Cognicise Training for Seniors for Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Maximal Oxygen Uptake (VO₂max)
研究概览
简要总结
The goal of this clinical trial is to assess the impact of two 8-week motor-cognitive exercise programs - Cognicise and yoga - on psychological, respiratory, cardiovascular, postural, and biochemical health in elderly women.
The main objectives are to evaluate whether these programs:
Improve psychological parameters such as mood, quality of life, depressive symptoms, and cognitive abilities;
Enhance respiratory function, including lung volumes and ventilation;
Influence cardiovascular parameters such as blood pressure and heart rate;
Improve chest mobility, physical fitness, and cardiorespiratory capacity;
Induce favorable changes in selected blood biomarkers, including neurotrophic factors, hormones, glucose, lipids, and blood morphology;
Improve postural stability, as assessed through posturographic analysis.
The study compares the effects of yoga and Cognicise to a control group that does not receive any intervention.
Participants in the yoga and Cognicise groups will take part in supervised sessions twice a week for 8 weeks (each session lasting 45 minutes).
Participants from all three groups (yoga, Cognicise, and control) will undergo pre- and post-intervention assessments, including:
Psychological questionnaires;
Spirometry and cardiorespiratory tests;
Blood pressure and heart rate measurements;
Chest mobility and physical fitness tests;
Posturographic assessment of postural control during quiet standing with eyes open and closed;
Laboratory blood tests (including BDNF, GDNF, 25(OH)D, TSH, testosterone, cortisol, insulin, glucose, lipid profile, and complete blood count with differential).
The aim is to determine whether structured motor-cognitive training leads to measurable health benefits compared to no intervention.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged over 65 years; Community-dwelling; Score of at least 7 points on the Abbreviated Mental Test Score (AMTS).
排除标准
- •(presence of at least one of the following):
- •Locomotor system disorders preventing independent movement; Morbid obesity; Active or stable cancer (ongoing radiation or chemotherapy); Liver disease with ALT > 3× upper limit of normal; Chronic kidney disease (eGFR < 30 mL/min/1.73 m²); Acute inflammation (CRP > 5 mg/dL); Unstable ischemic heart disease; History of ischemic or hemorrhagic stroke within the last 6 months; History of STEMI with drug-eluting stent implantation; NSTEMI within the past 12 months; Inherited metabolic disorders (e.g., phenylketonuria, galactosemia); Autoimmune diseases (e.g., acute thyroiditis, celiac disease, systemic connective tissue disease, hemolytic anemia, vitiligo, Addison's disease, hyperbilirubinemia); Non-specific enteritis (e.g., Crohn's disease, ulcerative colitis); Psychological disorders; Current antibiotic therapy; Current steroid therapy.
研究组 & 干预措施
Yoga Group
Participants in this group completed 16 yoga sessions over 8 weeks. Sessions were conducted twice a week and lasted 60 minutes each. Each session included a warm-up (15 minutes), a main part (30 minutes), and relaxation exercises (15 minutes). The practice focused on movements for the upper and lower limbs and the torso, especially the lumbar spine, pelvis, and hips. The final 10 minutes of each session were dedicated to achieving a deep relaxation state.
干预措施: Yoga Training (Behavioral)
Cognicise Group
Participants in this group completed 16 Cognicise training sessions over 8 weeks. Sessions were held twice a week and lasted 60 minutes. Each session followed a dual-task format combining motor and cognitive elements. Participants performed basic physical exercises while responding to live piano music and visual color cues. They also completed simple language tasks (e.g., spelling words backwards, naming items in categories) and arithmetic tasks. The session structure included a 15-minute warm-up, 30 minutes of cognitive-motor training, and 15 minutes of relaxation and breathing exercises.
干预措施: Cognicise Training (Behavioral)
Control Group
Participants in the control group did not participate in any structured physical or cognitive training during the 8-week intervention period. They were instructed to maintain their usual daily routines and not to begin any new exercise or therapy programs. Baseline and post-intervention assessments were conducted at the same time points as in the intervention groups.
结局指标
主要结局
Maximal Oxygen Uptake (VO₂max)
时间窗: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Predicted VO₂max estimated using a modified Åstrand-Ryhming protocol on a cycle ergometer. Higher values indicate better cardiovascular fitness. Units: milliliters per kilogram per minute (mL/kg/min)
Geriatric Depression Scale (GDS)
时间窗: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
GDS-15 (15 items). Scores range from 0 to 15; higher scores indicate more severe depressive symptoms. Units: score (0-15; higher = worse outcome)
Brain-Derived Neurotrophic Factor (BDNF)
时间窗: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Serum concentration of BDNF measured in fasting blood samples collected in the morning. Units: ng/mL.
