Digital HEAL (Health and Exercise for Autonomous Longevity)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cognitive assessment
研究概览
简要总结
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.
The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.
- Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
- Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
- Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants' maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.
Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.
详细描述
Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.
The program is developed and implemented by the Department of Sports Sciences, the Faculty of Health Sciences, and the Department of Psychology and Education of the University of Beira Interior (UBI), in collaboration with the University of Turin. The principal investigator is Ricardo André Alves Bispo Madeira.
The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.
- Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
- Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
- Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants' maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants aged ≥ 65 years.
- •A score of ≥ 3 on the Short Physical Performance Battery (SPPB).
- •Willingness to participate in the training programs and collaborate with the research team.
- •Ability to provide informed consent, either oral or written.
排除标准
- •A score of ≤ 3 on the Short Physical Performance Battery (SPPB).
- •Presence of severe comorbidities that would negatively impact participation in the training program.
- •Presence of color blindness.
- •Diagnosis of severe dementia or severe impairment across multiple dimensions of cognition, which would prevent participation in the training program.
- •History of surgeries or fractures within the last 6 months.
- •These criteria ensure that participants are suitable for the program and capable of engaging in the training sessions effectively.
结局指标
主要结局
Cognitive assessment
时间窗: 3 months
The cognitive assessment protocol aims to evaluate multiple dimensions of cognition, including memory, concentration, attention, and executive cognitive functions, as well as their severity. The assessment will include the following validated tests: Mini-Mental State Illiterate \< 15 1 to 11 years of schooling \< 22 With more than 11 years of schooling \< 27
Quality of Life
时间窗: 3 months
Qality of Life PHQ-9 0 to 4: No depression. 5 to 9: Mild depression. 10 to 14: Moderate depression. 15 to 19: Moderately severe depression. 20 to 27: Severe depression.
Speed, agility and dynamic balance
时间窗: 3 months
The following physical fitness and health parameters will be evaluated: 6-Minute Walk Test (Distance) At the start signal, the subjects were instructed to walk as fast as possible (without running) for 6 minutes. During the test, the supervisor walked slightly behind the participant, avoiding accompanying them side by side so as not to influence the self-selected walking pace.
Strength assessment
时间窗: 3 months
The following physical fitness and health parameters will be evaluated: Seated Medicine Ball Throw (Meters) The seated medicine ball throw test measured upper body strength and power. Participants were seated on a chair, with the trunk against the chair back, holding a 3 kg medicine ball in front of the trunk with both hands. Rotation of the trunk and hips was restricted during the test. Three throws were performed with one-minute rest intervals to prevent fatigue. The distance from the point of release to where the ball contacted the ground was measured using a metric tape. The mean distance of the throws was used for subsequent analysis.
Flexibility assessment
时间窗: 3 months
The following physical fitness and health parameters will be evaluated: Chair Sit-and-Reach Test (Cm) Starting in a seated position, the participant moves their body forwards until they are sitting on the edge of the chair seat. The fold between the top of the leg and the buttocks should be level with the edge of the seat. With one leg bent and the foot fully on the ground, the other leg (the preferred leg) is extended towards the thigh, with the heel on the ground and the foot bent (approx. 90º). The participant should be encouraged to exhale as they flex forwards, avoiding sudden, rapid and strong movements, never reaching the limit of pain. With the leg extended (but not hyper-extended), the participant flexes slowly forwards as far as the hip joint (the spine should remain as straight as possible, with the head in the extension of the spine, therefore not flexed), sliding the hands (one over the other, with the fingertips overlapping) along the extended leg, trying to touch the t
Salivary assessment
时间窗: 3 months
Additionally, saliva samples will be analyzed for inflammatory markers such as IL-6 and IL-10, which have been reported in the literature as altered in individuals with dementia The assessment of biomarkers was conducted at baseline, after 6 weeks, and post-intervention. To ensure the quality of the samples collected, the experimental collection protocol adhered to strict guidelines. Sampling was consistently performed at the same time (9-11 a.m.) to account for the circadian rhythm of hormones and salivary proteins. The "passive drool" method (unstimulated saliva) was used, where participants sat comfortably, rinsed their mouth with water to remove any residue, and waited 10 minutes before collection began. Saliva was accumulated under the tongue and collected in Falcon tubes. The samples were then transferred to cryotubes and stored at -80 °C.
Body Composition Assessment
时间窗: 3 months
Bodyweight (kilogram) BMI The percentage of fat mass was assessed using bioelectrical impedance analysis (BC-BC-613; TANITA, United Kingdom). Body mass index (BMI) was calculated as weight (kg) divided by height squared (m\^2). Height measurements were taken using a stadiometer (Cabral, model 14). Participants removed their shoes and stood upright with feet flat on the floor, heels in contact, and their trunk and head positioned together against the stadiometer. The head position was neutral with the chin neither lifted nor tucked. Height measurements were recorded after participants exhaled.
Assessment of memory, concentration, attention and executive cognitive functions
时间窗: 3 months
Rey Auditory-Verbal Learning Test scores of ≤10 for more advanced dementia and ≤ 12 for mild/moderate
次要结局
未报告次要终点
研究者
Ricardo Madeira
PhD Student
University of Beira Interior