integrating Patient-Centered Exercise Coaching Into Primary Care to Reduce Fragility Fracture
The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients with a previous fragility fracture (FF). The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.
The intervention will be held in churches, community centers, and senior residential facilities. Investigators will work with the exercise sites to recruit up to 125 individuals (5 per exercise site location) to serve as the Group leaders at each site location. Group leaders will be trained on the exercises and leadership roles to help lead the group. The investigators will ask them to come at least once per week, so the time commitment is minimal. The investigators will be recruiting 1130 patients who have suffered a fragility fracture and will randomly assign them to one of two conditions: (A) Control Group - Enhanced Usual Care and (B) Intervention Group - Enhanced usual care plus Exercise coaching that includes in-person and phone coach contacts to encourage and support strength, balance and walking activities. *Due to the COVID-19 pandemic, the in-person intervention was stopped in March of 2020 and a Zoom-based virtual intervention was introduced in April of 2020. Participants that join the zoom-based virtual intervention are lead by staffed exercise coaches. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05555459 -
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
|
N/A | |
| Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A | |
| Completed |
NCT03506958 -
Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
|
||
| Completed |
NCT04426981 -
Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
|
N/A | |
| Recruiting |
NCT04389749 -
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
|
N/A | |
| Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
| Recruiting |
NCT05594199 -
Feasibility of a Virtual Smoking Cessation Program
|
N/A | |
| Completed |
NCT04514601 -
A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
|
||
| Completed |
NCT05138640 -
Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
|
||
| Completed |
NCT02272972 -
Performance Improvement Program on Imaging II
|
||
| Completed |
NCT04215315 -
Fracture In Preterm Infants Study (FIPIN Study)
|
||
| Completed |
NCT03219125 -
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
|
||
| Completed |
NCT04151732 -
Factors Associated With Future Fractures in Middle-aged Men and Women
|
||
| Terminated |
NCT05655130 -
Distal Radius Steroid
|
Phase 1 | |
| Completed |
NCT02428244 -
Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients
|
N/A | |
| Recruiting |
NCT04501510 -
Ultrasonography in Fracture Management
|
||
| Completed |
NCT03852095 -
Single Time Management Diseases in Pediatric Traumatology
|
||
| Completed |
NCT04440631 -
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
|
||
| Completed |
NCT03370900 -
Learning Retention in Radiograph Interpretation
|
N/A | |
| Completed |
NCT03819478 -
Utilizing Protein During Weight Loss to Impact Physical Function and Bone
|
N/A |