Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture (ActiveFLS)

F

Fundacion Miguel Servet

Status

Enrolling

Conditions

Osteoporosis
Rehabilitation
Hip Fractures
Frailty Syndrome
Fall

Treatments

Other: ActiveFLS intervention
Other: Usual care group

Study type

Interventional

Funder types

Other

Identifiers

NCT05435534
ActiveFLS

Details and patient eligibility

About

Due to the clinical, functional, cognitive and social complexity of older adults after fragility hip fractures (defined as those produced by low-impact trauma), the investigators propose an intervention. This intervention involves a multidisciplinary and multicomponent program consisting of physical exercise with tele-rehabilitation, nutritional assessment and other variables related to comprehensive geriatric assessment. The investigators want to improve functional status, quality of life and prevent new fractures. In addition, the investigators try to optimize treatments and resources based on the functional status of patients and their life expectancies, improving care and healthcare cost

Full description

Study aims Improve functional capacity (Short Physical Performance Battery, SPPB) in older patients with fragility hip fractures through a multidisciplinary and multicomponent program and increase the quality of life (EuroQol-5 Dimension) and reduce the use of resources (admission and readmission to emergency department or in-hospital) at 3, 6 and 12 months compare with usual care Analyze the subgroups of patients that benefit the most from the respective interventions, identifying factors of the patient (sociodemographic, clinical, functional and cognitive) and of the intervention (type of exercise, nutritional supplementation, pain control, etc.), which could explain differences in the effectiveness of the intervention at 3, 6 and 12 months Analyze the effect of multidisciplinary and multicomponent intervention in older adults with hip fracture on cognitive capacity (4-AT, MMSE), risk of falls (number of falls, Falls Efficacy Scale), depression (GDS), pain (VAS), polypharmacy, geriatric syndromes and nutritional status (MNA) compare with usual care at 3, 6 and 12 months Developmentally monitor the changes achieved through the intervention, as well as the factors that determine the perpetuation of the benefits of the long-term. Examine the effect of a multi-component program on muscle mass (DXA), bone formation and resorption (BTMs) at 12 months Estimate the prevalence of frailty, multimorbidity and geriatric syndromes in older adults with fragility hip fracture and the changing at 3, 6 and 12 months. Estimate the use of resources necessary to carry out the intervention program, as well as the average time to carry out the comprehensive geriatric assessment, and which is the most cost/efficient tool in this case. Examine the applicability of a tele-rehabilitation program (ActiveHip) in older adults with hip fracture.

Enrollment

174 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient aged ≥ 75 years.
  • Diagnosis of frailty hip fracture (those produced by low-impact trauma).
  • Absence of terminal-stage disease
  • Barthel scale score ≥ 60 points.
  • Previous independence for wandering measured as FAC ≥6
  • Capability/Support for using ActiveHip+ app

Exclusion criteria

  • Moderate-severe cognitive impairment considered as a Goldberg Global Deterioration Scale score ≥ 5.
  • Refusal to sign the informed consent by the patient / main caregiver / legal guardian or inability to obtain it
  • Secondary osteoporosis
  • Nursing home

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

174 participants in 2 patient groups

Multicomponent intervention
Experimental group
Description:
Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention.
Treatment:
Other: ActiveFLS intervention
Usual care group
Active Comparator group
Description:
Participants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed.
Treatment:
Other: Usual care group

Trial contacts and locations

1

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Central trial contact

Bernardo A Cedeno-Veloz, MD

Data sourced from clinicaltrials.gov

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