Aging, Biomarkers / Blood, Cellular Senescence, Exercise, Frailty
Conditions
Keywords
Centenarians, Healthy aging, Senescence, Longevity, Personalized medicine, Preventive medicine, Omics technologies (genomics, proteomics, metabolomics), Artificial intelligence in healthcare, Exercise
Brief summary
This study aims to evaluate the effects of a home intervention of individualized multicomponent physical exercise program (including strength, balance, flexibility, and mobility training) on functional health, physical capacity, and biological markers in centenarians. The intervention includes periodic monitoring and individualized exercise progression every three weeks.
Detailed description
The BIOANCIENT\_EX study is a randomized clinical trial designed to assess the impact of an individualized structured physical exercise program in an elderly population. The intervention includes exercises designed to enhance the functional capacity and independence of centenarians. The strength training aims to target large muscle groups, alongside static and dynamic balance training, joint mobility, and aerobic capacity exercises. The control group will maintain their habitual routine. Participants are continuously monitored through regular follow-up using phone calls, video calls, or home visits when necessary. It is recommended that exercise sessions be performed in the company of a family member or caregiver. Additionally, audiovisual materials will be made available to facilitate the execution of the exercises. Exercise intensity and complexity are adjusted every three weeks based on participant performance and safety.
Interventions
OTHERExercise
Participants in the intervention group will take part in an individualized multicomponent physical training program including exercises targeting strength, balance, and aerobic capacity, adapted to older adults and conducted following established safety guidelines.
Sponsors
Fundacion Miguel Servet
Government of Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized Controlled Trial (RCT)
Eligibility
Sex/Gender
ALL
Age
100 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals aged ≥ 100 years; * Residents of Navarre.; * Barthel Index score ≥ 60, capable of standing and performing transfers independently or with minimal assistance; * Stable clinical condition; * Ability to follow simple instructions; * Signed informed consent (by the participant or legal representative).
Exclusion criteria
* Acute illness or unstable chronic condition, clinical decompensation within the last month: hemodynamic instability, acute pathology, hospitalization; * Severe cardiovascular or respiratory pathology that contraindicates exercise; * Severe cognitive impairment preventing participation; * Recent fracture or major surgery (\< 3 months). * Individuals in an end-of-life situation, defined as a clinical state of irreversible decline with a life expectancy of less than weeks or months, according to medical criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical function assessed by Short Physical Performance Battery (SPPB) | Baseline and 12-week follow-up | Physical Function: Assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait velocity, and leg strength as a single score on a 0 (worst) to 12 (best scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life index score assessed by the EQ-5D-5L | Baseline and 12-week follow-up | The EQ VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better health status. The EQ-5D-5L descriptive system is a standardized instrument for measuring health-related quality of life. It comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. This descriptive system is converted into a single utility index score using a country-specific value set. Index scores typically range from less than 0 (where 0 represents death and negative values represent states worse than death) to 1 (representing perfect health). Higher scores indicate better health states. |
| Patient self-rated health status assessed by the EQ-5D-5L VAS | Baseline and 12-week follow-up | The EQ Visual Analogue Scale (EQ VAS) is a component of the EQ-5D-5L questionnaire that records the respondent's self-rated health on a vertical visual analogue scale. Scores range from 0 to 100, where 0 represents 'the worst health you can imagine' and 100 represents 'the best health you can imagine'. Higher scores indicate a better self-perceived health status. |
| Functional status measured with Barthel Index | Baseline and 12-week follow-up | Barthel Index of independence during activities of daily living (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence). |
