An interventional study of Cognicise Training and Yoga Training in Depressive Symptom, Cognitive Functions and Quality of Life, sponsored by Poznan University of Physical Education. Completed at 1 site in Poland. Open to female participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Prevention
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 70 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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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.
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.
Behavioral: Yoga Training
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.
Behavioral: Cognicise Training
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.
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.
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.
Maximal Oxygen Uptake (VO₂max)
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)
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Geriatric Depression Scale (GDS)
GDS-15 (15 items). Scores range from 0 to 15; higher scores indicate more severe depressive symptoms. Units: score (0-15; higher = worse outcome)
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Brain-Derived Neurotrophic Factor (BDNF)
Serum concentration of BDNF measured in fasting blood samples collected in the morning. Units: ng/mL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Rosenberg Self-Esteem Scale
Stroop test10-item scale. Scores range from 0 to 30; higher scores indicate greater self-esteem. Units: score (0-30; higher = better outcome).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Beck Depression Inventory (BDI-II)
21-item inventory. Scores range from 0 to 63; higher scores indicate greater depressive symptoms. Units: score (0-63; higher = worse outcome).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Stroop Test - Completion Time
Time (in seconds) to complete the interference condition of the Stroop Test. Lower values indicate better executive functioning. Units: seconds (s).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Stroop Test - Number of Errors
Number of errors during the interference condition. Lower scores indicate better cognitive control. Units: count.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Body Mass Index (BMI)
Calculated as body mass (kg) divided by height (m) squared. Units: kg/m².
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Fat Mass
Body fat percentage measured using bioimpedance analysis. Units: %.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Muscle Mass
Skeletal muscle mass percentage via bioimpedance analysis. Units: %.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Visceral Fat
Visceral fat level assessed via bioimpedance analysis, expressed as an index score. Units: score.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Chest Expansion
Thoracic expansion measured with tape during maximum inspiration and expiration. Units: centimeters (cm).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Vital Capacity - Percentage of Predicted
Vital capacity expressed as a percentage of predicted value based on age, sex, and height. Units: %.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Minute Ventilation (VE)
Volume of air exhaled per minute. Units: liters per minute (L/min).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Tidal Volume (TV)
Volume of air exhaled in one breath. Units: milliliters (mL).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Respiratory Rate (RR)
Number of breaths per minute during resting conditions. Units: breaths per minute (brpm).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
FEV1/FVC Ratio
Ratio of forced expiratory volume in one second to forced vital capacity. Units: percentage (%).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Maximal Expiratory Flow (MEF75, MEF50, MEF25)
Maximal flow at selected points of forced expiration, expressed as a percentage of predicted. Units: percentage (%).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Heart Rate (HR)
Measured at rest using standard heart rate monitor. Units: beats per minute (bpm).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Systolic Blood Pressure (SBP)
Measured in mmHg using standard sphygmomanometer. Units: millimeters of mercury (mmHg).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Diastolic Blood Pressure (DBP)
Measured in mmHg using standard sphygmomanometer. Units: millimeters of mercury (mmHg).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Borg Rating of Perceived Exertion (RPE)
Subjective perception of exertion using a 1-10 scale. Units: score (1-10).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
White Blood Cells (WBC)
Measured from fasting serum sample. Units: mg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Red Blood Cells (RBC)
Total erythrocyte count. Units: 10¹²/L.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Hemoglobin (HGB)
Hemoglobin concentration in blood. Units: g/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Hematocrit (HCT)
Proportion of blood volume occupied by red cells. Units: percentage (%).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Red Cell Distribution Width (RDW-CV)
Coefficient of variation of red blood cell size distribution. Units: percentage (%).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Platelets (PLT)
Platelet count. Units: 10⁹/L.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Differential white blood cell count. Units: percentage (%).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Total Cholesterol (TC)
Measured from fasting serum sample. Units: mg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
HDL Cholesterol (HDL)
High-density lipoprotein cholesterol. Units: mg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
LDL Cholesterol (LDL)
Low-density lipoprotein cholesterol. Units: mg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Triglycerides (TG)
Serum triglyceride concentration. Units: mg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Glucose (GLU)
Fasting glucose concentration. Units: mg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Thyroid Stimulating Hormone (TSH)
Serum TSH level. Units: μIU/mL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Insulin (INS)
Serum insulin concentration. Units: μIU/mL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Cortisol (COR)
Morning serum cortisol level. Units: µg/dL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Testosterone (TES)
Total serum testosterone concentration. Units: ng/mL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Testosterone to Cortisol Ratio (T/C)
Ratio of serum testosterone to cortisol. Units: unitless (arbitrary units).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Glial Cell Line-Derived Neurotrophic Factor (GDNF)
Serum concentration of GDNF. Units: ng/mL.
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program)
Irisin (IRS)
Serum irisin concentration. Units: ng/mL.
Time frame: 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:
Total path length of center of pressure displacement during quiet standing. Units: mm.
Time frame: 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
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: Baseline (within 3 days before intervention) and Post-intervention (within 3 days after the 8-week program).
Plan to share: Yes
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Poznan University of Physical Education