Effects of a Strength Training Program With High Cognitive Engagement on Health, Physical Condition, and Quality of Life in People With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Global cognitive performance
研究概览
简要总结
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.
详细描述
Objectives and Hypotheses:
The main objective of this project is to study the effects of a physical exercise program based on strength training with high cognitive implications on cognitive, motor, conditional function, and quality of life in people with Alzheimer's Disease with mild cognitive impairment.
Design:
This study follows a randomized controlled experimental design. Participants will be involved in the study for a total of five months. During the first two weeks, participants will be evaluated regarding their cognitive function, physical condition, quality of life, and specific biochemical profile. Additionally, during these two weeks, they will undergo familiarization sessions with the exercise routine. Subsequently, the experimental group will perform supervised strength training, two days a week with 48-72 hours of separation between sessions, for a total of 16 weeks. The last two weeks will involve retesting all the evaluations conducted during screening and pre-intervention.
Participants will be stratified and randomized into a control group (minimum n=17) and an intervention group (minimum n=17). Randomization will consider the following strata: 1) level of physical activity, 2) number of risk factors associated with Alzheimer's disease, 3) degree of brain damage according to MRI neuroimaging biomarkers, and 4) Clinical Dementia Rating (CDR). The level of physical activity will have two groups: 1) physically active, those engaging in moderate to vigorous activity for more than 150 minutes per week, or 2) physically inactive (less than 150 minutes per week), evaluated through the adapted International Physical Activity Questionnaire for the elderly (IPAQ-E). The number of associated risk factors will have the following groups: 1) presents 3 or fewer factors, 2) presents between 4 and 7 factors, 3) presents 8 or more factors. The degree of brain damage according to biomarkers will have the following groups, based on hippocampal atrophy degree by volume: 1) 30th percentile of participants, 2) 30th to 60th percentile, 3) 60th percentile onwards. The CDR score will have the following groups: 1) up to questionable dementia (CDR < 0.5), 2) from mild dementia (CDR > 1). The control group will be instructed to maintain their normal life habits concerning physical activity levels, cognitive training, and diet. The experimental group will follow the training plan described later. The design of this study follows the procedures previously approved in the Declaration of Helsinki - ethical principles for medical research involving human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Strength training
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.
干预措施: Interval strength training (Other)
Control group
These patients only receive the usual treatment for their pathology.
结局指标
主要结局
Global cognitive performance
时间窗: Baseline (pre-intervention, week 0) and immediately after intervention (week 16).
Assessed using the Total Score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Clinical Assessment of Dementia
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
Global score obtained from the Clinical Dementia Rating Scale (CDR de Hughes).
Isometric knee flexion-extension strength
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
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
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
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.
Handgrip strength
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
Changes in the handgrip strength (handgrip test) assessed by Takei 5401
10m walking velocity
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
Changes in the time taken to cover 10 meters (10m walk test).
Time to complete the Timed Up and Go test (3 meters)
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
Changes in the time needed to stand up from a chair, walk 3 meters, turn, return, and sit down (Timed Up and Go test).
Decrement in walking speed during dual-task 10m walk test
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
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).
Distance walked in the 6-Minute Walk Test (6MWT)
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
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.
Health-related quality of life measured by EuroQol-5D (EQ-5D)
时间窗: Baseline (week 0) and immediately after the 12-week intervention (week 16)
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.
次要结局
- Blood lactate concentration(During the 12-week intervention period (weeks 1 to 12))
研究者
Alejandro Muñoz López
Assistant Professor
University of Seville