Motivational Interventions and Physical Exercise in Patients With Fragility Fracture

Fragility Fracture Clinical Trial

— PREVFRAILTY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934358
• Other study ID #: PIGE-0040-2020
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fragility Fracture

Intervention

Behavioral:
• Physical and motivational follow-up treatment
Physical and motivational follow-up treatment
• Usual care
Usual rehabilitation program

Locations

Country	Name	City	State
Spain	Maimónides Biomedical Research Institute of Córdoba	Córdoba	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel index	Functional status for the development of activities of daily living (individual ability to take care of himself)	6 months
Primary	Number of hospital readmissions	Other clinical outcomes, such as mortality and all-cause hospitalization,	6 months
Secondary	Mini-Mental State Examination	A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment	6 months
Secondary	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
Secondary	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
Secondary	Visual analogue scale	A validated, subjective measure for acute and chronic pain	6 months
Secondary	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
Secondary	5-level EQ-5D version	A standardised measure of health-related quality of life	6 months