About this trial
The primary objective of this project is to examine the impact of a strength training program with high cognitive demands on cognitive function, motor skills, physical fitness, and quality of life in individuals with Alzheimer's disease and mild cognitive impairment. This randomized controlled trial will involve participants for a total of five months. Initial two weeks will be for cognitive, physical fitness, quality of life, and specific biochemical profile evaluations, along with familiarization sessions with the exercise routine. The experimental group will then undertake a supervised strength training program twice a week for 16 weeks. The final two weeks will involve re-evaluations of all initial assessments. Participants will be randomized into a control group and an intervention group with a minimum of 17 individuals each. Stratification criteria for randomization include physical activity level, number of Alzheimer's disease-related risk factors, extent of brain damage based on MRI biomarkers, and clinical dementia rating scores.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the criteria for early AD dementia (GDS 4) (according to the DSM-IV-TR and NINCDS-ADRDA criteria)
Have a score between 15 and 20 on the Mini-Mental State Examination scale (Trivedi, 2017), with criteria for moderate cognitive impairment.
Maintain a stable pharmacological regimen for at least 30 days prior.
Give consent to be evaluated using the cognitive screening tests described in this report.
Disqualifiers
Presence of heart disease or other diseases that lead to a contraindication in the practice of physical activity.
Presence of psychiatric illnesses.
Having some musculoskeletal pathology or alteration that does not allow the performance of the proposed exercises or proposed conditional evaluations.
Having a resting heart rate less than 50 or greater than 100 beats per minute.
Trial design
Parallel
Treatments tested in this trial
Interval strength training
Other interventionThe intervention involves interval strength training with biofeedback and real-time decision-making for Alzheimer\'s patients. Participants will complete 24 sessions, each including a circuit of strength exercises using rotational inertial devices (flywheels). Exercises, such as leg press, seated row, and bicep curl, will be randomly ordered, with load progression based on performance stability. Each session includes five sets per exercise, performed in a circuit, with a total of 15 sets over approximately 45 minutes. Real-time monitoring using a rotary encoder will track effort, and participants will continue each set until a 30% drop in average power is detected, ensuring consistent relative effort across sets. Additionally, participants will engage in cognitively demanding tasks during training by verbally reporting the average power of the previous repetition while performing the next one. This dual-task approach aims to maximize both physical and cognitive engagement.
Treatment groups
Trial outcomes
Primary outcomes
Global cognitive performance
Assessed using the Total Score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Clinical Assessment of Dementia
Global score obtained from the Clinical Dementia Rating Scale (CDR de Hughes).
Isometric knee flexion-extension strength
Changes in the isometric knee flexion-extension strength will be assessed using the Biodex isokinetic dynamometer.
Number of repetitions in the 30-second Sit-to-Stand test
Assessed using the 30-second Sit-to-Stand test. The participant is instructed to rise to a full standing position and sit down as many times as possible within 30 seconds without using the arms. The number of repetitions is recorded.
Secondary outcomes
Blood lactate concentration
Capillary blood lactate levels will be measured before and after one of the two weekly training sessions (randomly selected), throughout the 12-week intervention, in participants assigned to the experimental group.
Locations
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