About this trial
Background: Immunosenescence is an age-related decline in immune function, associated with chronic low-grade inflammation, increased morbidity, and functional impairment in older adults. Aerobic exercise has been proposed as an effective non-pharmacological strategy to counteract these alterations; however, evidence from randomized-controlled trials (RCTs), particularly in institutionalized elderly populations, remains scarce and methodologically limited.
Objective: This study protocol aims to investigate the effects of short- and medium-term aerobic exercise programs on immunosenescence in institutionalized older adults, as well as to analyze the impact of a detraining period and a subsequent reintervention.
Methods: A stratified RCT will be conducted with institutionalized adults aged ≥60 years, randomly allocated to an aerobic exercise group or a control group. The intervention consists of a supervised 12-week moderate-intensity aerobic exercise program (three sessions/week), followed by a 4-week detraining period and a 4-week reintervention. Assessments will be performed at five time points. Primary outcomes include immunological and analytical parameters assessed by spectral flow cytometry and multiplex cytokine analysis. Secondary outcomes include anthropometry, functional capacity, hemodynamic parameters, heart rate variability, and psychological indicators.
Expected Results: Aerobic exercise is expected to induce favorable immunological adaptations, partially reverse immunosenescence, and improve functional and psychosocial outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Aerobic exercise program
BehavioralSupervised moderate-intensity aerobic exercise program based on ACSM and WHO recommendations. Sessions will be delivered 3 times per week for 60 minutes, fully supervised by a certified exercise professional. Each session includes: (1) 5-10 min warm-up (joint mobility and light walking), (2) 30-50 min continuous aerobic exercise (primarily walking) targeting large muscle groups at 50-70% HRmax (Borg RPE 5-7), and (3) 5-10 min active recovery and static stretching. Intensity and progression will follow ACSM guidance, starting at light-to-moderate intensity and increasing continuous aerobic duration by \~5 min/week during the first 4 weeks, with subsequent individualized adjustments according to participants' adaptations. Adherence will be tracked via attendance logs, with ≥80% session attendance required for adequate compliance. Safety will be ensured through continuous monitoring for adverse events (e.g., chest pain, palpitations, abnormal dyspnea) with immediate session interruption an
Treatment groups
Trial outcomes
Primary outcomes
Sodium
Serum sodium concentration measured from peripheral blood samples. Unit of measure: mmol/L
Potassium
Serum potassium concentration measured from peripheral blood samples. Unit of measure: mmol/L
Chloride
Serum chloride concentration measured from peripheral blood samples. Unit of measure: mmol/L
Calcium
Total serum calcium concentration measured from peripheral blood samples. Unit of measure: mg/dL
Secondary outcomes
Height
Height measured using a portable stadiometer. Unit of measure: m
Weight
Body weight measured using a portable scale. Unit of measure: kg
Body mass index (BMI)
Body mass index calculated from height and body weight. Unit of measure: kg/m²
Visceral fat
Visceral fat measured using a portable scale. Unit of measure: score
Locations
Sponsors and contacts
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