Department of Kinesiology and Sport Managment
Lubbock, Texas, 79409, United States
NCT Number: NCT03690752
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.
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Notify Me20 year–55 year
All sexes
Interventional
Not applicable
Lubbock, Texas, 79409, United States
Screening
III.) Exercise Protocol:
Scheduling:
Before beginning phases of the program, participants will be shown a physical calendar that will be located in the same room as the treadmill. They will be able to come in and select time slots in which they are available. Once a time slot has been filled it may not be reserved by another participant. If a schedule change is needed the participants will be allowed to come in and change it on the calendar and reserve an open time slot, while removing their name from the one they will be missing, or email the study coordinator and have a student or faculty member on the project change it for them.
Participants will take part in information and orientation session before scheduling begins. Informed consent will be obtained during this time, and this information session will serve as an overview of the program, and will introduce them to the Alter-G antigravity treadmill. They will be informed on how this exercise program will proceed, and will be told what to expect. Orientation Session During the orientation session, first measure blood pressure and resting heart rate as a final screening measure, and make sure it is not above 140/90 or heart rate (HR) of 90. The investigator will then review the study brochure with participants and complete informed consent. Once informed consent is obtained, participants will randomize them perform the sit-to-stand assessment followed by the 6 minute walk assessment then introduce them to the treadmill according to the following protocols:
Unweighting group:
Control Group:
Goals:
o During the first session, as participants are walking on treadmill, the investigator will be recording these measurements.
Treatment:
Goals:
o Encourage participants to increase workload intensity and aim for longer and more frequent sessions on the treadmill.
o Answer any questions the participants may have.
Final Session:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The unweighted group (experimental) is allowed to self-select a comfortable unweighting using the weight control feature on the Alter-G Anti-Gravity Treadmill. Both groups use the same Alter-G Anti-Gravity Treadmill and both groups are about to self-select speed, incline, and duration.
Other names: Lower body positive pressure
The weighted (control) group will walk at 100% their body weight using the Alter-G Anti-Gravity Treadmill. Both groups use the same Alter-G Anti-Gravity Treadmill and both groups are about to self-select speed, incline, and duration.
Other names: lower body positive pressure
Time frame: 12 weeks
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.
Time frame: From the first pre to post visits, assessed for 12 weeks
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.
Time frame: From pre to post visits, assessed for 12 weeks
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.
Time frame: From pre to post visits, assessed for 12 weeks
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.
Time frame: From pre to post visits, assessed for 12 weeks
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.
Time frame: From pre to post visits, assessed for 12 weeks
Pain is assessed using the Short Form McGill pain questionnaire.
Time frame: From pre to post visits, assessed for 12 weeks
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.
Time frame: From pre to post visits, assessed for 12 weeks
The 6-minute walk test is administered pre and post and change is done by subtracting the pre from the post.
Time frame: From pre to post visits, assessed for 12 weeks
The timed up and go test is administered pre and post and change is done by subtracting the pre from the post.
Time frame: From pre to post visits, assessed for 12 weeks
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.
Time frame: From pre to post visits, assessed for 12 weeks
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).
Time frame: From pre to post visits, assessed for 12 weeks
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.
Texas Tech University
Other
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