Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture

NCT05435534 | Unknown

• 1 other identifier: ActiveFLS
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  The primary endpoint will be the changes measured at baseline and follow-up

  T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months

Secondary Outcomes (13)

• Barthel index

  T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months

• FAC scale

  T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months

• GDS scale

  T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months

• Number of Participants with Institutionalization

  T2 1month T3 3 months T4 6 months T5 12 months

• Hand grip stength

  T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months

Study Arms (2)

Multicomponent intervention

EXPERIMENTAL

Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention.

Other: ActiveFLS intervention

Usual care group

ACTIVE COMPARATOR

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

Other: Usual care group

Interventions

ActiveFLS intervention OTHER

* 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

Multicomponent intervention

Usual care group OTHER

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

Usual care group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Hospital of Navarra: collaborator
• NavarraBiomed Biomedical Research Center: collaborator

Study Sites (1)

Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Osteoporosis; Frailty

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Martinez-Velilla, PhD

  Fundación Instituto de Investigación Sanitaria de Navarra

  STUDY DIRECTOR

Central Study Contacts

Bernardo A Cedeno-Veloz, MD

CONTACT

+34 637418620; ba.cedeno.veloz@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 28, 2022
• Study Start: May 26, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)