Plain English Summary
Background and study aims
Over 70% of US population are overweight, and almost 40% are categorically obese based on body mass index (BMI). There are numerous programs, diets, and exercise regimes, but these are inadequate because obesity continues to rise. The purpose of this study is to determine if a unique 2-minute Energy-surge exercise routine (performed five times/day) is effective in reduced subjects’ weight and girth sizes.
Who can participate?
Healthy adults aged 18-65 years who are obese (have a BMI of 30 or more).
What does the study involve?
Healthy obese subjects were randomly assigned to the Experimental or Control groups. Experimental group participants were taught how to make many movements such as riding a stationary bicycle or lifting dumbbells into an ‘Aerobic-surge’ exercise at or above 75% of calculated maximum heart rate. They were taught to perform these exercises for 2 minutes 5 times per day. Control subjects were simply told to exercise more. No dietary changes were made for either group.
What are the possible benefits and risks of participating?
The potential risks included joint injuries from exercise or falling and worsening of undiagnosed heart problems. The potential benefits included decreased weight and body size, improved appearance and self esteem, decreased hypertension and disease, and increased ability to perform activities of daily living.
Where is the study run from?
Participants were screened, trained and measured in Galveston, TX. They did the exercises at home.
When is the study starting and how long is it expected to run for?
Who is funding the study?
There is no external funding for the study.
Who is the main contact?
Dr FB Willis, DocWillis@yahoo.com
After being briefed on the study, Subjects: Fifty four adults were recruited for this study in Austin, Abilene, and Galveston Texas, USA. All subjects understood and completed written informed consent as required by the IRBs.
Subjects were then screened for exclusion criteria such as cardiovascular diseases and four subjects were withdrawn from the study. The remaining were were randomly categorized as Experimental (N=25 receiving treatment) or Control (N=25).
After being weighed, measurements of ten body circumferences were measured (neck, chest , waist hip, etc,). Experimental subjects were taught how to perform an "Aerobic-surge" exercise at 75% of their calculated maximum heart rate with different exercises (climbing stairs, stationary bicycle riding, etc.). They were instructed to perform this Aerobic-surge five times/day in this 60-day study.
Joint injuries from exercise or falling
Exacerbation of undiagnosed cardiac anomalies
4.2 Potential Benefits
Decreased weight and body mass
Increased appearance and self esteem
Decreased hypertension and disease
Increased activities of daily living
Trial website
Contact information
Type
Public
Primary contact
Dr Dr FB WIllis, MBBS, PhD, FACSM
ORCID ID
Contact details
3433 Cove View Blvd #3517
Galveston
77554
United States of America
1-409-457-7894
DocWillis@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2016.1
Study information
Scientific title
Brief, aerobic-surge exercise for weight loss: a preliminary randomized, controlled trial
Acronym
Study hypothesis
The purpose of this current study was to determine if a frequent, high intensity, 2-minute aerobic-surge exercise routine (5/day) was effective in reducing subjects’ weight and girth sizes.
Ethics approval
McMurry University IRB and Galveston Research IRB, 10/1/2016.
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
See additional files
Condition
Obesity
Intervention
The participants were randomly categorized as Experimental (N=25 receiving treatment) or Control (N=25). After being weighed, measurements of ten body circumferences were taken. Experimental subjects were taught how to perform an "Aerobic-surge" exercise at 75% of their calculated maximum heart rate with different exercises (including supine scissor kicks, running in place, stationary bicycling, jumping jacks, biceps curls, triceps extensions, medicine ball swings, climbing stairs, etc). They were instructed to perform this Aerobic-surge for 2 minutes five times/day in this 60-day study. (The goal for Energy-surge was 5/day but 4/day completion was expected.)
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Changes in weight and body circumferences (neck, shoulders, chest, upper arm, lower arm, wrist, waist, hips, upper thigh, above knee, calf, ankle). The weight and body circumferences were measured at enrollment and after 60 days (+/-5 days) by the same research assistant under the supervision of the principal investigator.
Secondary outcome measures
Compliance assessed by weekly communication with participants and measured as the proportion who completed the exercises at least 4 times per day.
Overall trial start date
01/08/2015
Overall trial end date
01/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. BMI >30 kg/m2
2. Aged 18-65 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Cerebrovascular accident or traumatic brain injury
2. Cardiovascular pathologies, including uncontrollable hypertension, atrial fibrillation and history of myocardial infarction
3. Rheumatoid arthritis
4. Pregnancy
5. Hypothyroid secretion
6. Hypogonadal syndrome
7. Diabetes mellitus (type 1 or 2)
8. Other weight loss protocols, diets, or medication
Recruitment start date
15/01/2016
Recruitment end date
15/06/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
Galveston Clinical Research
6341 Stewart RD #115
Galveston
77551
United States of America
Funders
Funder type
Not defined
Funder name
NONE
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Preparing for submission to "BMC Sports Science, Medicine and Rehabilitation"
IPD sharing statement (as of 09/04/2018)
Patient files were lost in the Hurricane Harvey floods but data sets may be acquired by contacting Dr Willis directly for the next 7 years.
Intention to publish date
20/06/2018
Participant level data
Available on request
Basic results (scientific)
Significant changes seen (reductions) in body weight and body circumference measurements, (p<0.0001).
There were no adverse events and upon completion all subjects were again weighed with circumference measurements. Subjects completed a mean 4.2 exercise/day in the 60-day study and there were significant differences in weight and body circumferences (p< 0.0001). The mean differences for Experimental subjects was -18.0 lb (±7) and -18.7 inches (±6). The control subjects mean changes were +1.3 lb (±3), +1.7 inches (±4).
Publication list
2018 results in: http://scivisionpub.com/pdfs/food-allergen-eliminations-for-obesity-reduction-a-comparison-study-with-therapeutic-exercise-580.pdf
Publication citations
Additional files
- ISRCTN17326333_PIS_09Apr18.pdf Uploaded 17/04/2018