Severe Obesity Clinical Trial
Official title:
Adherence to Walking on an Alter G Anti-Gravity Treadmill
Verified date | October 2018 |
Source | Texas Tech University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Several barriers to exercise are present that need to be addressed. Morbidly obese
individuals experience more skin friction, urinary stress incontinence, knee pain, low back
pain, and hip arthritis than the lean population, which may significantly impair their
ability to adhere to an exercise regimen (6). Obesity and overweight also contribute to
greater perceived effort, oxygen uptake, and less pleasure during treadmill exercise sessions
(7). Recent theories suggest that a negative experience associated with exercise can
significantly reduce the likelihood of engaging in future exercise sessions (8). Therefore,
tools to reduce these barriers may improve outcomes for exercise-based interventions for
morbid obesity.
The Alter-G, an antigravity treadmill that alleviates body weight while subjects exercise,
has potential to reduce pain and exertion during exercise. Overall, these treadmills have
been found to be effective for weight loss in obese populations (10). However, although
evidence suggests that the Alter-G would reduce pain and exertion, the effect of the Alter-G
treadmill on exercise adherence in morbidly obese populations has not been studied.
The hypothesis is that the adherence to and progression of the exercise routine of
participants walking at a reduced percentage of their body weight will increase relative to
those who must exercise at 100% of their body weight.
A secondary hypothesis is that participants who use the Alter-G with the anti-gravity
function will experience less pain and perceived exertion during exercise compared to those
who exercise at 100% of their body weight.
Finally, the investigators hypothesize that increased exercise adherence in those using the
anti-gravity function of the Alter-G will lead to increased fitness and improved muscle
function.
Status | Completed |
Enrollment | 26 |
Est. completion date | October 1, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 20-55 years - 30 and up BMI - Passing PAR-Q Exclusion Criteria: - diagnosed metabolic, cardiovascular, or renal disease, or symptoms of these diseases - participates in regular physical activity - experienced a large fluctuation in body weight - pregnant - blood pressure more than 140/90 - resting heart rate more than 100 per minute - hip size greater than 58" or less than 18.5" - weight more than 400 lb - height less than 4' 8" |
Country | Name | City | State |
---|---|---|---|
United States | Department of Kinesiology and Sport Managment | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University |
United States,
Bercier KL. Effect of Weight Loss Training Protocol Using Two Different Treadmills for Obese Individuals. Boise State University Theses and Dissertations: Boise State UniversityFollow; 2014.
Ekkekakis P, Lind E. Exercise does not feel the same when you are overweight: the impact of self-selected and imposed intensity on affect and exertion. Int J Obes (Lond). 2006 Apr;30(4):652-60. — View Citation
Hulens M, Vansant G, Claessens AL, Lysens R, Muls E. Predictors of 6-minute walk test results in lean, obese and morbidly obese women. Scand J Med Sci Sports. 2003 Apr;13(2):98-105. — View Citation
Williams DM. Exercise, affect, and adherence: an integrated model and a case for self-paced exercise. J Sport Exerc Psychol. 2008 Oct;30(5):471-96. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence differences between groups | compare adherence to exercise during a 12 week program between the participants in the control and experimental groups using percentage of visit attended and minutes completed each week. | 12 weeks | |
Secondary | difference in change in physical activity enjoyment between groups | difference in change for physical activity enjoyment is assessed using the physical activity enjoyment scale which is administered the first and last visits of the participants. The scale consist of 18 questions and the total will be obtained from the pre and post visits. The results from the post visit will have the first visit subtracted and the change will be the outcome. | From the first pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in quality of life between groups | Quality of life is recorded using the WHOQOL-BREF questionnaire. The questionnaire consist of a total and four domains which include physical health, psychological, social relationships, and environmental. The questionnaire is administered pre and post and the change is post subtracted by pre. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in self-efficacy between groups | Self-efficacy is recorded using the self-efficacy questionnaire. The questionnaire consist of five questions and is administered pre and post with the change deriving from post minus pre. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in rate of perceived excursion between groups | Rate of perceived excursion (RPE) is collected during each exercise session. RPE will be averaged for each exercise session for each participant, then averaged over the 12 weeks and compared between groups. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in pain between groups | Pain is assessed using the Short Form McGill pain questionnaire. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in subjective pain between groups | Subjective pain is collected during each exercise session. Subjective pain will be averaged for each exercise session for each participant, then averaged over the 12 weeks and compared between groups. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in 6-minute walk test between groups | The 6-minute walk test is administered pre and post and change is done by subtracting the pre from the post. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in timed up and go test between groups | The timed up and go test is administered pre and post and change is done by subtracting the pre from the post. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in heart rate during the 6-minute walk test between groups | During the 6-minute walk test heart rate is measured at 2,4,and 6 minutes. Each individuals heart rates during the pre test will be averaged then those totals will be averaged for each group, same for the post test. The change will be post minus pre groups averages. | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in blood pressure during the 6-minute walk test between groups | Blood pressure is administered right after completing the 6-minute walk test. The average blood pressure for each group for pre and post will be used to find change (post minus pre). | From pre to post visits, assessed for 12 weeks | |
Secondary | difference in change in rate of perceived excursion during the 6-minute walk test between groups | Rate of perceived excursion (RPE) is administered right after completing the 6-minute walk test. The average RPE is collected for each group for pre and post measurements, then post minus pre will get change in RPE. | From pre to post visits, assessed for 12 weeks |
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