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Water Exercise and Vascular Function in Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yula Pires da Silveira Fontenele de Meneses, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier:
NCT01642654
First received: July 10, 2012
Last updated: July 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Elderly Women
 Other: Exercise
Other: Educational lectures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nitrite Levels and Vascular Function in Elderly Women Submitted to Water Exercise: a Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal do Rio Grande do Norte:

Primary Outcome Measures:
  • Determining modifications caused by this program on plasma nitrite concentration (NO3). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cerebral artery assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Other: Educational lectures
Educational lectures
Experimental: Treatment Other: Exercise
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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642654

Locations
Brazil
Universidade Estadual do Piauí
Teresina, PI, Brazil
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
Study Chair: Arméle Dornelas Universidade Federal de Pernambuco
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Yula Pires da Silveira Fontenele de Meneses, Msc, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT01642654     History of Changes
Other Study ID Numbers: yula01
Study First Received: July 10, 2012
Last Updated: July 16, 2012
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on May 22, 2013