Neurodegenerative and mental disorders, Alzheimer's disease, schizophrenia Mental and Behavioural Disorders
Conditions
Interventions
Clinical trial no. 1
The first clinical trial will include people aged 60+ (with only age-related diseases and without neurodegenerative and mental disorders) - one control group and one experimental
Sponsors
Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/11/2024: Clinical trial no. 1 1.1. Women and men aged = 60, 1.2. Written consent to participate in the study, 1.3. The ability to understand and follow the therapist's instructions, 1.4. Everyday functional efficiency assessed on the Barthel index above 20 points, 1.5. Cognitive efficiency assessed using the mini-mental state examination test, at the level of 26 - 30 points. Clinical trial no. 2 2.1. Women and men aged = 60, 2.2. I or II stage of Alzheimer's disease, 2.3. Written consent from the participant or his legal health care provider to participate in the study, 2.4. The ability to understand and follow the therapist's instructions, 2.5. Everyday functional efficiency assessed on the Barthel index above 20 points, 2.6. Cognitive efficiency assessed using the mini-mental state examination test at the level of 11 - 24 points. Clinical trial no. 3 3.1. Women and men aged = 18, 3.2. Clinically confirmed schizophrenia for at least 5 years, with predominance of negative symptoms, 3.3. Unchanged pharmacotherapy for at least 3 months, 3.4. Written consent from the patient or his legal medical provider to participate in the study, 3.5. The ability to understand and follow the therapist's instructions, 3.6. Everyday functional efficiency assessed on the Barthel index above 20 points, 3.7. Cognitive efficiency assessed using the mini-mental state examination test at the level of above 19 points. _____ Previous inclusion criteria: Clinical trial no. 1 1.1. Women and men aged = 60, 1.2. Written consent to participate in the study, 1.3. The ability to understand and follow the therapist's instructions, 1.4. Everyday functional efficiency assessed on the Barthel index above 20 points, 1.5. Cognitive efficiency assessed using the mini-mental state examination test, at the level of 26 - 30 points. Clinical trial no. 2 2.1. Women and men aged = 60, 2.2. I or II stage of Alzheimer's disease, 2.3. Written consent from the participant or his legal health care provider to participate in the study, 2.4. The ability to understand and follow the therapist's instructions, 2.5. Everyday functional efficiency assessed on the Barthel index above 20 points, 2.6. Cognitive efficiency assessed using the mini-mental state examination test at the level of 11 - 24 points. Clinical trial no. 3 3.1. Women and men aged = 18, 3.2. Clinically confirmed schizophrenia for at least 5 years, with predominance of negative symptoms, 3.3. Unchanged pharmacotherapy for at least 3 months, 3.4. Written consent from the patient or his legal medical provider to participate in the study, 3.5. The ability to understand and follow the therapist's instructions, 3.6. Everyday functional efficiency assessed on the Barthel index above 20 points, 3.7. Cognitive efficiency assessed using the mini-mental state examination test at the level of 19 - 24 points.
Exclusion criteria
Exclusion criteria: Clinical trial no. 1 1.1. Contraindications to the exercises applied in the study, 1.2. Neurodegenerative and mental diseases, 1.3. Diseases of the nervous system (neuropathy, stroke, damage to the cerebellum, inner ear and labyrinth of the ear, Parkinson's disease), 1.4. Illnesses and diseases of the musculoskeletal system that disturb the balance of the body and the mobility of the limbs. Clinical trial no. 2 2.1. Contraindications to the exercises applied in the study, 2.2. III stage of Alzheimer's disease; 2.3. Diseases of the nervous system (neuropathy, stroke, damage to the cerebellum, inner ear and labyrinth of the ear, parkinson's disease and others affecting functional efficiency and posture control), 2.4. Illnesses and diseases of the musculoskeletal system that disturb the balance of the body and the mobility of the limbs. Clinical trial no. 3 3.1. Contraindications to the exercises applied in the study, 3.2. Diseases of the nervous system and sense organs (neuropathy, stroke, damage to the cerebellum, inner ear and labyrinth of the ear, parkinson's disease and others affecting functional efficiency), 3.3. Illnesses and diseases of the musculoskeletal system that impair functional efficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical trial no. 1 (people aged 60+ with only age-related diseases and without neurodegenerative and mental disorders) 1. Cognitive functions assessed by Mini-Mental State Examination Test (MMSE), at baseline and after the 15-week rehabilitation period. 2. Cognitive functions assessed by verbal fluency test at baseline and after the 15-week rehabilitation period. 3. Cognitive functions assessed by Digit Symbol Substitution Test (DSST), at baseline and after the 15-week rehabilitation period. 4. Cognitive functions assessed by reverse number memorization test, at baseline and after the 15-week rehabilitation period. 5. Cognitive functions assessed by Stroop test, at baseline and after the 15-week rehabilitation period. 6. Cognitive functions assessed by Reven's test, at baseline and after the 15-week rehabilitation period. 7. Cognitive functions assessed by Rey's 15 words test, at baseline and after the 15-week rehabilitation period. 8. Activities of daily living assessed by Barthel Index, at baseline and after the 15-week rehabilitation period. 9. Functional fitness assessed by Fullerton Test (Functional Fitness Test), at baseline and after the 15-week rehabilitation period. 10. Static and dynamic body balance assessed by stabilometric platform (Zebris FDM-S; Rehawalk, MaxxusDaum h/p Cosmos Force), at baseline and after the 15-week rehabilitation period. 11. Emotional state assessed by Center for Epidemiologic Studies Depression Scale (CES-D), at baseline and after the 15-week rehabilitation period. 12. Quality of life assessed with WHOQOL-BREF questionnaire, at baseline and after the 15-week rehabilitation period. Clinical trial no. 2 (people aged 60+ with Alzheimer's disease) 1. Cognitive functions assessed by Mini-Mental State Examination Test (MMSE), at baseline and after the 15-week rehabilitation period. 2. Cognitive functions assessed by verbal fluency test at baseline and after the 15-week rehabilitation period. 3. Cognitive functions ass | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical trial no. 1 Laboratory indicators (anti and pro-inflammatory cytokines, cortisol, creatine kinase, fibrinogen, lactate dehydrogenase, C-reactive protein) measured by laboratory blood tests at baseline and after the 15-week rehabilitation period. Clinical trial no. 2 Laboratory indicators (anti and pro-inflammatory cytokines, cortisol, creatine kinase, fibrinogen, lactate dehydrogenase, C-reactive protein) measured by laboratory blood tests at baseline and after the 15-week rehabilitation period. Clinical trial no. 3 Laboratory indicators (basic biochemistry blood tests and anti and pro-inflammatory cytokines, adhesion proteins, neurotrophins, brain-derived growth factor (BDNF), creatine kinase, fibrinogen, lactate dehydrogenase, CRP) measured by laboratory blood tests at baseline and after the 15-week rehabilitation period. | — |
Countries
Poland
Outcome results
None listed