| Cognitive Function assessed with Mini Mental State Examination (MMSE) | Baseline and 12-week follow-up | Cognitive Function assessed with Mini-Mental State Examination (MMSE) is a 30-point tool designed to assess global cognitive function and screen for cognitive impairment, particularly in older adults. It evaluates several core areas of cognitive functioning, with higher scores indicating better cognitive performance, i.e. 30 (best) and 0 (worst). The 11 tasks in the MMSE are generally categorized into the following areas of cognitive functioning: Orientation (10 points), Registration (3 points), Attention and Calculation (5 points); Recall (3 points): .Language and Praxis (9 points). |
| Hand Grip Strength | Baseline and 12-week follow-up | Muscle Strength assessed by handgrip strength using a dynamometer (Takey Physical Fitness Test) measured in kilograms. The minimum recorded measurement is 5 kg and the maximum is 100 kg. Grip strength is a powerful biomarker of aging and overall muscle strength. Low handgrip strength is associated with increased risks of cardiovascular disease, stroke, type 2 diabetes, and premature mortality. |
| Lower Limb Muscle Strength | Baseline and 12-week follow-up | Lower Limb Muscle Strength. Isometric lower limb muscle strength assessed using a Hoggan dynamometer. Knee extensor strength and hip flexor strength will be measured with participants in a standardized seated position, starting with the knee flexed (90º). Force will be recorded in kilograms (kg). Higher values indicate greater muscle strength. |
| Cognitive Function (Clock Drawing Test) | Baseline and 12-week follow-up | Cognitive function assessed using the Clock Drawing Test (CDT), in which participants are asked to draw a clock showing a specified time. The test evaluates executive function, visuospatial ability, and planning. Performance will be scored using a standardized scoring system, with higher scores indicating better cognitive performance. Results range from 0 (worst) to 10 (best). |
| Nutritional Status assessed using the Mini Nutritional Assessment - Short Form (MNA-SF) | Baseline and 12-week follow-up | Nutritional Status assessed using the Mini Nutritional Assessment - Short Form (MNA-SF), a rapid, validated 6-item screening tool designed to identify older adults (aged 65+) who are malnourished or at risk of malnutrition. It is widely used in hospitals, nursing homes, and community settings to initiate early nutritional interventions. Scoring from 14 points (better) and 0 points (worse):12-14 points: Normal nutritional status; 8-11 points: At risk of malnutrition and; 0-7 points: Malnourished. |
| Sarcopenia Risk (SARC-F questionnaire) | Baseline and 12-week follow-up | Risk of sarcopenia assessed using the SARC-F questionnaire, a five-item self-reported screening tool evaluating strength, assistance in walking, rising from a chair, climbing stairs, and falls. Total scores range from 0 to 10, with higher scores indicating greater risk of sarcopenia and functional decline. |
| Depressive Symptoms (Geriatric Depression Scale - GDS-15) | Baseline and 12-week follow-up | Depressive symptoms assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-reported questionnaire designed to screen for depression in older adults. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms. Scores of 0-4 are considered normal, 5-9 suggest mild depression, and 10-15 indicate moderate to severe depression. |
| Mobility and Functional Performance (Timed Up and Go Test - TUG) | Baseline and 12-week follow-up | Mobility and functional performance assessed using the Timed Up and Go (TUG) test. Participants are instructed to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time to complete the task is recorded in seconds. Lower times indicate better mobility and functional performance. Times greater than or equal to 12 seconds are commonly associated with increased risk of falls in older adults. |
| Bioimpedance Analysis (BIVA - Bioelectrical Impedance Vector Analysis) | Baseline and 12-week follow-up | Bioimpedance Analysis (BIVA - Bioelectrical Impedance Vector Analysis): Whole-body bioelectrical impedance vector analysis (BIVA) assessed using a phase-sensitive bioimpedance device (e.g., BIVA Pro). Raw bioelectrical parameters including resistance (R, ohms) and reactance (Xc, ohms) will be measured at 50 kHz and normalized by height (R/H, Xc/H). BIVA provides a qualitative and semi-quantitative assessment of body composition, including hydration status and body cell mass, without relying on predictive equations. Vector displacement patterns will be interpreted as follows: Vector shortening (↓R/H, ↓Xc/H): fluid overload or increased hydration Vector lengthening (↑R/H, ↑Xc/H): dehydration or reduced fluid content Increased phase angle: better cellular integrity and nutritional status Decreased phase angle: impaired cellular health or frailty. |
