Water Exercise and Vascular Function in Elderly

Elderly Women Clinical Trial

Official title:

Nitrite Levels and Vascular Function in Elderly Women Submitted to Water Exercise: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642654
• Other study ID #: yula01
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: July 16, 2012
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2012
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly Women

Intervention

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.
• Educational lectures
Educational lectures

Locations

Country	Name	City	State
Brazil	Universidade Estadual do Piauí	Teresina	PI

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining modifications caused by this program on plasma nitrite concentration (NO3).	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.	16 weeks	No
Secondary	Cerebral artery assessment	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.	16 weeks	No

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