NCT03609957

Brief Summary

Non-Hispanic Blacks tend to report higher levels of pain, experience pain more frequently, and be under-treated for pain compared to non-Hispanic Whites. Acute (single session) exercise is known to be effective at reducing pain but it is unknown what effect chronic exercise training has on pain responses. The broad goal of this study is to determine whether regular exercise training is more effective at reducing pain responses in non-Hispanic Blacks compared to non-Hispanic Whites. The investigators are interested in comparing regular aerobic exercise training versus high-intensity interval training.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 11, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

July 11, 2018

Last Update Submit

December 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in skin blood flow response to local heating

    Vasodilation in response to painful and non-painful heating of the skin

    Baseline (prior to intervention or control) and at the conclusion of the 5-week intervention or control. The post-intervention assessment will be performed no later than 3-5 days after completion of the 5-week intervention or control.

Study Arms (3)

Aerobic Exercise Training

EXPERIMENTAL

Moderate intensity (75% heart rate reserve) cycling exercise for 32 minutes, 3 days per week for 5 weeks

Other: Aerobic Exercise Training

Interval Training

EXPERIMENTAL

High intensity (95% heart rate reserve) cycling exercise for 20 minutes, 3 days per week for 5 weeks

Other: Interval Training

Control

NO INTERVENTION

Control (no exercise intervention) group

Interventions

Traditional, continuous aerobic exercise (cycling) at a moderate intensity

Aerobic Exercise Training

High-intensity interval exercise consisting of short bursts of exercise interspersed with rest periods

Interval Training

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Normotensive
  • Identify as non-Hispanic Black or non-Hispanic White
  • Healthy enough to participate in regular exercise
  • Not taking any medications other than birth control

You may not qualify if:

  • Heart disease (high blood pressure, previous stroke or heart attack)
  • Type 1 or 2 diabetes
  • History of cancer treated with chemotherapy
  • History of nerve damage
  • History of chronic pain
  • Current smoker/tobacco user or quit less than 1 year ago
  • Skin disorders (psoriasis, etc.)
  • Pregnant
  • Taking any medications other than birth control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (44)

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MeSH Terms

Conditions

Acute PainNeuralgiaAgnosia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Brett J Wong, Ph.D.

    Georgia State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

August 1, 2018

Study Start

February 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 11, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

The current approved IRB and informed consent state that we will not share participants' data except with applicable oversight bodies (IRB, FDA, OHRP, etc.).

Locations