Maximal Oxygen Uptake (VO₂max)
时间窗: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Predicted VO₂max estimated using a modified Åstrand-Ryhming protocol on a cycle ergometer. Higher values indicate better cardiovascular fitness. Units: milliliters per kilogram per minute (mL/kg/min)
Geriatric Depression Scale (GDS)
时间窗: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
GDS-15 (15 items). Scores range from 0 to 15; higher scores indicate more severe depressive symptoms. Units: score (0-15; higher = worse outcome)
Brain-Derived Neurotrophic Factor (BDNF)
时间窗: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Serum concentration of BDNF measured in fasting blood samples collected in the morning. Units: ng/mL.
次要结局
- Insulin (INS)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Testosterone to Cortisol Ratio (T/C)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Glial Cell Line-Derived Neurotrophic Factor (GDNF)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Irisin (IRS)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Stroop Test - Number of Errors(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Fat Mass(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Muscle Mass(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Visceral Fat(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Chest Expansion(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Vital Capacity - Percentage of Predicted(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Minute Ventilation (VE)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Tidal Volume (TV)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Respiratory Rate (RR)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- FEV1/FVC Ratio(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- HDL Cholesterol (HDL)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- LDL Cholesterol (LDL)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Glucose (GLU)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Insulin (INS)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Cortisol (COR)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Testosterone (TES)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Posturography - Displacements of Center of Pressure - Path Length:(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Rosenberg Self-Esteem Scale(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Beck Depression Inventory (BDI-II)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Stroop Test - Completion Time(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Maximal Expiratory Flow (MEF75, MEF50, MEF25)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Heart Rate (HR)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Systolic Blood Pressure (SBP)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Diastolic Blood Pressure (DBP)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Borg Rating of Perceived Exertion (RPE)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- White Blood Cells (WBC)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Red Blood Cells (RBC)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Hemoglobin (HGB)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Hematocrit (HCT)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Red Cell Distribution Width (RDW-CV)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Platelets (PLT)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Total Cholesterol (TC)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Posturography - Displacements of Center of Pressure - the total area enclosed by the COP trajectory(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Center of Pressure Path Length to its Area enclosed ratio(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Displacements of Center of Pressure - average Speed(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Displacements of Center of Pressure - average x-axis speed(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Displacements of Center of Pressure - average y-axis speed(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Glucose (GLU)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Diastolic Blood Pressure (DBP)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Chest Expansion(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Vital Capacity - Percentage of Predicted(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Triglycerides (TG)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Thyroid Stimulating Hormone (TSH)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Muscle Mass(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Visceral Fat(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Respiratory Rate (RR)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Rosenberg Self-Esteem Scale(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Maximal Expiratory Flow (MEF75, MEF50, MEF25)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Heart Rate (HR)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Systolic Blood Pressure (SBP)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Beck Depression Inventory (BDI-II)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Stroop Test - Completion Time(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Stroop Test - Number of Errors(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Fat Mass(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Minute Ventilation (VE)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Tidal Volume (TV)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Posturography - Displacements of Center of Pressure - Path Length:(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Posturography - Displacements of Center of Pressure - average Speed(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Body Mass Index (BMI)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- FEV1/FVC Ratio(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Hemoglobin (HGB)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Hematocrit (HCT)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Platelets (PLT)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Testosterone (TES)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Borg Rating of Perceived Exertion (RPE)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Red Blood Cells (RBC)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Total Cholesterol (TC)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- HDL Cholesterol (HDL)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- LDL Cholesterol (LDL)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Cortisol (COR)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Glial Cell Line-Derived Neurotrophic Factor (GDNF)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- White Blood Cells (WBC)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Red Cell Distribution Width (RDW-CV)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Testosterone to Cortisol Ratio (T/C)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Irisin (IRS)(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program))
- Posturography - Displacements of Center of Pressure - the total area enclosed by the COP trajectory(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Center of Pressure Path Length to its Area enclosed ratio(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Displacements of Center of Pressure - average y-axis speed(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)
- Posturography - Displacements of Center of Pressure - average x-axis speed(Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).)