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

NCT ID: NCT05991505

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-11-30

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.

Conditions

Aging Well; Training Group, Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1- Control

Volunteers with no physical activity during 10 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

2 - Training

Volunteers with supervised home physical activity, twice a week, during 10 weeks

Group Type: ACTIVE_COMPARATOR

Physical exercise

Intervention Type: OTHER

Multimodal exercises twice a week

Interventions

Physical exercise

Multimodal exercises twice a week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Nereida Kilza da Costa Lima

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julio C Moriguti, MD, PhD

Role: STUDY_CHAIR

Ribeirão Preto Medical School - USP

Locations

Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

5174

Identifier Type: -

Identifier Source: org_study_id