Motivational interventions and exercise for patients with fragility fractures

Effectiveness of a Follow-up Program Based on Motivational Interventions and Physical Exercise in Patients With Fragility Fracture: Randomized Controlled Clinical Trial.

This study tests if a new motivational program along with exercise can help people recover better after surgery for a hip fracture compared to regular rehab.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Maimónides Biomedical Research Institute of Córdoba (Academic / other)
• Locations: 1 site (Córdoba, Cordoba)
• Trial ID: NCT04934358 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a motivational intervention combined with a physical exercise program on patients who have undergone surgery for a fragility hip fracture. The study is designed as a single-blind, randomized, controlled trial with two parallel arms, comparing the new intervention against usual rehabilitation care. Participants will be followed for three months, with a final assessment at six months to evaluate improvements in functional status, adherence to interventions, and overall quality of life. The trial aims to enhance the recovery process and reduce the risk of future fractures.

Who should consider this trial

Good fit: Ideal candidates are individuals over 50 years old who have recently undergone surgery for a fragility hip fracture and were independent or mildly dependent prior to the fracture.

Not a fit: Patients with severe cognitive impairments or those who do not meet the inclusion criteria for fragility fractures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for patients with fragility fractures.

How similar studies have performed: Previous studies have shown that physical exercise interventions can improve outcomes in similar patient populations, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Present a hip fracture (includes cervical fracture and trochanteric), classified in the 10th version of the International Classification of Diseases (ICD-10-ES) with codes S72-S72.26X;
* In addition, the fracture must be due to fragility: fracture due to a low-energy trauma or not proportional to the consequences (Hermoso de Mendoza, 2003);
* To have received a surgical repair by replacement arthroplasty or internal fixation (ICD-10-ES procedures: 0SU and 0SR) in a period of less than one week;
* To be recovering in a trauma and orthopedic unit and/or be transferred to a rehabilitation unit or discharged;
* Before the fracture, independent or mild dependence for activities of daily living (Barthel index\> 60) and living at home;
* To have the cognitive ability to give informed consent (ANNEX I);
* To live and be domiciled in a basic health area covered by the study hospital complex
* To be over 50 years of age

Exclusion Criteria:

* Presence of low cognitive level (scores below 23 points in Lobo's Mini-cognitive exam);
* Patients with pathological fractures due to skeletal alterations other than osteoporosis;
* Presence of more than one fall (other than the cause of hospital admission) in the last year;
* Presence of uncorrected anemia (hemoglobin concentration \<9/dL), acute infectious disease (C-reactive protein\> 10 mg / L), severe cardiorespiratory disease (for example: unstable angina; severe heart failure identified by the New York Heart Association as class III-IV), musculoskeletal or neurological diseases (for example, major amputation of lower limbs) that make physical exercise impossible.

Where this trial is running

Córdoba, Cordoba

• Maimónides Biomedical Research Institute of Córdoba — Córdoba, Cordoba, Spain (Recruiting)

Conditions Fragility Fracture; fragility fracture; physical exercise; motivational intervention