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

NCT07022431 | Not Yet Recruiting

• 1 other identifier: SICEIA-2024-001871
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; Cognitive Function; High Cognitive Demand Exercises; Strength Training

Outcome Measures

Primary Outcomes (10)

• Global cognitive performance

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

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

• Clinical Assessment of Dementia

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

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

• Isometric knee flexion-extension strength

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

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

• 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.

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

• Handgrip strength

  Changes in the handgrip strength (handgrip test) assessed by Takei 5401

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

• 10m walking velocity

  Changes in the time taken to cover 10 meters (10m walk test).

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

• Time to complete the Timed Up and Go test (3 meters)

  Changes in the time needed to stand up from a chair, walk 3 meters, turn, return, and sit down (Timed Up and Go test).

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

• Decrement in walking speed during dual-task 10m walk test

  To assess possible improvements in dual-task exercises, we will use a variant of the previously described 10-meter walk test. The protocol being the same as above, while walking, participants will be instructed to perform the following cognitive tasks: in the first walk, they will receive the instruction "walk at your usual walking speed while naming the months backwards, starting from January"; in the second walk, they will receive the instruction "walk at your usual walking speed while counting backwards from 50". In total, participants will perform three attempts of each verbal instruction. The best time will be taken as the final result. Finally, the decrement in performing this modified test compared to the original will be calculated, using the following formula ((10m dual task - 10m single task)/10m single task X 100).

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

• Health-related quality of life measured by EuroQol-5D (EQ-5D)

  Quality of life will be assessed using the EuroQol-5D questionnaire (EQ-5D), a standardized instrument to measure health-related quality of life across five dimensions. Both patient and caregiver reports will be considered.

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

• Distance walked in the 6-Minute Walk Test (6MWT)

  Changes in the distance (in meters) covered during the 6-Minute Walk Test (6MWT), a submaximal aerobic capacity test commonly used in elderly and clinical populations.

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

Secondary Outcomes (1)

• Blood lactate concentration

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

Study Arms (2)

Strength training

EXPERIMENTAL

Participants will perform a cognitively demanding exercise while simultaneously performing strength training. With each repetition, the software will display in numbers the average concentric power output performed by the participants. Based on the benefits of performing a cognitively demanding physical exercise, participants will be asked to repeat out loud the value of the average concentric power output of the previous repetition while performing the next one.

Other: Interval strength training

Control group

NO INTERVENTION

These patients only receive the usual treatment for their pathology.

Interventions

Interval strength training OTHER

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.

Strength training

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Be available to attend in person weekly at the headquarters where the training will take place in Seville capital.

You may not qualify if:

• 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.
• Having a diagnosed intellectual disability.

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Alejandro Muñoz López

CONTACT

+34955421006; amunoz26@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: June 15, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06