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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04934358
Other study ID # PIGE-0040-2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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