Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture

NCT05435534 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2022-06-28

No results posted yet for this study

Summary

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

Conditions

  • Hip Fractures
  • Osteoporosis
  • Fall
  • Frailty Syndrome
  • Rehabilitation

Interventions

OTHER

ActiveFLS intervention

* A comprehensive geriatric assessment with a multicomponent physical exercise program guideline based on ActiveHip+ for 3 months. In the subsequent revisions, exercise guidelines from the Vivifrail program will be given * A protocolized nutritional intervention will be carried out. In case of oral nutritional supplementation, supplements enriched in β-hydroxy-β-methylbutyrate (HMB) will be selected * Osteoporosis treatments according to national guideline * A review and adaptation of the treatment will be carried out according to the STOPP (Screening Tool of Older Persons' Prescriptions) and START (Screening Tool to Alert to Right Treatment) criteria * An approach will be made to the patient's mood and fear of falling. In case of depression, both pharmacological and non-pharmacological approaches will be assessed * Screening for cognitive impairment will be performed. In the event of evidence of memory problems, a recommendations for cognitive stimulation will be delivered

OTHER

Usual care group

Participants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed.

Sponsors & Collaborators

  • Hospital of Navarra

    collaborator OTHER
  • NavarraBiomed Biomedical Research Center

    collaborator OTHER
  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Nicolas Martinez-Velilla, PhD · Fundación Instituto de Investigación Sanitaria de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2024-01-31
Completion
2024-05-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435534 on ClinicalTrials.gov