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临床试验/NCT05991505
NCT05991505已完成不适用

Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Quality of sleep

研究概览

简要总结

The objective of the present study was to verify the impact of physical exercise at a distance (EFAD) on the level of mobility and quality of sleep of hypertensive elderly women. To this end, hypertensive elderly women under drug treatment aged between 60 and 79 years old age, without orthopedic limitations and/or cardiovascular complaints were assessed using questionnaires, functional tests, sleep scale classification and use of actigraphy for 7 days. Afterwards, they were randomized into 2 groups, control and EFAD, with synchronous training online 2x/week and by recorded class 1x/week. Reassessments were made after 10 weeks.

详细描述

Weight was checked using an OMRON model HBF-214 scale and height was checked using a 2-meter Slim Fit compact stadiometer, after which the body mass index (BMI) was calculated. All procedures took approximately 35 minutes, supervised by the researcher in charge. The researcher used personal protective equipment, such as an N95 mask and frequent use of alcohol gel on hands and surfaces. All participants and researchers involved in the study were vaccinated against SARS COV-2 according to the health status of the study period.

Physical tests were performed after measuring blood pressure (BP) with values equal to or less than 160x100 mmHg. The Timed Up and Go (TUG) test was performed to assess the participants' mobility and risk of falling. Studies show a greater risk of falling with times above 20 seconds. After the TUG, the gait speed test was performed, as it is an important predictor of cardiovascular health. In this test, a speed equal to or greater than 0.89 meters per second is expected in elderly people with preserved capacity.

Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire . There are 19 questions grouped into seven categories: subjective sleep quality; sleep latency; nocturnal sleep duration; sleep effectiveness; sleep disorders; sleeping pills; daytime sleepiness. Each category is scored from 0 to 3, allowing a total sum of 0 to 21. Values above 9 in the total sum indicate poor sleep quality. This questionnaire is validated and widely used. In addition to this questionnaire, the Epworth sleepiness scale was used, containing 8 questions with scores from 0 to 3 points in each situation, with abnormal sleepiness classification above 9 points.

Subjects were also assessed for sleep quality with actigraphy. The ActTrust device, Condor Instruments - Brazil was used. The device was placed on the participant's non-dominant wrist. Participants' activities were monitored for a period of 7 days (24 hours), allowing for an objective analysis of sleep quality. At the end of this period, a new home visit was carried out to remove the actigraph and the information was transferred through a USB interface and specific software that performed the data analysis.

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
60 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • hypertensive women in regular use of medication prescribed for high blood pressure, physically active, and with basic knowledge to use smartphones, tablets, with internet access and able to understand and answer the survey questionnaires.

排除标准

  • orthopedic limitations, cardiovascular complaints or limitation for performing basic movements

结局指标

主要结局

Quality of sleep

时间窗: 1

Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index

次要结局

  • Mobility(2)

研究者

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

Nereida Kilza da Costa Lima

MD, PhD

University of Sao Paulo

研究点 (2)

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