The Impact of Aerobic Exercise Program on Immunosenescence Institutionalized Older Adults

NCT07476911 | Not Yet Recruiting

• 1 other identifier: IPCB-ESE
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Immunosenescence; Aging

Keywords

Aerobic exercise; Elderly; Aging; Institutionalized; Immune system; Immunosenescence

Outcome Measures

Primary Outcomes (40)

• Sodium

  Serum sodium concentration measured from peripheral blood samples. Unit of measure: mmol/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Potassium

  Serum potassium concentration measured from peripheral blood samples. Unit of measure: mmol/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Chloride

  Serum chloride concentration measured from peripheral blood samples. Unit of measure: mmol/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Calcium

  Total serum calcium concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Phosphorus

  Serum phosphorus concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Magnesium

  Serum magnesium concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Aspartate aminotransferase (AST)

  Serum AST activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Alanine aminotransferase (ALT)

  Serum ALT activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Gamma-glutamyl transferase (GGT)

  Serum gamma-glutamyl transferase activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Total bilirubin

  Total bilirubin concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Direct bilirubin

  Direct bilirubin concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Alkaline phosphatase

  Serum alkaline phosphatase activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Lactate dehydrogenase (LDH)

  Serum lactate dehydrogenase activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Total cholesterol

  Total cholesterol concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• HDL cholesterol

  High-density lipoprotein cholesterol concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• LDL cholesterol

  Low-density lipoprotein cholesterol concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Triglycerides

  Serum triglyceride concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Amylase

  Serum amylase activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Urea

  Serum urea concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Creatinine

  Serum creatinine concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Uric acid

  Serum uric acid concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Total proteins

  Total serum protein concentration measured from peripheral blood samples. Unit of measure: g/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Albumin

  Serum albumin concentration measured from peripheral blood samples. Unit of measure: g/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Glucose

  Fasting blood glucose concentration measured from peripheral blood samples. Unit of measure: mg/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Glycated haemoglobin (HbA1c)

  Glycated haemoglobin measured from peripheral blood samples. Unit of measure: %

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Creatine kinase (CK)

  Serum creatine kinase activity measured from peripheral blood samples. Unit of measure: U/L

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Red blood cell count

  Red blood cell count measured from peripheral blood samples. Unit of measure: 10\^6/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Haemoglobin

  Haemoglobin concentration measured from peripheral blood samples. Unit of measure: g/dL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Haematocrit

  Haematocrit measured from peripheral blood samples. Unit of measure: %

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• White blood cell count

  White blood cell count measured from peripheral blood samples. Unit of measure: 10\^3/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Platelet count

  Platelet count measured from peripheral blood samples. Unit of measure: 10\^3/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Natural killer (NK) cell count

  Natural killer cell count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL and %

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• CD3+ T cell count

  CD3+ T lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• CD4+ T cell count

  CD4+ T lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• CD8+ T cell count

  CD8+ T lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• B cell count

  B lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Interleukin-6 (IL-6)

  Plasma IL-6 concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Tumour necrosis factor-alpha (TNF-α)

  Plasma TNF-α concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Interleukin-10 (IL-10)

  Plasma IL-10 concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Interleukin-1 beta (IL-1β)

  Plasma IL-1β concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

Secondary Outcomes (24)

• Height

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Weight

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Body mass index (BMI)

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Visceral fat

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

• Body fat percentage

  Baseline (T0); After 6 weeks of intervention (T6); After 12 weeks of intervention (T12); After 4 week detraining (T16); After 4 weeks re-intervention (T20)

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

Group of participants who will take part in a supervised aerobic exercise program.

Behavioral: Aerobic exercise program

Control Group

NO INTERVENTION

A group of participants who will maintain their usual routines, without any systematic practice of physical exercise.

Interventions

Aerobic exercise program BEHAVIORAL

Supervised 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

Aerobic Exercise Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be aged 60 years or older and institutionalized. Studying institutionalised older adults ensures greater uniformity in diet, daily routines, behaviours, and environmental exposures, thereby minimising the impact of external factors other than the exercise intervention.

You may not qualify if:

• Participants will be excluded if they have acute conditions that may affect their immune or inflammatory responses. These conditions include recent trauma or surgery (within the previous six months), recent blood transfusions (within the previous month), acute infections (such as respiratory, gastrointestinal, or urinary infections), recent vaccinations, and the use of medications that may interfere with immune responses (such as immunomodulators, systemic corticosteroids, methotrexate, and biologics).

Sponsors & Collaborators

• Instituto Politécnico de Castelo Branco: lead

Central Study Contacts

Carlos M Farinha, Carlos Farinha, Dr.

CONTACT

+351924167929; cmnfarinha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 17, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03