University Hospital of Navarra
Pamplona, Navarre, 31008, Spain
Location status: Recruiting
NCT Number: NCT07067697
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.
Interested in participating?
Request Info75 year and older
All sexes
Interventional
Not applicable
Pamplona, Navarre, 31008, Spain
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study completion, an average of 4 days
SPPB - Short Physical Performance Battery
Time frame: Through study completion, an average of 4 days
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)
Time frame: Through study completion, an average of 4 days
Semi-quantitative questionnaire and a daily appetite assessment
Time frame: Through study completion, an average of 4 days
Time frame: Through study completion, an average of 4 days, and 30 days post-discharge
In blood: proteins, prealbumin, albumin, transferrin, lymphocytes, 25-hydroxyvitamin D, C-reactive protein.
Time frame: Through study completion, an average of 4 days, and 30 days post-discharge
Barthel Index, Lawton Index
Time frame: Baseline
Linda Fried's Frailty Scale, from 0 to 5 (0 robust; 1,2 pre-frail; 3 to 5 frail).
Time frame: Through study completion, an average of 4 days
Leg press, chest press, knee extension, and handgrip strength
Time frame: Through study completion, an average of 4 days
Mini-Mental State Examination, 4AT
Time frame: Through study completion, an average of 4 days
Yesavage's 15-item Geriatric Depression Scale (GDS-15)
Time frame: Through study completion, an average of 4 days
EuroQoL-5D-3L
Time frame: Through study completion, an average of 4 days
Contact information is provided by the study sponsor or research team.
Chenhui Chen, Doctor
CONTACT
Nicolás Martínez Velilla, Doctor, MD, PhD
CONTACT
Fundacion Miguel Servet
Other
The Effect of Physical Exercise on the Physical Function of Hospitalized Older Adults Malnourished or at Risk of Malnourishment With Oral Nutritional Supplementation
Acronym: NUTPHYS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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