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Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture (ActiveFLS)

Primary Purpose

Hip Fractures, Osteoporosis, Fall

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ActiveFLS intervention
Usual care group
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de Navarra (HUN)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multicomponent intervention

Usual care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Short Physical Performance Battery (SPPB)
The primary endpoint will be the changes measured at baseline and follow-up

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
Mortality
The endpoint will be incidence of this event
Admission and readmission to hospital
The endpoint will be incidence of this event
New fractures
The endpoint will be incidence of this event

Full Information

First Posted
May 25, 2022
Last Updated
June 23, 2022
Sponsor
Fundacion Miguel Servet
Collaborators
Hospital of Navarra, NAVARRABIOMED
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1. Study Identification

Unique Protocol Identification Number
NCT05435534
Brief Title
Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture
Acronym
ActiveFLS
Official Title
Effect of a Multicomponent Intervention With Telerehabilitation and Vivifrail on Functional Capacity After Hip Fracture: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet
Collaborators
Hospital of Navarra, NAVARRABIOMED

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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 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 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 Developmentally monitor the changes achieved through the intervention, as well as the factors that determine the perpetuation of the benefits of the long-term. Examine the effect of a multi-component program on muscle mass (DXA), bone formation and resorption (BTMs) at 12 months 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. 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. Examine the applicability of a tele-rehabilitation program (ActiveHip) in older adults with hip fracture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Osteoporosis, Fall, Frailty Syndrome, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent intervention
Arm Type
Experimental
Arm Description
Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed.
Intervention Type
Other
Intervention Name(s)
ActiveFLS intervention
Intervention Description
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
Intervention Name(s)
Usual care group
Intervention Description
Participants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed.
Primary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
The primary endpoint will be the changes measured at baseline and follow-up
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary Outcome Measure Information:
Title
Barthel index
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
FAC scale
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
GDS scale
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Number of Participants with Institutionalization
Description
The endpoint will be the new Number of Participants with institutionalization The endpoint will be the changes measured at follow-up
Time Frame
T2 1month T3 3 months T4 6 months T5 12 months
Title
Hand grip stength
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Rate of Frailty
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Lawton index
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Mini- Mental State Examination (MMSE)
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Mini Nutritional Assessment (MNA)
Description
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
Time Frame
T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Title
Mortality
Description
The endpoint will be incidence of this event
Time Frame
T2 1month T3 3 months T4 6 months T5 12 months
Title
Admission and readmission to hospital
Description
The endpoint will be incidence of this event
Time Frame
T2 1month T3 3 months T4 6 months T5 12 months
Title
New fractures
Description
The endpoint will be incidence of this event
Time Frame
T2 1month T3 3 months T4 6 months T5 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernardo A Cedeno-Veloz, MD
Phone
+34 637418620
Email
ba.cedeno.veloz@navarra.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Martinez-Velilla, PhD
Organizational Affiliation
IdisNA
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Navarra (HUN)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Cedeno-Veloz, MD
Phone
T +(34) 637418620
Email
ba.cedeno.veloz@navarra.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share data under reasonable request

Learn more about this trial

Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture

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