Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women
Primary Purpose
Aging Well, Training Group, Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Aging Well
Eligibility Criteria
Inclusion Criteria: 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. - Exclusion Criteria:orthopedic limitations, cardiovascular complaints or limitation for performing basic movements -
Sites / Locations
- Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1- Control
2 - Training
Arm Description
Volunteers with no physical activity during 10 weeks
Volunteers with supervised home physical activity, twice a week, during 10 weeks
Outcomes
Primary Outcome Measures
Quality of sleep
Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index
Secondary Outcome Measures
Mobility
Mobility evaluated by Timed up and Go Test and walking speed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05991505
Brief Title
Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women
Official Title
Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Well, Training Group, Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1- Control
Arm Type
No Intervention
Arm Description
Volunteers with no physical activity during 10 weeks
Arm Title
2 - Training
Arm Type
Active Comparator
Arm Description
Volunteers with supervised home physical activity, twice a week, during 10 weeks
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
Multimodal exercises twice a week
Primary Outcome Measure Information:
Title
Quality of sleep
Description
Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index
Time Frame
1
Secondary Outcome Measure Information:
Title
Mobility
Description
Mobility evaluated by Timed up and Go Test and walking speed
Time Frame
2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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.
-
Exclusion Criteria:orthopedic limitations, cardiovascular complaints or limitation for performing basic movements
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio C Moriguti, MD, PhD
Organizational Affiliation
Ribeirão Preto Medical School - USP
Official's Role
Study Chair
Facility Information:
Facility Name
Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048900
Country
Brazil
12. IPD Sharing Statement
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Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women
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