The Impact of Aerobic Exercise Program on Immunosenescence in Institutionalized Older Adults: a Study Protocol for Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Sodium
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Aerobic Exercise Group
Group of participants who will take part in a supervised aerobic exercise program.
干预措施: Aerobic exercise program (Behavioral)
Control Group
A group of participants who will maintain their usual routines, without any systematic practice of physical exercise.
结局指标
主要结局
Sodium
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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))
- Muscle mass 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))
- Waist circumference(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(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(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(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(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(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(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(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(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)(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)(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)(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)(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(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(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(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(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(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))
研究者
Carlos Farinha
Principal Researcher
Instituto Politécnico de Castelo Branco