ImmunosenescenceNCT07476911
The Impact of Aerobic Exercise Program on Immunosenescence Institutionalized Older Adults
A study testing Aerobic exercise program in people with Immunosenescence and Aging, run by Instituto Politécnico de Castelo Branco.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence, Aging
- What is being tested?
- Aerobic exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Aerobic Exercise Program on Immunosenescence in Institutionalized Older Adults: a Study Protocol for Randomized Controlled Trials
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.
Read more
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.
Read the 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).
- Conditions
- Immunosenescence, Aging
- Being tested
- Aerobic exercise program
- Keywords
- Aerobic exercise, Elderly, Aging, Institutionalized, Immune system, Immunosenescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | Group of participants who will take part in a supervised aerobic exercise program. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium
Serum sodium concentration measured from peripheral blood samples. Unit of measure: mmol/L
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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: %
Measured: 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
Measured: 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
Measured: 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
Measured: 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: %
Measured: 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
Measured: 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
Measured: 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 %
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Height measured using a portable stadiometer. Unit of measure: m
Measured: 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
Body weight measured using a portable scale. Unit of measure: kg
Measured: 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)
Body mass index calculated from height and body weight. Unit of measure: kg/m²
Measured: 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
Visceral fat measured using a portable scale. Unit of measure: score
Measured: 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
Body fat percentage measured using a portable scale. Unit of measure: %
Measured: 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
Muscle mass percentage measured using a portable scale. Unit of measure: %
Measured: 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
Waist circumference measured using a retractable fiberglass tape measure. Unit of measure: cm
Measured: 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
Arm circumference measured using a retractable fiberglass tape measure. Unit of measure: cm
Measured: 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
Leg circumference measured using a retractable fiberglass tape measure. Unit of measure: cm
Measured: 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
Number of full stands completed in 30 seconds from a seated position, used to assess lower body strength.
Unit of measure: repetitions
Measured: 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
Number of arm curls completed in 30 seconds, used to assess upper body strength.
Unit of measure: repetitions
Measured: 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
Distance covered in 6 minutes while walking, used to assess cardiorespiratory endurance.
Unit of measure: meters
Measured: 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)
Chair Sit-and-Reach Test
Distance between the extended fingers and the tip of the toe in the seated sit-and-reach position, used to assess lower body flexibility.
Unit of measure: cm
Measured: 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)
Back Scratch Test
Distance between the middle fingers when reaching one hand over the shoulder and the other up the middle of the back, used to assess upper body flexibility.
Unit of measure: cm
Measured: 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)
8-Foot Up-and-Go Test
Time taken to rise from a chair, walk 8 feet, turn, and return to the seated position, used to assess agility and dynamic balance.
Unit of measure: seconds
Measured: 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)
Heart rate (HR)
Resting heart rate measured using an automatic digital sphygmomanometer. The average of three measurements will be recorded.
Unit of measure: beats per minute (bpm)
Measured: 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)
Systolic blood pressure (SBP)
Resting systolic blood pressure measured using an automatic digital sphygmomanometer. The average of three measurements will be recorded.
Unit of measure: mmHg
Measured: 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)
Diastolic blood pressure (DBP)
Resting diastolic blood pressure measured using an automatic digital sphygmomanometer. The average of three measurements will be recorded.
Unit of measure: mmHg
Measured: 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)
Heart rate variability (HRV)
Heart rate variability assessed during a 10-minute resting test using a heart rate monitor in a calm, quiet, and dimly lit environment. Data will be transferred from the Polar Flow Web Service for analysis.
Unit of measure: ms
Measured: 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)
Perceived stress
Perceived stress assessed using the Perceived Stress Scale (PSS). Unit of measure: score
Measured: 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)
General health status
Health-related quality of life assessed using the EuroQol (EQ-5D). Unit of measure: score
Measured: 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)
Life satisfaction
Satisfaction with life assessed using the Satisfaction With Life Scale (SWLS). Unit of measure: score
Measured: 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)
Positive affect
Positive affect assessed using the Positive and Negative Affect Schedule (PANAS).
Unit of measure: score
Measured: 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)
Negative affect
Negative affect assessed using the Positive and Negative Affect Schedule (PANAS).
