NCT01341145

Brief Summary

The goal of this study is to determine if aerobic exercise or progressive muscle relaxation is associated with changes in cardiovascular health, brain function, and cognition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable hypertension

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

3.1 years

First QC Date

March 30, 2011

Last Update Submit

April 10, 2014

Conditions

Hypertension

Keywords

hypertensionaerobic exerciserelaxationfunctional magnetic resonance imaging (fMRI)magnetic resonance spectroscopy (MRS)brain health

Outcome Measures

Primary Outcomes (2)

  • Percent signal change in Blood oxygen level-dependent (BOLD) response to a working memory task

    Blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) during 2-Back working memory task

    change from baseline in blood oxygen level-dependent (BOLD) response to WM task at 14 weeks

  • N-acetyl aspartate (NAA) concentration

    Magnetic resonance spectroscopy (MRS) measurements of N-acetyl-aspartate (NAA)

    change from baseline in N-acetyl aspartate (NAA) concentration at 14 weeks

Study Arms (2)

Aerobic Exersice

EXPERIMENTAL

12-week moderate aerobic exercise program

Behavioral: Aerobic Exercise

Relaxation

ACTIVE COMPARATOR

12-week at home progressive muscle relaxation program

Behavioral: Relaxation

Interventions

Aerobic ExerciseBEHAVIORAL

12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine

Also known as: Exercise
Aerobic Exersice
RelaxationBEHAVIORAL

12-week progressive muscle relaxation program (active control)

Relaxation

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary adults Participants will be classified as sedentary if they have not engaged in regular physical exercise for at least one year prior to study enrollment.
  • Ages 45-65
  • Normal blood pressure or Borderline or stage 1 hypertension Borderline hypertension will be defined as systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg. Stage 1 hypertension will be defined as systolic blood pressure between 140-159 mmHg and/or diastolic blood pressure between 90-99 mmHg.

You may not qualify if:

  • Signs or symptoms of chronic heart disease
  • Smoking (current or within the past 6 months)
  • Peripheral artery disease (ankle-brachial index\<0.9)
  • Diabetes (fasting blood glucose\>126 mg/L)
  • Orthopedic problems that would prohibit participants from participating in exercise.
  • Axis I psychiatric disorder
  • Magnetic resonance contraindications
  • Baseline Intellectual Quotient \< 70
  • Below chance performance on the practice items of the cognitive tasks
  • Evidence of large vessel stroke on magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Andreana Haley, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

  • Hirofumi Tanaka, Ph.D.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 25, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

US(1)