Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture

Not Applicable

• Conditions: Fall; Frailty Syndrome; Osteoporosis; Hip Fractures; Rehabilitation
• Interventions: Other: ActiveFLS intervention; Other: Usual care group

• Registration Number: NCT05435534
• Lead Sponsor: Fundacion Miguel Servet

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.

Study Timeline

• Study First Submitted: 2022-05-25
• Study Start: 2022-05-26
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-23
• Last Update Submitted: 2022-06-23
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Primary Completion: 2024-01
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multicomponent intervention	ActiveFLS intervention	Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention.
Usual care group	Usual care group	Participants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed.

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	The primary endpoint will be the changes measured at baseline and follow-up

Secondary Outcome Measures

Name	Time	Method
Barthel index	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	Barthel Index of independence during activities of daily living (ADLs). This index ranges from 0 worst to 100 best The endpoint will be the changes measured at baseline and follow-up
Hand grip stength	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	Hand grip strength was measured following the Gronigen Elderly Test using a Smedley Hand Dynamometer. The best of three attempts (with 30 seconds rest between each attempt) was recorded.; The endpoint will be the changes measured at baseline and follow-up
FAC scale	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This index ranges from 0 worst to 5 best; The endpoint will be the changes measured at baseline and follow-up
GDS scale	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	Global Deterioration Scale of Reisberg (GDS Reisberg). GDS Reisberg describes 7 clinically distinguishable global stages, from normality (GDS 1) to severe dementia (GDS 7) of the Alzheimer disease.; The endpoint will be the changes measured at baseline and follow-up
Number of Participants with Institutionalization	T2 1month T3 3 months T4 6 months T5 12 months	The endpoint will be the new Number of Participants with institutionalization; The endpoint will be the changes measured at follow-up
Rate of Frailty	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	Fried frailty index . This scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0); The endpoint will be the changes measured at baseline and follow-up
Lawton index	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	Lawton index of independence durante instrumental activities of daily living. This index ranges from 0 worst to 8 best; The endpoint will be the changes measured at baseline and follow-up
Mini- Mental State Examination (MMSE)	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. This index ranges from 0 worst to 30 best The endpoint will be the changes measured at baseline and follow-up
Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	The endpoint will be the changes measured at baseline and follow-up; The EQ records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' Minimum 0 Maximum 100 Higher scores mean a better outcome
Mini Nutritional Assessment (MNA)	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months	Scale to diagnosis of malnutrition. This index ranges from 0 worst to 30 best; The endpoint will be the changes measured at baseline and follow-up
Mortality	T2 1month T3 3 months T4 6 months T5 12 months	The endpoint will be incidence of this event
Admission and readmission to hospital	T2 1month T3 3 months T4 6 months T5 12 months	The endpoint will be incidence of this event
New fractures	T2 1month T3 3 months T4 6 months T5 12 months	The endpoint will be incidence of this event

Trial Locations

Locations (1)

Hospital Universitario de Navarra (HUN); 🇪🇸 Pamplona, Navarra, Spain