Clinical trial NCT04934358: Motivational Interventions and Physical Exercise in Patients With Fragility Fracture
Official title: Effectiveness of a Follow-up Program Based on Motivational Interventions and Physical Exercise in Patients With Fragility Fracture: Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fragility Fracture
Keywords: fragility fracture
physical exercise
motivational intervention
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.

Detailed description: Method: Single-blind, randomized, controlled clinical study, with 2 parallel arms and single-center. Study subjects: Patients who underwent surgery for a fragility hip fracture between September 2021 and September 2022 in a tertiary hospital in southern Spain. A progressive physical exercise and motivational intervention adjusted for functional capacity will be compared versus usual rehabilitation care. Follow-up of patients for 3 months and a final visit at 6 months. The primary outcome variables will be functional status for the development of activities of daily living (individual ability to care for himself) and number of hospital readmissions (reasons and consequences). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analyzed.

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.

Primary outcomes:
measure: Barthel index
timeFrame: 6 months
measure: Number of hospital readmissions
timeFrame: 6 months
Secondary outcomes:
measure: Mini-Mental State Examination
timeFrame: 6 months
measure: Minnesota Leisure Time Physical Activity Questionnaire
timeFrame: 6 months
measure: Geriatric Depression Scale
timeFrame: 6 months
measure: Visual analogue scale
timeFrame: 6 months
measure: Falls Efficacy Scale-International
timeFrame: 6 months
measure: 5-level EQ-5D version
timeFrame: 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Maimónides Biomedical Research Institute of Córdoba
state: Cordoba
Study officials:
References: