Sarcopenia, Active Aging and Oral Microbiota in Older Adults. Effects of a High Intensity Exercises Program by Intervals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Relative abundance
研究概览
简要总结
To analyze the effects of a high intensity exercises program by intervals on sarcopenia, active aging and oral microbiota in older adults.
详细描述
All participants will be advised to lead healthy lifestyle habits according to the recommendations of the "Plan for the Promotion of Physical Activity and Balanced Eating of the Junta de Andalucía" http://www.juntadeandalucia.es/educacion/webporta/ishareservlet/content/86cf9950-abaa-403b-9fc3 9bc5ecae4614. A submaximal stress test will be performed at the beginning and end of the intervention. Before the test, the participants will become familiar with the measuring instrument with a warm-up that allowed them a gain in understanding the gear system. The test will start with a pedaling cadence of 50 revolutions, with an output power of 0 W, increasing by 25 W every 2 minute period. During the test there will be a continuous recording of blood pressure, heart rate and maximum oxygen consumption (VO2max). With this stress test, the aerobic and anaerobic threshold of each participant will be determined to mark the intensity of work at which each subject must perform physical activity in the intervention period.
The interventions of the 2 experimental groups are carried out with a frequency of 3 weekly trainings, for a total period of 16 weeks. The intensity of the training will be assigned to each subject individually based on the stress test performed in the previous phase. Experimental group 1 (HIIT): The HIIT protocol will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [HRM], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals 3 minute duration at 50-70% FCM. After the training, there will be a 10-minute cool down of gentle pedaling and joint range exercises. Experimental group 2 (MICT): Heating phase identical to the previous one. Subsequently, the participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually (Polar Team pro®). The session will conclude with a cool down phase identical to the previous one. Control group (CTRL): The participants will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity published by the Junta de Andalucía: http: // www.juntadeandalucia.es/salud/servicios/contenidos/andaluciaessalud/docs/130/Guia_Recomendaciones_AF.pdf
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •SARC-F ≥4 or handgrip strength <16 kg for women and < 27 kg for men.
- •Not being afflicted by any condition preventing physical activity.
- •Not being engaged in regular physical activity >20 minutes and >3 days/week.
- •Being able to communicate without difficulty.
- •Being able to read and understand the informed consent form as well as the goals of the study.
排除标准
- •Acute or terminal illness.
- •Unstable cardiovascular conditions.
- •Conditions or medical treatments affecting the normal production of saliva (i.e. autoimmune disorders such as Sjögren's syndrome or medications like anxiolytics or antidepressants).
- •Being or having been medicated with antibiotics up to one month prior to the taking of samples.
- •Alcohol abuse or regular drug abuse.
- •Severe visual or auditory impairment.
- •Being involved in a different research group with the potential to interfere in our results.
结局指标
主要结局
Relative abundance
时间窗: Up to twelve weeks
Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).
ABC-16 (Activities Specific Balance Confidence Scale)
时间窗: Up to twelve weeks
Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.
Handgrip Strength
时间窗: Up to twelve weeks
Dynamometer will be employed to assess handgrip Strength
Biodiversity
时间窗: Up to twelve weeks
Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.
FES-I (Falls Efficacy Scale-International)
时间窗: Up to twelve weeks
Questionnaire that evaluates the fear of falling. The score ranges from 7 to 28 points. Higher values indicate more concern related to falls.
PSQI (Pittsburgh Sleep Quality Index)
时间窗: Up to twelve weeks
A simple and valid evaluation of both the quality of sleep and the alterations that may affect it. It consists of a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven domains (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use, and daytime dysfunction, adding up to a total score) with their corresponding score, each one of which shows a range between 0 and 3 points. The higher value represents a worse result. The higher value represents a worse result. Higher bases indicate poorer sleep.
HADS (The Hospital Anxiety And Depression)
时间窗: Up to twelve weeks
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Percent of Body Fat (%)
时间窗: Up to twelve weeks
Indicates the percentage of body fat to body weight.
次要结局
- FSS (Fatigue Severity Scale)(Up to twelve weeks)
- Short Physical Performance Battery (SPPB)(Up to twelve weeks)
- Stabilometric Platform(Up to twelve weeks)
- TUG (Timed Up and Go test)(Up to twelve weeks)
- BMI (Body Mass Index)(Up to twelve weeks)
- SF-36 (The Short Form-36 Health Survey)(Up to twelve weeks)
- Percent of Body Fat (%)(Up to twelve weeks)
研究者
Agustín Aibar Almazán
Principal investigator
University of Jaén