NCT05991505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

August 7, 2023

Last Update Submit

August 7, 2023

Conditions

Aging WellTraining Group, Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Quality of sleep

    Quality of sleep evaluated by actigraphy and Pittsburgh Sleep Quality Index

    1

Secondary Outcomes (1)

  • Mobility

    2

Study Arms (2)

1- Control

NO INTERVENTION

Volunteers with no physical activity during 10 weeks

2 - Training

ACTIVE COMPARATOR

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

Other: Physical exercise

Interventions

Physical exerciseOTHER

Multimodal exercises twice a week

2 - Training

Eligibility Criteria

Age60 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Julio C Moriguti, MD, PhD

    Ribeirão Preto Medical School - USP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 14, 2023

Study Start

February 1, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

BR(1)