Condition category
Musculoskeletal Diseases
Date applied
15/10/2020
Date assigned
16/10/2020
Last edited
16/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Approximately 25% of injuries to United States Infantry and Initial Entry Training (IET) soldiers are due to foot marches, an important military task. Back injuries are one of the most common musculoskeletal injuries resulting from foot marching, accounting for 27% of all foot march injuries. The aim of this study is to evaluate the effect of Core Exercise and Whole Body Vibration on low back pain and performance during a foot march.

Who can participate?
Healthy volunteers aged 19-35 years.

What does the study involve?
Participants will be asked to complete two 8 km foot marches carrying a 35 lbs rucksack, four weeks apart. Participants in the core exercise and whole body vibration with core exercise groups will be asked to complete core exercises three times a week for three week between foot marches. Before, during, after, 1 day and 2 days after completing the foot march low back pain/soreness, performance, muscle oxygenation, .biomarkers via blood draws, muscle activation, posture and exertional levels will be measured.

What are the possible benefits and risks of participating?
There are no direct benefits to the participants. The risk of participating include risk of falling or injury from the whole body vibration platform, risk of dizziness, nausea, headache or vomiting from the whole body vibration platform, risk of pain, redness, swelling, infection, bruising and fainting from the blood draw, risk of muscle soreness, pain or injury from completing the foot march, risk of breach of confidentiality, and a risk of a rash from the adhesive material used to attached EMG sensors to the skin.

Where is the study run from?
Auburn University (USA)

When is the study starting and how long is it expected to run for?
From June 2019 to December 2019

Who is funding the study?
Warrior Research Center (USA)

Who is the main contact?
Kaitlin Lyons
kdm0031@auburn.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kaitlin Lyons

ORCID ID

http://orcid.org/0000-0001-9579-1498

Contact details

301 Wire Road
Auburn
36849
United States of America
+1 334-844-4483
kdm0031@auburn.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effects of a whole body vibration and core exercise intervention on muscle soreness and performance during a foot march: a randomized controlled trial

Acronym

Study hypothesis

Core exercises and whole body vibration is superior to increasing performance and reducing muscle soreness following a foot march

Ethics approval

Approved 14/07/2019, Auburn University Institutional Review Board (115 Ramsay Hall, Auburn, AL 36849; IRBADMIN@auburn.edu; +1 334-844-5966), ref: 19-211

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Low back pain

Intervention

Study volunteers will be randomly allocated by the researchers, using a random number generator, into one of three groups:
1. Whole body vibration with core exercise
2. Core exercise only
3. Control group.

All participants will be asked to complete an 8 km foot march. Following the completion of the foot march and a one week wash-out period, participants in the whole body vibration with exercise and core exercise groups will complete three weeks of core exercise training with or without whole body vibration. Core exercise training with or without whole body vibration will occur for 20 mins, three times per week. The control group will continue with their normal activity. Following three weeks of training, all participants will be asked to complete a second 8 km foot march. During the foot march participants will be asked to carry a 35 lb military rucksack, packed by an Army Officer, as fast as they can safely complete the 8 km distance.

Before, during, and after each foot march participant's low back pain/soreness, posture, muscle oxygenation, muscle activation, exertion level, blood biomarkers for muscle soreness/damage and performance will be assessed. Demographic information including age, height, and weight will also be collected using a questionnaire.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Low back pain measured using a visual analog scale before, half-way through, immediately after, and 1 day and 2 days following each foot march at 0 and 3 weeks
2. Low back soreness measured using an algometer before, immediately after, and 1 day and 2 days following each foot march at 0 and 3 weeks

Secondary outcome measures

1. Performance measured as time to complete the 8 km distance measured at the completion of the foot march at 0 and 3 weeks
2. Muscle Damage measured from blood draws taken before, half-way through, immediately after, and 1 day and 2 days following each foot march at 0 and 3 weeks
3. Muscle Activation measured with surface electromyography (EMG) sensors during the foot march at 0 and 3 weeks
4. Exertion Level measured with Borg rating of perceived exertion scal before, half-way through, immediately after, and 1 day and 2 days following each foot march at 0 and 3 weeks
5. Muscle Oxygenation measured with Humon Hex device (worn on the upper thigh), before, half-way through, immediately after, and 1 day and 2 days following each foot march at 0 and 3 weeks
6. Posture measured with a Zephyr Bioharness (worn around the chest), before, half-way through, immediately after, and 1 day and 2 days following each foot march at 0 and 3 weeks

Overall trial start date

01/06/2019

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 19-35 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

1. Acute inflammation and infections
2. Acute joint disorders or arthroses
3. Chronic migraine headaches
4. Cardiovascular diseases, such as heart and vascular
5. Recent joint implants such as foot, knee, and implants
6. Heart rhythms or valve disorders
7. Recently placed metal or synthetic implants such as pacemakers and cochlear implants
8. Pregnancy, gallstones, or epilepsy
9. Recent thrombosis or possible thrombotic complaints
10. Tumors, diabetes, or kidney stones
12. Have a current concussion or a concussion within the last 90 days
13. Allergic to adhesives

Recruitment start date

15/07/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

United States of America

Trial participating centre

Auburn University
301 Wire Road
Auburn
36849
United States of America

Sponsor information

Organisation

Auburn University

Sponsor details

115 Ramsay Hall
Auburn
36849
United States of America
+1 3348445966
irbadmin@auburn.edu

Sponsor type

University/education

Website

http://www.auburn.edu/

Funders

Funder type

University/education

Funder name

Warrior Research Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/10/2020: Trial’s existence confirmed by Auburn University IRB.