Hip FracturesActiveFLSNCT05435534
Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture
A study testing ActiveFLS intervention in people with Hip Fractures and Osteoporosis, run by Fundacion Miguel Servet at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hip Fractures, Osteoporosis, Fall
- What is being tested?
- ActiveFLS intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2022to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra (HUN)
Pamplona, Navarre, 31008
Bernardo Cedeno-Veloz, MD, T +(34) 637418620, ba.cedeno.veloz@navarra.es
About this study
Official title: Effect of a Multicomponent Intervention With Telerehabilitation and Vivifrail on Functional Capacity After Hip Fracture: a Randomized Control Trial
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
Read the 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.
- Conditions
- Hip Fractures, Osteoporosis, Fall, Frailty Syndrome, Rehabilitation
- Being tested
- ActiveFLS intervention, Usual care group
- Medical subject headings
- Hip Fractures, Osteoporosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveFLS interventionOther
- 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 groupOther
Participants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent intervention | Experimental | Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention. Receives: Other: ActiveFLS intervention |
| Usual care group | Active comparator | Participants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed. Receives: Other: Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
The primary endpoint will be the changes measured at baseline and follow-up
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Secondary outcomes (13)
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
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
Measured: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Mortality
The endpoint will be incidence of this event
Measured: T2 1month T3 3 months T4 6 months T5 12 months
Admission and readmission to hospital
The endpoint will be incidence of this event
Measured: T2 1month T3 3 months T4 6 months T5 12 months
New fractures
The endpoint will be incidence of this event
Measured: T2 1month T3 3 months T4 6 months T5 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start26 May 2022
- Primary completionJan 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Navarra, NavarraBiomed Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Nicolas Martinez-Velilla, PhD, Study director, Fundación Instituto de Investigación Sanitaria de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435534
- Sponsor's protocol ID
- ActiveFLS
- Acronym
- ActiveFLS
- Status last verified
- Jun 2022
- First submitted
- 25 May 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share data under reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multicomponent Intervention With Telerehabilitation and Vivifrail on Functional Capacity After Hip Fracture: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05435534
- Acronym / sponsor ID
- ActiveFLS / ActiveFLS
- Conditions
- Hip Fractures, Osteoporosis, Fall, Frailty Syndrome, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Hospital of Navarra, NavarraBiomed Biomedical Research Center
- Study start
- 26 May 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent intervention | Experimental | Other: ActiveFLS interventionParticipants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention. |
| Usual care group | Active comparator | Other: Usual care groupParticipants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Multicomponent intervention |
| Usual care groupParticipants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed. | Other | Usual care group |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: 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
13 secondary outcomes
Barthel index
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
FAC scale
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
GDS scale
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Number of Participants with Institutionalization
Time frame: T2 1month T3 3 months T4 6 months T5 12 months
Hand grip stength
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Rate of Frailty
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Lawton index
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Mini- Mental State Examination (MMSE)
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Mini Nutritional Assessment (MNA)
Time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
Mortality
Time frame: T2 1month T3 3 months T4 6 months T5 12 months
Admission and readmission to hospital
Time frame: T2 1month T3 3 months T4 6 months T5 12 months
New fractures
Time frame: T2 1month T3 3 months T4 6 months T5 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: Yes. We plan to share data under reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Martinez-Velilla, PhD study director
Fundación Instituto de Investigación Sanitaria de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveFLS intervention in people with Hip Fractures and Osteoporosis, run by Fundacion Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernardo A Cedeno-Veloz, MD (+34 637418620, ba.cedeno.veloz@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.