NCT04868136

Brief Summary

This randomized cross-over study compares two identical cardiorespiratory exercise bouts, differing only in the inclusion or exclusion of a dynamic period of increasing exercise intensity prior to the exercise bout. Planned comparisons include physiological responses and perceived effort during exercise, leukocyte mobilization, and mood between the two exercise sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

April 25, 2021

Last Update Submit

May 16, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Heart rate during exercise

    Heart rate in beats per minute

    Minutes 1-30 of exercise, recordings made each minute

  • Perceived exertion during exercise

    Rating of perceived exertion measured using the Borg 6-20 scale

    Minutes 1-30 of exercise, recordings made each minute

  • Power during exercise

    Wattage produced on stationary bicycle

    Minutes 1-30 of exercise, recordings made each minute

  • Monocyte mobilization by exercise

    Number of peripheral blood monocytes

    Change from resting levels of monocytes after exercise

  • Natural Killer cell mobilization by exercise

    Number of peripheral blood natural killer cells

    Change from resting levels of natural killer cells after exercise

  • CD4 T cell mobilization by exercise

    Number of peripheral blood CD4 T cells

    Change from resting levels of CD4 T cells after exercise

  • CD8 T cell mobilization by exercise

    Number of peripheral blood CD8 T cells

    Change from resting levels of CD8 T cells after exercise

Secondary Outcomes (2)

  • Mood after exercise

    Measured within 10 minute of end of exercise session

  • Affect after exercise

    Measured within 10 minute of end of exercise session

Study Arms (2)

Warm-up, then no warm-up

EXPERIMENTAL

Participants' visit 2 included 10 minutes of gradually increasing intensity prior to the 30 minute exercise session. Participants' visit 3 consisted of the 30 minute exercise session without a warm-up.

Behavioral: Exercise

No warm-up, then warm-up

EXPERIMENTAL

Participants' visit 2 consisted of the 30 minute exercise session without a warm-up. Participants' visit 3 included 10 minutes of gradually increasing intensity prior to the 30 minute exercise session.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

30 minutes of exercise at 80% of maximum predicted heart rate performed on an indoor stationary bicycle. Exercise was preceded by 10 min of gradually increasing cycling intensity in one of two exercise trials

Also known as: Cardiorespiratory exercise
No warm-up, then warm-upWarm-up, then no warm-up

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • identifies as exercising 1-3 hours per week or more than 6 hours per week, on average (last 6 months)
  • meets American College of Sports Medicine criteria for participation in exercise

You may not qualify if:

  • underlying medical problems that contraindicate supervised high intensity exercise
  • past or present history of autoimmune disease, HIV, hepatitis, stroke, or cardiovascular disease
  • chronic/debilitating arthritis
  • central or peripheral nervous disorders
  • asthma, emphysema, or bronchitis
  • bedridden in the past three months
  • history of blood clotting disorders
  • administration of any medication that might affect physiological response to exercise
  • functional or cognitive impairment that would limit exercise performance or prohibit informed consent
  • having any common-cold or influenza like symptoms (scratchy throat, runny nose, inflamed sinuses, frequent sneezing or coughing) in the last 2 weeks
  • pregnancy
  • tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emily C LaVoy, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized cross-over study with two conditions. Randomization was stratified by sex
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Profesor

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 30, 2021

Study Start

July 15, 2018

Primary Completion

February 1, 2020

Study Completion

September 30, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

All individual participant data that underlie results in a publication will be made available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Will be available upon publication
Access Criteria
Requests should be sent to and will be reviewed by the principle investigator

Locations