NCT02876705

Brief Summary

The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise. Participants will perform two constant tests (cycling and running) at an intensity corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e., hard). Using a body map template, participants will report every 15s the perceived locations with discomfort and pain independently of the magnitude of the discomfort and pain.

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 early_phase_1 pain

Timeline
Completed

Started Sep 2016

Shorter than P25 for early_phase_1 pain

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

August 5, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

August 5, 2016

Last Update Submit

October 10, 2016

Conditions

Keywords

PatternsPainCyclingRunningExhaustion

Outcome Measures

Primary Outcomes (1)

  • Changes of pain location during exercise measured through pain drawings, body maps, or manikins.

    We tend to study and delineate individualized pain and discomfort patterns during exercise.

    through study completion, an average of 3 weeks

Study Arms (1)

Pain Patterns

EXPERIMENTAL

In this vein, we tend to study and delineate individualized pain and discomfort patterns in exercise.

Other: Exercise

Interventions

Completion of this study will took a total of three sessions, separated by one-week intervals. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). Participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks. The constant-power cycling and running will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence.

Pain Patterns

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INEFCatalunya

Barcelona, Barcelona, 08038, Spain

Location

MeSH Terms

Conditions

Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Personal Investigator

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 24, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

25th of October 2016, all files will be available from the database https://figshare.com/

Locations