NCT02408614

Brief Summary

The study objectives are the following: 1) To examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) To examine the influence of age and gender on these responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

March 31, 2015

Last Update Submit

January 23, 2019

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Change in vascular endothelial function

    Brachial artery endothelium-dependent flow-mediated dilation to reactive hyperemia will be measured using high resolution ultrasonography. Brachial artery diameter and blood velocity will be measured before and after occluding the forearm for 5 minutes by inflating a cuff to 250 mmHg.

    Baseline, 15 minutes after exercise and 1 hour after exercise

Secondary Outcomes (1)

  • Change in arterial stiffness

    Baseline, 15 minutes after exercise and 1 hour after exercise

Study Arms (3)

Slow-paced walking

Subjects will complete 47 minutes of walking at slow pace.

Other: Slow-paced walkingDevice: Treadmill

Moderate-paced walking

Subjects will complete 47 minutes of walking at a moderate pace.

Other: Moderate-paced walkingDevice: Treadmill

Interval training

Subjects will complete 40 minutes of walking alternating between a moderate and fast pace.

Other: Interval TrainingDevice: Treadmill

Interventions

Slow-paced walkingOTHER

Subjects will complete 47 minutes of walking on a treadmill at a slow-pace.

Slow-paced walking
Moderate-paced walkingOTHER

Subjects will complete 47 minutes of walking on a treadmill at a moderate pace.

Moderate-paced walking
Interval TrainingOTHER

Subjects will complete 40 minutes of walking on the treadmill alternating between a moderate and a fast pace.

Interval training
TreadmillDEVICE
Interval trainingModerate-paced walkingSlow-paced walking

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population including men and women 18 to 79 years of age

You may qualify if:

  • Men and women 18 to 79 years of age
  • Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years.
  • Premenopausal women will be eumenorrheic.
  • Able to give consent.

You may not qualify if:

  • History of hepatic disease or infection with hepatitis B, C or HIV
  • History of other relevant on-going or recurrent illness
  • Recent (within 3 months) or recurrent hospitalizations
  • Current intake of medications that may affect study results
  • Use of tobacco products
  • Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
  • Pregnancy (positive urine pregnancy test) or lactation
  • Perimenopausal women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Cardiovascular Physiology Laboratory

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

High-Intensity Interval TrainingExercise Test

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Demetra Christou, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

June 1, 2015

Primary Completion

January 23, 2019

Study Completion

January 23, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

US(1)