RecruitingNot ApplicableNCT04934358

Motivational Interventions and Physical Exercise in Patients With Fragility Fracture

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


Sponsor

Maimónides Biomedical Research Institute of Córdoba

Enrollment

100 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with a fragility fracture are twice as likely to have future fractures compared to their non-fractured peers. Furthermore, the 30% who suffer a fragility fracture do not regain the level of functioning in terms of activities of daily living after one year. A recent ecological study, in several European countries, estimates that if fracture patients were enrolled in fracture follow-up services, at least 19,000 fractures could be prevented each year. Clinical trials carried out in the research group have shown that the prescription of physical exercise in severe underlying pathologies is effective in improving physical function, quality of life and long-term results. Hypothesis: The implementation of a motivational intervention and physical exercise program, in a staggered manner, taking into account the basic exercise capacity, improves the functional status of the patient (basic activities of daily life), adherence to interventions and the level of physical activity, and therefore reduces the number of hospital admissions, refractures and other associated complications. Objective: To evaluate the effect of a rehabilitation intervention based on physical exercise and motivation, applied in a staggered manner and according to the functional capacity of patients with fragility fracture.


Eligibility

Min Age: 50 Years

Inclusion Criteria8

  • 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 Criteria4

  • 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.

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Interventions

BEHAVIORALPhysical and motivational follow-up treatment

Physical and motivational follow-up treatment

BEHAVIORALUsual care

Usual rehabilitation program


Locations(1)

Maimónides Biomedical Research Institute of Córdoba

Córdoba, Cordoba, Spain

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NCT04934358


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