Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-12 @ 12:01 AM
Study NCT ID:
NCT05991505
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of sleep', 'timeFrame': '1', 'description': 'Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index'}], 'secondaryOutcomes': [{'measure': 'Mobility', 'timeFrame': '2', 'description': 'Mobility evaluated by Timed up and Go Test and walking speed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging Well', 'Training Group, Sensitivity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPhysical 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.\n\nSleep 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.\n\nSubjects 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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.\n\n\\-\n\nExclusion Criteria:orthopedic limitations, cardiovascular complaints or limitation for performing basic movements\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05991505', 'briefTitle': 'Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women', 'orgStudyIdInfo': {'id': '5174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1- Control', 'description': 'Volunteers with no physical activity during 10 weeks'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 - Training', 'description': 'Volunteers with supervised home physical activity, twice a week, during 10 weeks', 'interventionNames': ['Other: Physical exercise']}], 'interventions': [{'name': 'Physical exercise', 'type': 'OTHER', 'description': 'Multimodal exercises twice a week', 'armGroupLabels': ['2 - Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Julio C Moriguti, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ribeirão Preto Medical School - USP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Nereida Kilza da Costa Lima', 'investigatorAffiliation': 'University of Sao Paulo'}}}}