Motivational Interventions and Physical Exercise in Patients With Fragility Fracture

NCT04934358 | Recruiting

• 1 other identifier: PIGE-0040-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fragility Fracture

Keywords

fragility fracture; physical exercise; motivational intervention

Outcome Measures

Primary Outcomes (2)

• Barthel index

  Functional status for the development of activities of daily living (individual ability to take care of himself)

  6 months

• Number of hospital readmissions

  Other clinical outcomes, such as mortality and all-cause hospitalization,

  6 months

Secondary Outcomes (6)

• Mini-Mental State Examination

  6 months

• Minnesota Leisure Time Physical Activity Questionnaire

  6 months

• Geriatric Depression Scale

  6 months

• Visual analogue scale

  6 months

• Falls Efficacy Scale-International

  6 months

Study Arms (2)

Physical activity program and motivational intervention

EXPERIMENTAL

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.

Behavioral: Physical and motivational follow-up treatment

Treatment as usual

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Physical and motivational follow-up treatment BEHAVIORAL

Physical and motivational follow-up treatment

Physical activity program and motivational intervention

Usual care BEHAVIORAL

Usual rehabilitation program

Treatment as usual

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Maimónides Biomedical Research Institute of Córdoba

Córdoba, Cordoba, 14004, Spain

RECRUITING

Related Publications (1)

• Segura-Ruiz R, Ruiz-Canete M, Munoz-Alonso A, Rivas-Cruces C, Serrano-Lazaro P, Armenteros-Ortiz PJ, Hidalgo-Lopezosa P, Lamberti N, Manfredini F, Lopez-Soto PJ. Effectiveness of a home-based physical exercise intervention in patients with fragility fractures on functional independence and hospital readmissions: a protocol for a randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e101342. doi: 10.1136/bmjopen-2025-101342.

  PMID: 41248369 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: January 10, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

ES (1)