Effects of whole body vibration and core exercise on muscle soreness and performance during a foot march

ISRCTN	ISRCTN12264516
DOI	https://doi.org/10.1186/ISRCTN12264516

Submission date: 15/10/2020
Registration date: 16/10/2020
Last edited: 17/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Kaitlin Lyons
Scientific

301 Wire Road
Auburn
36849
United States of America

ORCID ID	0000-0001-9579-1498
Phone	+1 334-844-4483
Email	kdm0031@auburn.edu

Study information

Study design	Single-centre randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	No participant information sheet available
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
Study objectives	Core exercises and whole body vibration is superior to increasing performance and reducing muscle soreness following a foot march
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2019
Completion date	31/12/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	36
Key inclusion criteria	1. Aged 19-35 years
Key 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
Date of first enrolment	15/07/2019
Date of final enrolment	30/11/2019

Locations

Countries of recruitment

United States of America

Study participating centre

Auburn University

301 Wire Road
Auburn
36849
United States of America

Sponsor information

Auburn University
University/education

115 Ramsay Hall
Auburn
36849
United States of America

Phone	+1 3348445966
Email	irbadmin@auburn.edu
Website	http://www.auburn.edu/
"ROR"	https://ror.org/02v80fc35

Funders

Funder type

University/education

Warrior Research Center

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		07/05/2021	17/11/2023	Yes	No

Editorial Notes

17/11/2023: Publication reference added.
16/10/2020: Trial’s existence confirmed by Auburn University IRB.