NCT00001519

Brief Summary

Measurements of dynamic changes in oxygen uptake (VO2 kinetics) during recovery from exercise may describe regulatory control of oxygen transport and utilization and have greater reliability and less inherent risk than assessment of maximal oxygen uptake (VO2max) in patients for whom exercise is limited by pain, excessive fatigue, dyspnea and motivation. The purpose of this pilot study is to evaluate the effect of exercise intensity on the time constant describing changes in VO2 (tauVO2) during recovery from one minute of constant work rate exercise. Five normal healthy volunteers ages 18 and older will perform a progressive maximal aerobic exercise test, using a cycle ergometer, to determine VO2max and lactate threshold (LT) estimated by gas exchange. Each subject will also complete a series of maximal constant work rate tests and submaximal constant work rate tests at 80% LT and 50% of the difference between LT and VO2max (50% delta). Breath by breath variability and VO2 span will be used to determine the number of constant work rate test repetitions, for each subject for each exercise intensity, needed to establish confidence in tauVO2. A mean response profile of VO2 recovery kinetics for each exercise intensity will be analyzed using non-linear regression to determine tauVO2. To examine the effect of exercise intensity on tauVO2, one way analysis of variance will be used to determine whether differences exist among maximal and submaximal (80% LT and 50% delta) time constants. We hypothesize that there will be no significant differences among time constants for VO2 during recovery from maximal and submaximal constant work rate exercise lasting one minute. The results of this study are expected to provide increased understanding of the measurement of VO2 kinetics during recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 1996

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

ExerciseExercise IntensityNon-Linear RegressionOxygen UptakeRecoverySubject ComparisonTime ConstantVO2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Normal healthy subjects ages 18 and older.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Sietsema KE, Cooper DM, Perloff JK, Rosove MH, Child JS, Canobbio MM, Whipp BJ, Wasserman K. Dynamics of oxygen uptake during exercise in adults with cyanotic congenital heart disease. Circulation. 1986 Jun;73(6):1137-44. doi: 10.1161/01.cir.73.6.1137.

    PMID: 3698248BACKGROUND
  • Hughson RL. Alterations in the oxygen deficit-oxygen debt relationships with beta-adrenergic receptor blockade in man. J Physiol. 1984 Apr;349:375-87. doi: 10.1113/jphysiol.1984.sp015161.

    PMID: 6429319BACKGROUND
  • Powers SK, Dodd S, Beadle RE. Oxygen uptake kinetics in trained athletes differing in VO2max. Eur J Appl Physiol Occup Physiol. 1985;54(3):306-8. doi: 10.1007/BF00426150.

    PMID: 4065115BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

June 1, 1996

Study Completion

April 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-05

Locations