| Proteomic Biomarkers | Baseline (single assessment) | Proteomic biomarkers assessed through the identification and quantification of circulating proteins associated with aging and frailty using high-throughput proteomic techniques. Protein expression levels will be measured in biological samples (e.g., plasma or serum), and relative or absolute concentrations will be analyzed. |
| Falls (Number of falls over the past 12 months) | Baseline and 12-week follow-up | Total number of unintentional falls experienced by the participant during the 12 months prior to the assessment. A fall is defined as an unexpected event in which the participant comes to rest on the ground, floor, or lower level. Data will be collected via self-report calendar. |
| Fear of Falling | Baseline and 12-week follow-up | Assessment of the participant's fear of falling, categorized as a dichotomous outcome (Yes or No). Participants are asked the single standard question: "Are you afraid of falling?". A response of "Yes" indicates the presence of fear, while "No" indicates its absence. |
| Pain Intensity | Baseline and 12-week follow-up | Pain intensity will be assessed using a standard Visual Analog Scale (VAS). The scale consists of a 10 cm horizontal line, where the left endpoint (0) represents "no pain" and the right endpoint (10) represents "worst imaginable pain". Participants mark the point on the line that best represents their current pain level. Higher scores indicate greater pain severity. |
| Polypharmacy | Baseline and 12-week follow-up | Polypharmacy assessed as the concurrent use of multiple medications. The total number of regularly prescribed medications will be recorded for each participant. Polypharmacy will be defined as the use of five or more medications (≥5). The outcome will be analyzed both as a continuous variable (number of medications) and as a categorical variable (presence vs absence of polypharmacy). Higher values indicate greater medication burden. Prior and Concomitant Medication History; Baseline assessment of chronic pharmacological exposure. Participants report lifetime use (lasting \>1 year) of 27 key drug classes (Yes/No), including cardiovascular, endocrine, respiratory, analgesic, anti-infective, neuropsychiatric, gastrointestinal, bone, and immune therapies. Long-term historical medications are also captured via open text. Reported as counts and percentages. |
| Comorbidity Burden | Baseline | Comorbidity burden assessed using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G), which evaluates the severity of chronic medical conditions across 14 organ systems. Each system is rated on a 5-point scale (0 = no problem to 4 = extremely severe impairment). The total score ranges from 0 to 56, with higher scores indicating greater comorbidity burden. |
| Comorbidity Profile and Disease Burden via ICD-10 Classification | Baseline | Evaluation of participant medical history and current health status classified according to the International Classification of Diseases, 10th Revision (ICD-10). Diagnoses will be extracted from electronic medical records or clinical interviews and mapped to their corresponding ICD-10 codes. The analysis will focus on the total number of coexisting chronic conditions per participant (disease burden) and the prevalence of major ICD-10 diagnostic chapters (e.g., cardiovascular, metabolic, musculoskeletal diseases). |
| Plasma RNA sequencing profile | Baseline and 12-week follow-up | Assessment of the RNA profile isolated from total plasma samples using next-generation sequencing (NGS) to evaluate changes over time. |
| Extracellular vesicle RNA sequencing profile | Baseline and 12-week follow-up | Assessment of the RNA profile isolated from purified extracellular vesicles using next-generation sequencing (NGS) to evaluate changes over time. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORNicolas Martínez Velilla, MD and PhD
Navarrabiomed, Hospital Universitario de Navarra, IdisNa, Universidad Pública de Navarra
STUDY_DIRECTORChenhui Chen, MD
Navarrabiomed, Hospital Universitario de Navarra, IdisNa, Universidad Pública de Navarra
STUDY_CHAIREnrique Santamaría, PhD
Navarrabiomed, Hospital Universitario de Navarra, IdisNa, Universidad Pública de Navarra
Outcome results
None listed