Clinical trial NCT05435534: Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture
Official title: Effect of a Multicomponent Intervention With Telerehabilitation and Vivifrail on Functional Capacity After Hip Fracture: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Osteoporosis
Fall
Frailty Syndrome
Rehabilitation
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Hospital of Navarra
name: NavarraBiomed Biomedical Research Center
First posted: 2022-06-28
Enrollment: 174
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary outcomes:
measure: Barthel index
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: FAC scale
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: GDS scale
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Number of Participants with Institutionalization
timeFrame: T2 1month T3 3 months T4 6 months T5 12 months
measure: Hand grip stength
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Rate of Frailty
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Lawton index
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Mini- Mental State Examination (MMSE)
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Mini Nutritional Assessment (MNA)
timeFrame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
measure: Mortality
timeFrame: T2 1month T3 3 months T4 6 months T5 12 months
measure: Admission and readmission to hospital
timeFrame: T2 1month T3 3 months T4 6 months T5 12 months
measure: New fractures
timeFrame: T2 1month T3 3 months T4 6 months T5 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra (HUN)
state: Navarra
Study officials:
affiliation: Fundación Instituto de Investigación Sanitaria de Navarra
name: Nicolas Martinez-Velilla, PhD
role: STUDY_DIRECTOR
References: