ISRCTN ISRCTN17326333
DOI https://doi.org/10.1186/ISRCTN17326333
Secondary identifying numbers 2016.1
Submission date
13/03/2018
Registration date
17/04/2018
Last edited
24/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Dr FB WIllis, MBBS, PhD, FACSM
Public

3433 Cove View Blvd #3517
Galveston
77554
United States of America

Phone 1-409-457-7894
Email DocWillis@yahoo.com

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeTreatment
Participant information sheet ISRCTN17326333_PIS_09Apr18.pdf
Scientific titleBrief, aerobic-surge exercise for weight loss: a preliminary randomized, controlled trial
Study objectivesThe 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(s)McMurry University IRB and Galveston Research IRB, 10/1/2016.
Health condition(s) or problem(s) studiedObesity
InterventionThe 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 typeBehavioural
Primary outcome measureChanges 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 measuresCompliance assessed by weekly communication with participants and measured as the proportion who completed the exercises at least 4 times per day.
Overall study start date01/08/2015
Completion date01/05/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants50
Key inclusion criteria1. BMI >30 kg/m2
2. Aged 18-65 years
Key exclusion criteria1. 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
Date of first enrolment15/01/2016
Date of final enrolment15/06/2016

Locations

Countries of recruitment

  • United States of America

Study participating centre

Galveston Clinical Research
6341 Stewart RD #115
Galveston
77551
United States of America

Sponsor information

None
Not defined

NA
NA
NA
United States of America

Funders

Funder type

Not defined

NONE

No information available

Results and Publications

Intention to publish date20/06/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPreparing for submission to "BMC Sports Science, Medicine and Rehabilitation"
IPD sharing planAs 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2018 Yes No
Participant information sheet 09/04/2018 17/04/2018 No Yes

Additional files

ISRCTN17326333_PIS_09Apr18.pdf
Uploaded 17/04/2018

Editorial Notes

24/04/2019: Internal review.
04/01/2019: Publication reference added.