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Not yet recruiting NCT07476911

The Impact of Aerobic Exercise Program on Immunosenescence Institutionalized Older Adults

No phase Interventional Immunosenescence Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise program.
Who it may be relevant to
Registry conditions: Immunosenescence, Aging. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Aerobic Exercise Program on Immunosenescence in Institutionalized Older Adults: a Study Protocol for Randomized Controlled Trials

Overview

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.

Detailed description

This investigation will be based on a stratified randomized intervention. Participants will initially be stratified according to clinical conditions. Within each stratum, a 1:1 randomization will be performed to the experimental group (AERG) and control group (CG) using software SPSS. The randomization sequence will be generated using variable-size permuted blocks to ensure a balance in the number of participants in each group and reduce the risk of allocation predictability. Randomization will be performed by a researcher external to the data collection and intervention implementation process. The randomization will be stored in an encrypted file until the start of the intervention, ensuring allocation concealment.

An aerobic exercise program (12 weeks) will be implemented, followed by a detraining period (4 weeks) and the implementation of a second intervention (4 weeks). Primary outcomes include analysis of analytical parameters and cellular assessment. Secondary outcomes include anthropometric analysis, functional capacity, hemodynamic parameters, and psychological parameters. All participants will be assessed at five distinct time points, as shown in Figure 1: before the intervention (T0), at 6 weeks (T6) and at 12 weeks (T12) of intervention, after the detraining period (T16), and after the second intervention (T20).

Interventions

  • Behavioral Aerobic exercise program
    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

Primary outcome measures

  • Sodium [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 outcome measures (12)
  • Height [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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)]
  • Muscle mass percentage [Time frame: 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)]
  • Waist circumference [Time frame: 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)]
  • Arm circumference [Time frame: 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)]
  • Leg circumference [Time frame: 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)]
  • 30-Second Chair Stand Test [Time frame: 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)]
  • 30-Second Arm Curl Test [Time frame: 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)]
  • 6-Minute Walk Test [Time frame: 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)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07476911 · IPCB-ESE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