Unit of measure: score
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Castelo Branco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Farinha, Instituto Politécnico de Castelo Branco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476911
- Sponsor's protocol ID
- IPCB-ESE
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aerobic Exercise Program on Immunosenescence in Institutionalized Older Adults: a Study Protocol for Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT07476911
- Acronym / sponsor ID
- IPCB-ESE
- Conditions
- Immunosenescence, Aging
- Keywords
- Aerobic exercise, Elderly, Aging, Institutionalized, Immune system, Immunosenescence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Politécnico de Castelo BrancoUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Behavioral: Aerobic exercise programGroup of participants who will take part in a supervised aerobic exercise program. |
| Control Group | No intervention | –A group of participants who will maintain their usual routines, without any systematic practice of physical exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise programSupervised 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 | Behavioural | Aerobic Exercise Group |
Primary outcome
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)
Serum sodium concentration measured from peripheral blood samples. Unit of measure: mmol/L
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)
Serum potassium concentration measured from peripheral blood samples. Unit of measure: mmol/L
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)
Serum chloride concentration measured from peripheral blood samples. Unit of measure: mmol/L
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)
Total serum calcium concentration measured from peripheral blood samples. Unit of measure: mg/dL
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)
Serum phosphorus concentration measured from peripheral blood samples. Unit of measure: mg/dL
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)
Serum magnesium concentration measured from peripheral blood samples. Unit of measure: mg/dL
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)
Serum AST activity measured from peripheral blood samples. Unit of measure: U/L
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)
Serum ALT activity measured from peripheral blood samples. Unit of measure: U/L
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)
Serum gamma-glutamyl transferase activity measured from peripheral blood samples. Unit of measure: U/L
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)
Total bilirubin concentration measured from peripheral blood samples. Unit of measure: mg/dL
Direct 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)
Direct bilirubin concentration measured from peripheral blood samples. Unit of measure: mg/dL
Alkaline phosphatase
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)
Serum alkaline phosphatase activity measured from peripheral blood samples. Unit of measure: U/L
Lactate dehydrogenase (LDH)
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)
Serum lactate dehydrogenase activity measured from peripheral blood samples. Unit of measure: U/L
Total cholesterol
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 cholesterol concentration measured from peripheral blood samples. Unit of measure: mg/dL
HDL cholesterol
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)
High-density lipoprotein cholesterol concentration measured from peripheral blood samples. Unit of measure: mg/dL
LDL cholesterol
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)
Low-density lipoprotein cholesterol concentration measured from peripheral blood samples. Unit of measure: mg/dL
Triglycerides
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)
Serum triglyceride concentration measured from peripheral blood samples. Unit of measure: mg/dL
Amylase
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)
Serum amylase activity measured from peripheral blood samples. Unit of measure: U/L
Urea
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)
Serum urea concentration measured from peripheral blood samples. Unit of measure: mg/dL
Creatinine
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)
Serum creatinine concentration measured from peripheral blood samples. Unit of measure: mg/dL
Uric acid
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)
Serum uric acid concentration measured from peripheral blood samples. Unit of measure: mg/dL
Total proteins
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 serum protein concentration measured from peripheral blood samples. Unit of measure: g/dL
Albumin
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)
Serum albumin concentration measured from peripheral blood samples. Unit of measure: g/dL
Glucose
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)
Fasting blood glucose concentration measured from peripheral blood samples. Unit of measure: mg/dL
Glycated haemoglobin (HbA1c)
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)
Glycated haemoglobin measured from peripheral blood samples. Unit of measure: %
Creatine kinase (CK)
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)
Serum creatine kinase activity measured from peripheral blood samples. Unit of measure: U/L
Red blood cell count
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)
Red blood cell count measured from peripheral blood samples. Unit of measure: 10^6/µL
Haemoglobin
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)
Haemoglobin concentration measured from peripheral blood samples. Unit of measure: g/dL
Haematocrit
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)
Haematocrit measured from peripheral blood samples. Unit of measure: %
White blood cell count
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)
White blood cell count measured from peripheral blood samples. Unit of measure: 10^3/µL
Platelet count
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)
Platelet count measured from peripheral blood samples. Unit of measure: 10^3/µL
Natural killer (NK) cell count
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)
Natural killer cell count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL and %
CD3+ T cell count
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)
CD3+ T lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL
CD4+ T cell count
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)
CD4+ T lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL
CD8+ T cell count
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)
CD8+ T lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL
B cell count
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)
B lymphocyte count measured by spectral flow cytometry from peripheral blood samples. Unit of measure: cells/µL
Interleukin-6 (IL-6)
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)
Plasma IL-6 concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL
Tumour necrosis factor-alpha (TNF-α)
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)
Plasma TNF-α concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL
Interleukin-10 (IL-10)
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)
Plasma IL-10 concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL
Interleukin-1 beta (IL-1β)
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)
Plasma IL-1β concentration measured using multiplex technology from peripheral blood samples. Unit of measure: pg/mL
24 secondary outcomes
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)
Chair Sit-and-Reach 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)
Back Scratch 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)
8-Foot Up-and-Go 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)
Heart rate (HR)
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)
Systolic blood pressure (SBP)
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)
Diastolic blood pressure (DBP)
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)
Heart rate variability (HRV)
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)
Perceived stress
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)
General health status
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)
Life satisfaction
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)
Positive affect
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)
Negative affect
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise program in people with Immunosenescence and Aging, run by Instituto Politécnico de Castelo Branco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos M Farinha, Carlos Farinha, Dr. (+351924167929, cmnfarinha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.