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临床试验/NCT05465811
NCT05465811已完成不适用

Effects of Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context: A Pilot Study

Paulista University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Physical Performance

研究概览

简要总结

Introduction: Due to the COVID-19 pandemic scenario, social distancing has become the main strategy to contain this pandemic, causing negative impacts on the physical and mental health of the elderly population. To promote the continuity of offering health services during isolation telerehabilitation was used. Thus, it is important to investigate the effect of a physical exercise program and health education through telerehabilitation on physical and mental aspects in order to establish it as an alternative care for the elderly. Objectives: To evaluate the effect of a program of physical exercises and health education by telerehabilitation on signs of sarcopenia, physical performance, hand grip strength and levels of anxiety, depression and sleep quality in elderly women. Method: In this non-randomized clinical trial, considered a pilot study, eight elderly women (73,00±4,69 years old) will be submitted to 16 weeks of intervention through a program of physical exercise and health education using the Google Meet platform (synchronous online), frequency of 3 weekly sessions and duration of 50' (Initial rest: 5'; Warm-up: 15': Resistance exercises: 20'; Stretching exercises: 5'; Relaxation and final rest: 5'). Before and after the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index. To compare the two moments, the paired Student's T-test or Wilcoxon test (normality assessed by the Shapiro-Wilk test) will be used with p<0.05.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 60 years or older;
  • Able to perform all the proposed assessments;
  • Not present cognitive impairment according to the assessment of mental status through the Mini Mental State Examination;
  • Participate in the supervised physical exercise program in person, prior to the beginning of the COVID-19 pandemic.

排除标准

  • had a frequency of participation in the program below 75%.

结局指标

主要结局

Physical Performance

时间窗: This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

Physical performance will be evaluated using the SPPB, a simple tool that can help to track the risk of falls by identifying risk factors related to the assessed domains. This tool has three domains: static balance, lower limbs strength and gait speed. The total SPPB score is made by adding these three domains and can vary between 0 and 12 points.

Signs of sarcopenia

时间窗: This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

Sarcopenia will identify and track by the SARC-F questionnaire, composed of five self-reported questions, based on muscle strength activities, ambulation, rising from a chair, climbing stairs and history of falls, in combination with measurement of the right calf circumference as an indirect assessment of muscle mass. The total score will obtain by means of the sum of the questions (maximum 2 points for each) and the measurement of calf circumference (women: \> 33 cm = 0; ≤ 33cm =10 points). This questionnaire is valid for Portuguese Language since 2016.

Hand Grip Strength

时间窗: This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

Hand grip strength will be assessed using a manual dynamometer (Crown produced by the industrial technique Oswaldo Filizola Ltda) with a capacity of 50 kilograms-force, following the protocol proposed by Robert et al. During the test, the participant remains seated with the forearms resting on the arms of the chair with wrists in a neutral position and her thumbs facing up. The evaluator assists by holding the base of the dynamometer in the palm of the hand in order to nullify the effect of gravity on the test, while the participant holds the dynamometer. In this way, the patient is asked to press as long and strong as possible or until the pointer stops rising. The test is performed three times in each hand, alternating between them, with an interval of 20 seconds for each attempt. The value recorded regarding strength was the highest among the six measures.

Depressive symptoms

时间窗: This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

The GDS-15 is a self-assessment scale that analyzes the presence of suspected depression in the elderly, easy to apply and low cost. Its reduced version consists of 15 questions, with dichotomous answers (yes/no), in which 0 points are scored when the answer is different from the example in parentheses and 1 point when the answer is the same as the example in parentheses. A 5-point cut-off for the GDS-15 indicates the presence of suspected depression.

Anxiety symptoms

时间窗: This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

The GAI is an instrument designed to assess anxiety symptoms in elderly individuals, with viable application in situations of fatigue, low educational level or mild cognitive impairment. The inventory consists of 20 items with dichotomous responses, with a cut-off point of 10/11 for the detection of generalized anxiety disorder. The GAI will be translated and adapted into Brazilian Portuguese, called the Geriatric Anxiety Inventory (GAI-BR), contributing to a quick, effective and low-cost evaluation with satisfactory validity.

Sleep quality

时间窗: This outcome will be evaluated in two different moments. The first evaluation will be performed at baseline and the second evaluation will be perfomed after 16 weeks of telerehabilitation (follow-up)

The PSQI is a questionnaire composed of 21 items that assesses subjective quality of sleep and disorders over the last month, in which 19 questions are self-assessment and 5 questions that must be answered by bedmates or roommates. The PSQI analyzes seven issues: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of sleeping medications, and daytime dysfunction. Its score ranges from 0 to 21 and indicates the overall quality of sleep, classifying individuals into good sleep quality (score less than 5) and poor sleep quality (score greater than 5), that is, the lower the score, the better the sleep quality score.

次要结局

未报告次要终点

研究者

发起方
Paulista University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Franciele Marques Vanderle

Assistant Professor

Paulista University

研究点 (2)

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