Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/03/2018
Date assigned
17/04/2018
Last edited
17/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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Subjects were then screened for exclusion criteria such as cardiovascular diseases and four subjects were withdrawn from the study.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

Sponsor information

Organisation

None

Sponsor details

NA
NA
NA
United States of America

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes