Motivational Interventions and Physical Exercise in Patients With Fragility Fracture

NCT ID: NCT04934358

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2024-12-31

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.

Conditions

Fragility Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical activity program and motivational intervention

Physical activity program agreed with the patient / family and according to functional status (based on the 6-minute walk test) and motivational intervention. In addition to the care provided in usual care, a progressive physical exercise program based on basal functional capacity is prescribed. The exercise will be developed at home.

Group Type: EXPERIMENTAL

Physical and motivational follow-up treatment

Intervention Type: BEHAVIORAL

Physical and motivational follow-up treatment

Treatment as usual

Multidisciplinary rehabilitation provided by professionals in the hospital and primary care settings, according to the individual needs of patients at different times of their recovery and the accessibility and availability of services in the different care settings.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Usual rehabilitation program

Interventions

Physical and motivational follow-up treatment

Physical and motivational follow-up treatment

Intervention Type: BEHAVIORAL

Usual care

Usual rehabilitation program

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maimónides Biomedical Research Institute of Córdoba

Córdoba, Cordoba, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Antonio Luque

Role: primary

uicec@imibic.org

0034671596070

Other Identifiers

PIGE-0040-2020

Identifier Type: -

Identifier Source: org_study_id