NCT05658224

Brief Summary

We will investigate the effects of the length of education on exercise-induced hypoalgesia (EIH). Two previous studies have shown that positive education about the effects of exercise and the phenomena of EIH produce enhancements to EIH response (having decreased reports of pain with exercise). These previous studies used different amounts of education time, this study will compare directly if the length of education time varies the effects on EIH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 30, 2022

Results QC Date

June 4, 2024

Last Update Submit

November 21, 2024

Conditions

Keywords

Exercise induced hypoalgesiaEducation

Outcome Measures

Primary Outcomes (1)

  • Pain Pressure Threshold

    Measurement in kg/cm2, higher score is better outcome

    3 minutes post exercise on Day following educational session and exercise

Secondary Outcomes (1)

  • Knowledge and Beliefs About Exercise and Pain Questionnaire

    3 minutes post exercise on Day following educational session and exercise

Study Arms (2)

Short education

ACTIVE COMPARATOR

Individuals receiving a short (1-minute) educational session on exercise-induced hypoalgesia

Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise

Long education

ACTIVE COMPARATOR

Individuals receiving long (10-15 minutes) educational session on exercise-induced hypoalgesia

Behavioral: Education on effects of Exercise-induced hypoalgesia from exercise

Interventions

Educational session with participants

Long educationShort education

Eligibility Criteria

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

You may qualify if:

  • Able to read and understand English,
  • Refrained from alcohol, pain medication, and vigorous exercise for the past 24 hours,
  • No history of chronic pain (pain \> 3 months), or current pain/injury that would prevent the ability to do exercise.

You may not qualify if:

  • unable to meet screening questions for PAR-Q+ for safe exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Dakota

Vermillion, South Dakota, 57069, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Kory Zimney
Organization
USouthDakota

Study Officials

  • Kory Zimney, DPT, PT

    University of South Dakota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be randomized into 1 of 2 groups. Outcome assessor will not be informed of participant grouping.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 20, 2022

Study Start

November 1, 2022

Primary Completion

February 15, 2023

Study Completion

May 1, 2023

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

upon request

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Upon completion of study for 3 years after closing study.
Access Criteria
email PI at kory.zimney@usd.edu for data

Locations