Motivational Interventions and Physical Exercise in Patients With Fragility Fracture (PREVFRAILTY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fragility Fracture
• Intervention / Treatment: Behavioral: Physical and motivational follow-up treatment; Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Recruiting
      • Maimónides Biomedical Research Institute of Córdoba
      • Contact: Antonio Luque; Phone Number: 0034671596070; Email: uicec@imibic.org
      • Principal Investigator: Pablo Jesús López Soto, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Physical and motivational follow-up treatment; Physical and motivational follow-up treatment
Active Comparator: 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.	Behavioral: Usual care; Usual rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination	A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment	6 months
Minnesota Leisure Time Physical Activity Questionnaire	To assess the quantity (total activity metabolic index) and quality (heavy, moderate, and light) of physical activity performed	6 months
Geriatric Depression Scale	is a brief, 30-item questionnaire in which participants are asked to respond by answering yes or no in reference to how they felt over the past week	6 months
Visual analogue scale	A validated, subjective measure for acute and chronic pain	6 months
Falls Efficacy Scale-International	It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)	6 months
5-level EQ-5D version	A standardised measure of health-related quality of life	6 months

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical exercise; motivational intervention; fragility fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: PIGE-0040-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No