Effects of a Cognitive-Engaging Strength Training Program on Health, Physical Condition, and Quality of Life in People With Alzheimer's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorUniversity of Seville

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Interval strength training

    Other intervention

    The 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

34 Participants
are divided into 2 treatment groups
Group A: Strength trainingExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Global cognitive performance

Assessed using the Total Score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Time frame
Baseline (pre-intervention, week 0) and immediately after intervention (week 16).
2

Clinical Assessment of Dementia

Global score obtained from the Clinical Dementia Rating Scale (CDR de Hughes).

Time frame
Baseline (week 0) and immediately after the 12-week intervention (week 16)
3

Isometric knee flexion-extension strength

Changes in the isometric knee flexion-extension strength will be assessed using the Biodex isokinetic dynamometer.

Time frame
Baseline (week 0) and immediately after the 12-week intervention (week 16)
4

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.

Time frame
Baseline (week 0) and immediately after the 12-week intervention (week 16)

Secondary outcomes

1

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.

Time frame
During the 12-week intervention period (weeks 1 to 12)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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