Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05991505 |
| Other study ID # |
5174 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
University of Sao Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
