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Water Exercise and Vascular Function in Elderly

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ClinicalTrials.gov Identifier: NCT01642654
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Yula Pires da Silveira Fontenele de Meneses, Universidade Federal do Rio Grande do Norte

Tracking Information
First Submitted Date  ICMJE July 10, 2012
First Posted Date  ICMJE July 17, 2012
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE May 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
Determining modifications caused by this program on plasma nitrite concentration (NO3). [ Time Frame: 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
Cerebral artery assessment [ Time Frame: 16 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Water Exercise and Vascular Function in Elderly
Official Title  ICMJE Nitrite Levels and Vascular Function in Elderly Women Submitted to Water Exercise: a Randomised Controlled Trial
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Elderly Women
Intervention  ICMJE
  • 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.
  • Other: Educational lectures
    Educational lectures
Study Arms  ICMJE
  • Active Comparator: Control
    Intervention: Other: Educational lectures
  • Experimental: Treatment
    Intervention: Other: Exercise
Publications * Cress ME, Buchner DM, Prohaska T, Rimmer J, Brown M, Macera C, Dipietro L, Chodzko-Zajko W. Best practices for physical activity programs and behavior counseling in older adult populations. J Aging Phys Act. 2005 Jan;13(1):61-74. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2012)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01642654
Other Study ID Numbers  ICMJE yula01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yula Pires da Silveira Fontenele de Meneses, Universidade Federal do Rio Grande do Norte
Study Sponsor  ICMJE Universidade Federal do Rio Grande do Norte
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Arméle Dornelas Universidade Federal de Pernambuco
PRS Account Universidade Federal do Rio Grande do Norte
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP