NCT01642654

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.

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 May 2010

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
Last Updated

July 17, 2012

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

July 10, 2012

Last Update Submit

July 16, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cerebral artery assessment

    16 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR
Other: Educational lectures

Treatment

EXPERIMENTAL
Other: Exercise

Interventions

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.

Treatment

Educational lectures

Control

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • subjects with any form of transmittable or uncontrolled disease or insulin-dependent hypertensive;
  • unable to perform functional autonomy tests;
  • women undergo hormonal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual do Piauí

Teresina, Piauí, Brazil

Location

Related 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. doi: 10.1123/japa.13.1.61.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Arméle Dornelas

    Universidade Federal de Pernambuco

    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
Msc

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 17, 2012

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 17, 2012

Record last verified: 2012-03

Locations