- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05991505
Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14048900
- Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1- Control
Volunteers with no physical activity during 10 weeks
|
|
Active Comparator: 2 - Training
Volunteers with supervised home physical activity, twice a week, during 10 weeks
|
Multimodal exercises twice a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of sleep
Time Frame: 1
|
Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index
|
1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility
Time Frame: 2
|
Mobility evaluated by Timed up and Go Test and walking speed
|
2
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Julio C Moriguti, MD, PhD, Ribeirão Preto Medical School - USP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging Well
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
Zhangzhou University ChinaCompletedQuality of Life | Well Aging | Aging Well | Well-Being, PsychologicalChina
-
University of West AtticaNot yet recruiting
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
Laval UniversityUniversité Catholique de LouvainRecruitingAging | Older Adults | Aging WellCanada
-
National Hellenic Research FoundationTheracell Advanced BiotechnologyCompletedAging | Oxidative Stress | Well AgingGreece
-
TOPMEDConseil de recherches en sciences naturelles et en génie du Canada; SEC Fonds... and other collaboratorsRecruiting
-
National Institute of Rehabilitation, MexicoNot yet recruiting
-
Adly A AdamCompleted
-
TOPMEDConseil de recherches en sciences naturelles et en génie du Canada; SEC Fonds...Recruiting
Clinical Trials on Physical exercise
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
Instituto de Cardiologia do Rio Grande do SulFundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, BrazilTerminatedObesity | Sedentary Lifestyle | Hypercholesterolemia | High Blood PressureBrazil
-
Universidade Estadual da ParaibaUniversity of Campinas, BrazilUnknown
-
Clarice Maria de Lucena MartinsCompletedMetabolic Diseases | Physical Activity
-
Cardiff UniversityCompletedParkinson's DiseaseUnited Kingdom
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
McGill UniversityUniversité du Québec à Trois-Rivières; Université de Montréal; Concordia University... and other collaboratorsRecruiting
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Universidad Católica San Antonio de MurciaCompleted
-
The Hong Kong Polytechnic UniversityUniversity of Santo TomasUnknownMild Cognitive ImpairmentPhilippines