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临床试验/NCT07118423
NCT07118423已完成不适用

Effects of Resistance Training in Centenarians

Universidad de Zaragoza1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Frailty using Fried's Frailty Criteria

研究概览

简要总结

This study is a multicenter intervention evaluating the effectiveness and safety of resistance training in institutionalized centenarians.

The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.

详细描述

Although exercise interventions have shown benefits in octogenarians and nonagenarians, their potential for improving predictors of healthy ageing has not yet been explored in institutionalized centenarians

The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.

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
None

入排标准

年龄范围
100 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Women and men aged 100 years and over living in geriatric nursing homes.

排除标准

  • •Participants were excluded if they were bedridden, going through an acute disease or presented any clinical condition contraindicating physical exercise as outlined in the American College of Sports Medicine's Guidelines.

研究组 & 干预措施

Control group

No Intervention

The control group received the usual care in nursing homes.

Exercise group

Experimental

The exercise group performed twice per week, nonconsecutive, resistance training over 12 weeks. Exercise sessions consisted of 1-3 sets of the 8-exercise routine at 50-70% of the estimated one-repetition maximum.

干预措施: Exercise (Other)

结局指标

主要结局

Frailty using Fried's Frailty Criteria

时间窗: T0 (baseline) and T1 (post 12 weeks)

Fried's frailty phenotype is based on five criteria (habitual gait speed, handgrip strength , involuntary weight loss, exhaustion and low physical activity). The score ranges from 0 to 5, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 5 indicates worst status.

Physical function using the Time Up and Go test.

时间窗: T0 (baseline) and T1 (post 12 weeks)

The Timed Up and Go test measures the time it takes participants to stand up, walk 3 meters, turn around, and sit back down. Shorter times reflect better mobility

Isometric muscle strength

时间窗: T0 (baseline) and T1 (post 12 weeks)

Maximum voluntary isometric strength in handgrip, knee extension, elbow flexion and should abduction, measured using a dynamometer.

Albumin

时间窗: T0 (baseline) and T1 (post 12 weeks)

Albumin concentration is measured in blood samples.

C-reactive protein

时间窗: T0 (baseline) and T1 (post 12 weeks)

C-reactive protein concentration is measured in blood samples.

Frailty using Frailty Trait Scale - Short Form

时间窗: T0 (baseline) and T1 (post 12 weeks)

Frailty Trait Scale - Short Form evaluates 5 domains, including body mass index, physical activity, static balance, habitual gait speed and handgrip strength. The score ranges from 0 to 50, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 50 indicates worst status.

Physical function based on the Short Physical Performance Battery

时间窗: T0 (baseline) and T1 (post 12 weeks)

The Short Physical Performance Battery is based on the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions, time to walk 4 meters, and time to rise from a chair and return to the seated position 5 times. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.

Physical function using Physical Performance Mobility Examination.

时间窗: T0 (baseline) and T1 (post 12 weeks)

The Physical Performance Mobility Examination includes six mobility tasks integral to daily life: bed mobility, transfer skills, multiple stands from chair, standing balance, step-up, and ambulation. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.

Physical function based on the gait speed in 6 meters.

时间窗: T0 (baseline) and T1 (post 12 weeks)

Gait speed is measured in meters per second (m/s). Higher values indicate better mobility.

Cognitive function using Mini Mental State Examination.

时间窗: T0 (baseline) and T1 (post 12 weeks)

Mini Mental State Examination questionnaire incorporates 11 items that measure attention and orientation, memory, registration, recall, calculation, language, and ability to draw a complex polygon, and results in scores ranging from 1 (lowest cognitive function) to 30 (highest cognitive function) points.

Cognitive function using the animal naming test within 1 minute.

时间窗: T0 (baseline) and T1 (post 12 weeks)

In the animal naming test, participants are asked to name as many animals as possible in 60 seconds. The higher number of correctly named reflects better cognitive function.

Cognitive function using the clock drawing test.

时间窗: T0 (baseline) and T1 (post 12 weeks)

The score in the clock drawing test ranges from 0 to 10. This score evalutes visuospatial skills, executive functions, and the ability to follow instructions. Higher scores indicate better cognitive function.

Quality of life using Visual Analog Scale.

时间窗: T0 (baseline) and T1 (post 12 weeks)

Visual Analog Scale evaluates self-reported quality of life on a vertical scale ranging from 0 (worst health) to 100 (best health). This score provides a subjective measure of the patient's perception of their current health status.

Muscle power

时间窗: T0 (baseline) and T1 (post 12 weeks)

Muscle power assessed in 30-s sit-to-stand test.

Quality of life using EuroQoL-5 Dimension questionnaire.

时间窗: T0 (baseline) and T1 (post 12 weeks)

EuroQoL-5D Index ranges from a value of 1 (best state of health) to 0 (death). Although there are negative values for the index, corresponding to those states of health that are valued as worse than death.

Falls

时间窗: T0 (baseline) and T1 (post 12 weeks)

The number of falls in the last year was registered.

Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1)

时间窗: T0 (baseline) and T1 (post 12 weeks)

Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1) are measured in blood samples.

Disability

时间窗: T0 (baseline) and T1 (post 12 weeks)

The Barthel index is a 10-item questionnaire that provides information about the autonomy to cook food, wash, dress, groom, perform bowel movements and urination, go to the toilet, move from the bed to the chair, walk and climb stair. The total score ranges from 0 to 100, with higher scores indicating greater independence (best), and lower scores indicating higher levels of dependence in basic daily activities.

Accelerometer-based physical activity

时间窗: T0 (baseline) and T1 (post 12 weeks)

Measurement of physical activity levels (i.e., time spent in light-intensity and moderate-to-vigorous intensity) by accelerometer 24 hours a day for seven consecutive days using a GENEActiv device worn on the non-dominant wrist.

Heart rate variability indices from electrocardiogram (ECG)

时间窗: T0 (baseline) and T1 (post 12 weeks)

Heart rate variability indices were derived from 10-minute resting recordings using a 12-lead Holter ECG. Both linear indices (time and frequency domains) and non-linear indices (detrended fluctuation ) were calculated from the ECG recording.

Blood pressure

时间窗: T0 (baseline) and T1 (post 12 weeks)

Blood pressure is measured in millimeters of mercury (mmHg), including systolic, diastolic, and mean arterial pressure (calculated as diastolic pressure plus one-third of the difference between systolic and diastolic pressures).

Ankle-brachial index relate to blood pressure

时间窗: T0 (baseline) and T1 (post 12 weeks)

The ankle-brachial index (ABI) is calculated by measuring systolic pressure in both ankles and both arms. The highest systolic pressure from the arms is used as a reference. The highest systolic pressure from each ankle is divided by this reference to obtain an ABI for each leg. The final ABI value is the lower of the two leg measurements.

inflammatory cytokines

时间窗: T0 (baseline) and T1 (post 12 weeks)

Inflammatory cytokines (IL-6 and IL-1β) are measured in blood samples.

Circulating microRNA levels

时间窗: T0 (baseline) and T1 (post 12 weeks)

MicroRNAs associated with frailty (miR-194-5p, miR-125b-5p) are measured in blood samples.

次要结局

  • Resilience(Only baseline (T0))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrián Hernández-Vicente

PhD

Universidad de Zaragoza

研究点 (1)

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