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| Name | Class |
|---|---|
| Nestle Health Science | INDUSTRY |
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The aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby improving functional and cognitive capacity.
To achieve this objective, we will conduct a randomized clinical trial in which patients are randomly assigned to either the control group, which does not perform the physical training, or the intervention group, which participates in the multicomponent physical training program.
The main objective of the present study is to evaluate the differences in the impact of an intervention based solely on physical exercise on the functionality of hospitalized older patients, in an Acute Geriatric Unit, who are malnourished or at risk of malnutrition.
As secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants included in this group will perform physical exercise |
|
| Control | Active Comparator | Participants in this group will receive attention from a physiotherapist if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Other | Progressive, supervised multicomponent physical exercise program, including aerobic resistance, strength, and balance training. Strength training for lower limbs (leg press and knee extension) and upper limbs (seated chest press) will be adapted to each individual's functional capacity. |
| Measure | Description | Time Frame |
|---|---|---|
| Function | SPPB - Short Physical Performance Battery | Through study completion, an average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometrical Measurements | Bioimpedance: PHASE ANGLE (PhA), Fat-Free Mass (FFM) and Muscle Mass (MM). Conventional and vectorial bioelectrical impedance analysis with a single-frequency bioelectrical impedance analyzer at 50 kHz (BIA 101 RJL, Akern Bioresearch, Florence, Italy) | Through study completion, an average of 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenhui Chen, Doctor | Contact | +34 664426191 | chenhuichen253@gmail.com | |
| Nicolás Martínez Velilla, Doctor, MD, PhD | Contact | 00 34 848422222 | nicolas.martinez.velilla@navarra.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Usual Care | Other |
|
|
| Dietary intake |
Semi-quantitative questionnaire and a daily appetite assessment |
| Through study completion, an average of 4 days |
| Number and type of infectious complications | Through study completion, an average of 4 days |
| Nutritional status biomarkers | In blood: proteins, prealbumin, albumin, transferrin, lymphocytes, 25-hydroxyvitamin D, C-reactive protein. | Through study completion, an average of 4 days, and 30 days post-discharge |
| Functional status | Barthel Index, Lawton Index | Through study completion, an average of 4 days, and 30 days post-discharge |
| Frailty status | Linda Fried's Frailty Scale, from 0 to 5 (0 robust; 1,2 pre-frail; 3 to 5 frail). | Baseline |
| Strength of upper and lower limbs | Leg press, chest press, knee extension, and handgrip strength | Through study completion, an average of 4 days |
| Cognitive status | Mini-Mental State Examination, 4AT | Through study completion, an average of 4 days |
| Affective status | Yesavage's 15-item Geriatric Depression Scale (GDS-15) | Through study completion, an average of 4 days |
| Quality of life of participants | EuroQoL-5D-3L | Through study completion, an average of 4 days |
| Adverse effects possibly attributed to the intervention | Through study completion, an average of 4 days |