Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture

NCT ID: NCT05435534

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2024-05-31

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

Detailed Description

Study aims

1. 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

2. 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

3. 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

4. Developmentally monitor the changes achieved through the intervention, as well as the factors that determine the perpetuation of the benefits of the long-term.

5. Examine the effect of a multi-component program on muscle mass (DXA), bone formation and resorption (BTMs) at 12 months

6. 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.

7. 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.

8. Examine the applicability of a tele-rehabilitation program (ActiveHip) in older adults with hip fracture.

Conditions

Hip Fractures; Osteoporosis; Fall; Frailty Syndrome; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multicomponent intervention

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

Group Type: EXPERIMENTAL

ActiveFLS intervention

Intervention Type: 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

Usual care group

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

Group Type: ACTIVE_COMPARATOR

Usual care group

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Usual care group

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital of Navarra

OTHER

Sponsor Role: collaborator

NavarraBiomed Biomedical Research Center

OTHER

Sponsor Role: collaborator

Fundacion Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Martinez-Velilla, PhD

Role: STUDY_DIRECTOR

Fundación Instituto de Investigación Sanitaria de Navarra

Locations

Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Bernardo A Cedeno-Veloz, MD

Role: CONTACT

ba.cedeno.veloz@navarra.es

+34 637418620

Facility Contacts

Bernardo Cedeno-Veloz, MD

Role: primary

ba.cedeno.veloz@navarra.es

T +(34) 637418620

Other Identifiers

ActiveFLS

Identifier Type: -

Identifier Source: org_study_id