Parkinson's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Have clinical diagnosis of idiopathic PD according to the criteria of clinical diagnosis of the United Kingdom Parkinsons Disease Society Brain Bank (Hughes et al., 1992); Age above 40 years; To be in stage 1,5 to 3 of Hoehn & Yahr; Be in use of l-dopa and clinically stable; Being able to wander independently or with the use of auxiliary devices; Have medical release for performing aerobic training.
Exclusion criteria
Exclusion criteria: To have impairment of cognitive function according to the score of the Mini-Exam of the Mental State (cut-off point 13 for illiterate, 18 for low and medium schooling and 26 for high schooling); Have intense dyskinesia that interferes with postural stability; Have other neurological and psychiatric diseases; To present musculoskeletal changes that make difficult the accomplishment of the exercises; To present rheumatologic diseases that interfere in the concentration of mediators inflammatory drugs; Have an unstable cardiovascular condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the serum concentration of inflammatory mediators and neurotrophic factors. Approximately 10 mL of venous blood from the ulnar vein will be collected in a tube with no additive to obtain serum. The collection will be done before and after the training. The concentrations of anti-and pro-inflammatory mediators: IL-6, soluble receptors of TNF (sTNFR1 and sTNFR2) and IL-10 and neurotrophic: BDNF and GDNF will be measured in the plasma / serum by the enzyme-linked immunosorbent assay (ELISA) technique.;Another measure of primary outcome will be the leukocyte analysis. Approximately 10 mL of venous blood from the ulnar vein will be collected in a heparin tube. The collection will be done before and after the training. For the immunophenotyping of peripheral blood mononuclear cells, the flow cytometry technique will be used.;For primary outcome, the lactate level will be evaluated. Blood lactate concentrations will be performed using the Accutrend Plus Roche Monitor and ROCHE lactate strips. The collection will be done before and after the training. ;Hematological parameters (leukocyte count) will be performed at Cell Dyn Ruby Abbott. Approximately 10 mL of venous blood from the ulnar vein will be collected in EDTA tube. The collection will be done before and after the training. ;Oral mucosa scraping will still be collected from all participants who complete the intervention for analysis of BDNF polymorphism. To collect the scrap samples from the jugal mucosa will be used sterile plastic spatula that will be stored in buffer (Krebs) and the extraction of DNA will be done according to the protocol previously described. For the comparison of the variables of the same group or between groups, the T test (paired or unpaired sample) will be performed when the distribution is parametric and the Wilcoxon or Mann Whitney test when the distribution is not parametric. The level of significance will be set at p <0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be the cognitive function assessed by the Montreal Cognitive Assessment (MoCA). ;Fatigue assessment by the Fatigue Severity Scale (FHS). ;Depression assessed by the Beck Depression Inventory (BDI). ;Evaluation of balance by Mini-Balance Evaluation Systems Test (Mini-BESTest).;The mobility assessed by the 10-meter test (T10m), Timed Up and Go (TUG) test and five-sit-up test (TLS). ;Cooperability test for exercise test.;Evaluation of activities of daily living by the Questionnaire of daily life activities for patients with Parkinson's disease. ;Quality of life assessment by the Quality of Life Questionnaire for Parkinson's Disease (PDQ-39). All measurements will be collected before and after the 12-week intervention. For the comparison of the variables of the same group or between groups, the T test (paired or unpaired sample) will be performed when the distribution is parametric, and the Wilcoxon or Mann Whitney test when the distribution is not parametric. The level of significance will be set at p <0.05. | — |
Countries
Brazil
Contacts
Universidade Federal de Minas Gerais;Universidade Federal de Minas Gerais