Cognitive Dysfunction
Conditions
Interventions
This is a randomized, controlled, parallel-group (two-arm), single-center clinical trial with blinded outcome assessors. The study will include 108 participants (54 per group), all aged 65 years or ol
Sponsors
Universidade Federal do Vale do São Francisco - UNIVASF
Universidade Federal do Vale do São Francisco - UNIVASF
Eligibility
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: To present cognitive complaints (self-reported or reported by family members) for at least six months and/or a score indicative of mild cognitive impairment on the Montreal Cognitive Assessment (MoCA), adjusted according to educational level; to be able to walk independently without assistive devices; to be able to stand up from and sit down on a chair unassisted while maintaining balance.
Exclusion criteria
Exclusion criteria: To present clinical conditions and/or diseases that contraindicate the safe practice of exercise; to have a diagnosis of neurological diseases and/or severe psychiatric disorders (e.g., dementia); to have a history of transient ischemic attack within the past year; to have a history of stroke with residual cognitive and/or motor impairments; to have significant sensory deficits (vision and/or hearing) that may interfere with the collection of study outcome data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe an improvement in the composite score of cognitive function, verified by the Montreal Cognitive Assessment, Trail Making Test part A, Digit Span Forward and Backward, Digit Symbol Substitution Test, and Verbal Fluency, considering score variations after 16 weeks of intervention.;It is expected to observe an increase in total, light, and moderate-to-vigorous physical activity time and a reduction in sedentary behavior, verified by accelerometry (GT3x-BT), considering mean variations after 16 weeks of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe an improvement in physical performance assessed by the Short Physical Performance Battery (SPPB), verified by the variation in total score after 16 weeks of intervention.;It is expected to observe an improvement in performance in the Chair Stand Test, verified by a reduction in the time (seconds) required to complete the test after 16 weeks of intervention.;It is expected to observe an improvement in performance in the Timed Up and Go (TUG) test, verified by a reduction in the time (seconds) required to complete the task after 16 weeks of intervention.;It is expected to observe an increase in usual, fast, and dual-task gait speed, verified by changes in mean velocity (m/s) after 16 weeks of intervention.;It is expected to observe an increase in muscle volume (thickness of the rectus femoris and vastus intermedius muscles) and an improvement in muscle quality (echo intensity and muscle architecture), verified by ultrasonography, considering mean variations after 16 weeks of intervention.;It is expected to observe improvements in cardiovascular risk factors, verified by measurements of brachial blood pressure (mmHg), waist circumference (cm), fasting glucose (mg/dL), glycated hemoglobin (%), triglycerides (mg/dL), total cholesterol (mg/dL), high-density lipoprotein – HDL (mg/dL), and low-density lipoprotein – LDL (mg/dL), assessed after 16 weeks of intervention.;It is expected to observe an improvement in sleep quality, verified by the Pittsburgh Sleep Quality Index (PSQI), considering changes in total score after 16 weeks of intervention.;It is expected to observe a reduction in symptoms of depression, anxiety, and stress, verified by the Depression, Anxiety and Stress Scale – Short Form (DASS-21), considering score variations after 16 weeks of intervention.;It is expected to observe an increase in purpose in life, verified by the Ryff & Keyes Purpose in Life Scale, considering changes in total score after 16 weeks of intervention.;It is | — |
Countries
Brazil
Contacts
Public ContactBruno Cavalcante
Universidade Federal do Vale do São Francisco - UNIVASF
Outcome results
None listed