NCT01967121

Brief Summary

The purpose of this research study is to determine if the application of ice, control group, or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed muscle soreness from performing leg extension and flexion. Individuals will complete a health history questionnaire to determine if they qualify for this study. We will measure your leg girth with a measuring tape and take a pain measurement of your hamstrings by using a spring to press down on your leg. Individuals will then warm-up on a bike without resistance for 5 minutes followed by 10 regular leg extension and flexion exercises. Individuals will then perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg curl machines in the gym). Individuals will perform each set to the maximum effort of their capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank your leg soreness on a scale from 1-10. Individuals will then be assigned to a modality of either ice, control group or compex. Individuals will perform the modality (ice, control, compex) we assign you to until you are no longer sore. Over the next five days individuals will return to measure their level of soreness, leg girth and pain pressure. This study will examine the following hypotheses: H1: There will be no difference in pressure pain threshold after using the Compex compared to other groups. H2: There will be no difference in perceived soreness after using the Compex compared to other groups. H3: There will be no difference in muscular strength after using the Compex compared to other groups. H4: There will be no difference in active range of motion after using the Compex compared to other groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 29, 2014

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

October 16, 2013

Results QC Date

April 23, 2014

Last Update Submit

August 28, 2014

Conditions

Keywords

Compex, ice

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analog Scale

    Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.

    Day 1 through Day 5

Study Arms (3)

'Compex unit's Active Recovery® program'

EXPERIMENTAL

The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.

Device: Compex unit's Active Recovery® program

Ice application

OTHER

A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).

Other: Ice application

Control

NO INTERVENTION

This is a control group where subjects will not perform an intervention.

Interventions

Compex unit's Active Recovery® program will be performed for 15 minutes once per day.

'Compex unit's Active Recovery® program'

Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present

Ice application

Eligibility Criteria

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

You may qualify if:

  • The studied population will be composed of 45 physically active college students between the ages of 18-30 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Results Point of Contact

Title
Tracey Covassin
Organization
Michigan State University

Study Officials

  • Tracey Covassin, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 22, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 29, 2014

Results First Posted

August 29, 2014

Record last verified: 2014-08

Locations