- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642654
Water Exercise and Vascular Function in Elderly
Nitrite Levels and Vascular Function in Elderly Women Submitted to Water Exercise: a Randomised Controlled Trial
Objectives:
The purpose of this research was to assess modifications caused by a concurrent water exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in the elderly and analyze the correlations between these variables after intervention.
Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to determine the resistivity index and Cholesterol was determined using the colorimetric enzymatic method and test kit. Intervention with water exercise program consisted of three weekly sessions for 16 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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PI
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Teresina, PI, Brazil
- Universidade Estadual do PiauÍ
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- older than 60 and lass than 80 years age;
- the elderly should be independent in their ADLs;
- be considered able for medical evaluation to participate in the intervention and testing protocols;
- still not be participating in regular systematized physical activity for at least six months.
Exclusion Criteria:
- subjects with any form of transmittable or uncontrolled disease or insulin-dependent hypertensive;
- unable to perform functional autonomy tests;
- women undergo hormonal replacement therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Control
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Educational lectures
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EXPERIMENTAL: Treatment
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The WG was submitted to a 16-week WEP, with combined aerobic and resistance exercises in three weekly sessions.
Water temperature was approximately 30º C with an average ambient temperature of 34° C. The pool had water levels ranging between 1,20 and 1,40 meters deep.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determining modifications caused by this program on plasma nitrite concentration (NO3).
Time Frame: 16 weeks
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For NO analysis, serum was separated from the erythrocyte mass.
The material was centrifuged in a SIGMA 4k15 centrifuge at 3500 rpm and 18° for 10 minutes (LANEX laboratory- UFPI); the serum was then pipetted and frozen at 80° for evaluation after retesting (16 weeks).
NO production was determined based on NO3 in the supernatant of cultured cells, an indirect measurement of NO synthesis.
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cerebral artery assessment
Time Frame: 16 weeks
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Carotid and vertebral arteries were assessed by Doppler ultrasound, with GE Logiq 5 equipment and multi-frequency linear transducer (Milwaukee - UEA).
Parameters used were evaluation of peak systolic velocity and end-diastolic velocity of the common carotid and left and right internal carotids, with the angle of insonation corrected to 60°.
The resistivity index of arteries was calculated, resulting from the mathematical formula in centimeters per second (cm/s): Resistivity index = Peak systolic velocity - End-diastolic velocity / Peak systolic velocity.
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16 weeks
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Collaborators and Investigators
Investigators
- Study Chair: Arméle Dornelas, Universidade Federal de Pernambuco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- yula01
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.
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