Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture

Osteoporosis Clinical Trial

— ActiveFLS  

Official title:

Effect of a Multicomponent Intervention With Telerehabilitation and Vivifrail on Functional Capacity After Hip Fracture: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435534
• Other study ID #: ActiveFLS
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: May 2024

Study information

• Verified date: June 2022
• Source: Fundacion Miguel Servet
• Contact: Bernardo A Cedeno-Veloz, MD
• Phone: +34 637418620
• Email: ba.cedeno.veloz[@]navarra.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 ß-hydroxy-ß-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 receive normal outpatient care, including physical rehabilitation when needed.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Navarra (HUN)	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion Miguel Servet	Hospital of Navarra, NAVARRABIOMED

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Barthel index	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	FAC scale	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	GDS scale	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Number of Participants with Institutionalization	The endpoint will be the new Number of Participants with institutionalization; The endpoint will be the changes measured at follow-up	T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Hand grip stength	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Rate of Frailty	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Lawton index	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Mini- Mental State Examination (MMSE)	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Mini Nutritional Assessment (MNA)	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	T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Mortality	The endpoint will be incidence of this event	T2 1month T3 3 months T4 6 months T5 12 months
Secondary	Admission and readmission to hospital	The endpoint will be incidence of this event	T2 1month T3 3 months T4 6 months T5 12 months
Secondary	New fractures	The endpoint will be incidence of this event	T2 1month T3 3 months T4 6 months T5 12 months