Cognicise Training for Seniors for Healthy Aging

NCT07098533 | Completed

• 1 other identifier: 124/21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptom; Cognitive Functions; Quality of Life; Physical Fitness; Blood Biomarkers; Elderly (People Aged 65 or More); Postural Stability; Fall Risk; Postmenopausal Women; Cardiopulmonary

Keywords

elderly; yoga; cognicise; women; training; exercise

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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.

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

Secondary Outcomes (44)

• 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)

• Stroop Test - Number of Errors

  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)

Study Arms (3)

Yoga Group

EXPERIMENTAL

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

Cognicise Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Cognicise Group

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.

Yoga Group

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, Poland

Location

MeSH Terms

Conditions

Depression; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Piotr Gronek, Prof.

  Poznan University of Physical Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 1, 2025
• Study Start: April 4, 2023
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)