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| Name | Class |
|---|---|
| Hospital of Navarra | OTHER |
| NavarraBiomed Biomedical Research Center | OTHER |
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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
Study aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent intervention | Experimental | Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention. |
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| Usual care group | Active Comparator | Participants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiveFLS intervention | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| FAC scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernardo A Cedeno-Veloz, MD | Contact | +34 637418620 | ba.cedeno.veloz@navarra.es |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Martinez-Velilla, PhD | Fundación Instituto de Investigación Sanitaria de Navarra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Navarra (HUN) | Recruiting | Pamplona | Navarre | 31008 | Spain |
We plan to share data under reasonable request
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D010024 | Osteoporosis |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Usual care group | Other | Participants randomly assigned to the usual care group will receive normal outpatient care, including physical rehabilitation when needed. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mortality | The endpoint will be incidence of this event | T2 1month T3 3 months T4 6 months T5 12 months |
| Admission and readmission to hospital | The endpoint will be incidence of this event | T2 1month T3 3 months T4 6 months T5 12 months |
| New fractures | The endpoint will be incidence of this event | T2 1month T3 3 months T4 6 months T5 12 months |
| D007869 |
| Leg Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |