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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Physical and motivational follow-up treatment
Usual rehabilitation program
Maimónides Biomedical Research Institute of Córdoba
Córdoba, Cordoba, Spain
RECRUITINGBarthel index
Functional status for the development of activities of daily living (individual ability to take care of himself)
Time frame: 6 months
Number of hospital readmissions
Other clinical outcomes, such as mortality and all-cause hospitalization,
Time frame: 6 months
Mini-Mental State Examination
A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment
Time frame: 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
Time frame: 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
Time frame: 6 months
Visual analogue scale
A validated, subjective measure for acute and chronic pain
Time frame: 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)
Time frame: 6 months
5-level EQ-5D version
A standardised measure of health-related quality of life
Time frame: 6 months
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