Cognicise Training for Seniors for Healthy Aging

NCT ID: NCT07098533

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2023-06-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoga Training

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Cognicise Training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognicise Training

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.

Intervention Type: BEHAVIORAL

Yoga Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Gronek, Prof.

Role: STUDY_CHAIR

Poznan University of Physical Education

Locations

Poznan University of Physical Education

Poznan, , Poland

Countries

Poland

Other Identifiers

124/21

Identifier Type: -

Identifier Source: org_study_id