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Completed

NCT Number: NCT07098533

Cognicise Training for Seniors for Healthy Aging

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.

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Key information

Conditions

Depressive Symptom Behavior Behavioral Symptoms Blood Biomarkers Cardiopulmonary Cognitive Functions Depression Elderly (People Aged 65 or More) Fall Risk Motor Activity Physical Fitness Postmenopausal Women Postural Stability Quality of Life

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Physical Education

Poznan, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women aged over 65 years; Community-dwelling; Score of at least 7 points on the Abbreviated Mental Test Score (AMTS).

Exclusion criteria

(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.

Treatment and study plan

Cognicise Training

Behavioral

The Cognicise program included 16 sessions over 8 weeks (twice weekly, 60 minutes each). This dual-task training combined motor activities with cognitive exercises. During basic gymnastic movements, participants responded to real-time changes in live music and visual stimuli while also solving simple verbal and math tasks. Sessions were divided into 15 minutes of warm-up, 30 minutes of dual-task activity, and 15 minutes of breathing and relaxation exercises.

Yoga Training

Behavioral

The yoga intervention consisted of 16 instructor-led sessions over 8 weeks (twice weekly, 60 minutes each). Each session included a warm-up (15 minutes), a main phase (30 minutes) focused on exercises targeting the spine, pelvis, and hips, and a relaxation period (15 minutes), including 10 minutes of deep relaxation techniques.

Primary outcomes

  1. Maximal Oxygen Uptake (VO₂max)

    Time frame: 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)

  2. Geriatric Depression Scale (GDS)

    Time frame: 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)

  3. Brain-Derived Neurotrophic Factor (BDNF)

    Time frame: 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.

Secondary outcomes

  1. Rosenberg Self-Esteem Scale

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Stroop test10-item scale. Scores range from 0 to 30; higher scores indicate greater self-esteem. Units: score (0-30; higher = better outcome).

  2. Beck Depression Inventory (BDI-II)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    21-item inventory. Scores range from 0 to 63; higher scores indicate greater depressive symptoms. Units: score (0-63; higher = worse outcome).

  3. Stroop Test - Completion Time

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Time (in seconds) to complete the interference condition of the Stroop Test. Lower values indicate better executive functioning. Units: seconds (s).

  4. Stroop Test - Number of Errors

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Number of errors during the interference condition. Lower scores indicate better cognitive control. Units: count.

  5. Body Mass Index (BMI)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Calculated as body mass (kg) divided by height (m) squared. Units: kg/m².

  6. Fat Mass

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Body fat percentage measured using bioimpedance analysis. Units: %.

  7. Muscle Mass

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Skeletal muscle mass percentage via bioimpedance analysis. Units: %.

  8. Visceral Fat

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Visceral fat level assessed via bioimpedance analysis, expressed as an index score. Units: score.

  9. Chest Expansion

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Thoracic expansion measured with tape during maximum inspiration and expiration. Units: centimeters (cm).

  10. Vital Capacity - Percentage of Predicted

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Vital capacity expressed as a percentage of predicted value based on age, sex, and height. Units: %.

  11. Minute Ventilation (VE)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Volume of air exhaled per minute. Units: liters per minute (L/min).

  12. Tidal Volume (TV)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Volume of air exhaled in one breath. Units: milliliters (mL).

  13. Respiratory Rate (RR)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Number of breaths per minute during resting conditions. Units: breaths per minute (brpm).

  14. FEV1/FVC Ratio

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Ratio of forced expiratory volume in one second to forced vital capacity. Units: percentage (%).

  15. Maximal Expiratory Flow (MEF75, MEF50, MEF25)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Maximal flow at selected points of forced expiration, expressed as a percentage of predicted. Units: percentage (%).

  16. Heart Rate (HR)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Measured at rest using standard heart rate monitor. Units: beats per minute (bpm).

  17. Systolic Blood Pressure (SBP)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Measured in mmHg using standard sphygmomanometer. Units: millimeters of mercury (mmHg).

  18. Diastolic Blood Pressure (DBP)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Measured in mmHg using standard sphygmomanometer. Units: millimeters of mercury (mmHg).

  19. Borg Rating of Perceived Exertion (RPE)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Subjective perception of exertion using a 1-10 scale. Units: score (1-10).

  20. White Blood Cells (WBC)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Measured from fasting serum sample. Units: mg/dL.

  21. Red Blood Cells (RBC)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Total erythrocyte count. Units: 10¹²/L.

  22. Hemoglobin (HGB)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Hemoglobin concentration in blood. Units: g/dL.

  23. Hematocrit (HCT)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Proportion of blood volume occupied by red cells. Units: percentage (%).

  24. Red Cell Distribution Width (RDW-CV)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Coefficient of variation of red blood cell size distribution. Units: percentage (%).

  25. Platelets (PLT)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Platelet count. Units: 10⁹/L.

  26. Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Differential white blood cell count. Units: percentage (%).

  27. Total Cholesterol (TC)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Measured from fasting serum sample. Units: mg/dL.

  28. HDL Cholesterol (HDL)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    High-density lipoprotein cholesterol. Units: mg/dL.

  29. LDL Cholesterol (LDL)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Low-density lipoprotein cholesterol. Units: mg/dL.

  30. Triglycerides (TG)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Serum triglyceride concentration. Units: mg/dL.

  31. Glucose (GLU)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Fasting glucose concentration. Units: mg/dL.

  32. Thyroid Stimulating Hormone (TSH)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Serum TSH level. Units: μIU/mL.

  33. Insulin (INS)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Serum insulin concentration. Units: μIU/mL.

  34. Cortisol (COR)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Morning serum cortisol level. Units: µg/dL.

  35. Testosterone (TES)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Total serum testosterone concentration. Units: ng/mL.

  36. Testosterone to Cortisol Ratio (T/C)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Ratio of serum testosterone to cortisol. Units: unitless (arbitrary units).

  37. Glial Cell Line-Derived Neurotrophic Factor (GDNF)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Serum concentration of GDNF. Units: ng/mL.

  38. Irisin (IRS)

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Serum irisin concentration. Units: ng/mL.

  39. Posturography - Displacements of Center of Pressure - Path Length:

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)

    Total path length of center of pressure displacement during quiet standing. Units: mm.

  40. Posturography - Displacements of Center of Pressure - the total area enclosed by the COP trajectory

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).

    Assessment of postural stability during quiet standing for 30 seconds with eyes open and eyes closed. Measurement of the total area enclosed by the COP trajectory in square centimeters (cm²).

  41. Posturography - Center of Pressure Path Length to its Area enclosed ratio

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).

    Assessment of postural stability during quiet standing for 30 seconds with eyes open and eyes closed. Ratio of COP path length to the enclosed area (unitless).

  42. Posturography - Displacements of Center of Pressure - average Speed

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).

    Assessment of postural stability during quiet standing for 30 seconds with eyes open and eyes closed. Average speed of COP displacement measured in centimeters per second (cm/s).

  43. Posturography - Displacements of Center of Pressure - average x-axis speed

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).

    Assessment of postural stability during quiet standing for 30 seconds with eyes open and eyes closed. Average speed of COP displacement along the x-axis in centimeters per second (cm/s).

  44. Posturography - Displacements of Center of Pressure - average y-axis speed

    Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).

    Assessment of postural stability during quiet standing for 30 seconds with eyes open and eyes closed. Average speed of COP displacement along the y-axis in centimeters per second (cm/s).

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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