The Impact of Aerobic Exercise Program on Immunosenescence Institutionalized Older Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorInstituto Politécnico de Castelo Branco

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Aerobic Exercise GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Sodium

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

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)
2

Potassium

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

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)
3

Chloride

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

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)
4

Calcium

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

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 outcomes

1

Height

Height measured using a portable stadiometer. Unit of measure: m

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)
2

Weight

Body weight measured using a portable scale. Unit of measure: kg

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)
3

Body mass index (BMI)

Body mass index calculated from height and body weight. Unit of measure: kg/m²

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)
4

Visceral fat

Visceral fat measured using a portable scale. Unit of measure: score

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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