Adherence to Walking on an Alter G Anti-Gravity Treadmill

NCT03690752 | Completed FDA Device

• 1 other identifier: IRB2017-275
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Obesity

Keywords

Obesity; Alter-G Anti-Gravity Treadmill; 6-minute walk test; timed up and go test; physical activity enjoyment; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• difference in change in physical activity enjoyment between groups

  From the first pre to post visits, assessed for 12 weeks

• difference in change in quality of life between groups

  From pre to post visits, assessed for 12 weeks

• difference in change in self-efficacy between groups

  From pre to post visits, assessed for 12 weeks

• difference in change in rate of perceived excursion between groups

  From pre to post visits, assessed for 12 weeks

• difference in change in pain between groups

  From pre to post visits, assessed for 12 weeks

Study Arms (2)

weighted

SHAM COMPARATOR

The weighted group uses the same Alter-G Treadmill as the unweighted group but were not allowed to use the unweighting function of the treadmill. Intervention: unweighting using Alter-G Anti-Gravity Treadmill

Device: normal weight using Alter-G Anti-Gravity Treadmill

unweighted

EXPERIMENTAL

The unweighted group uses the same Alter-G Anti-Gravity Treadmill as the weight group but is allowed to adjust their weight using the weight control feature. Intervention: normal weight using Alter-G Anti-Gravity Treadmill

Device: unweighting using Alter-G Anti-Gravity Treadmill

Interventions

unweighting using Alter-G Anti-Gravity Treadmill DEVICE

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.

Also known as: Lower body positive pressure

unweighted

normal weight using Alter-G Anti-Gravity Treadmill DEVICE

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.

Also known as: lower body positive pressure

weighted

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• and up BMI
• Passing PAR-Q

You may not qualify if:

• 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"

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Department of Kinesiology and Sport Managment

Lubbock, Texas, 79409, United States

Location

Related Publications (4)

• 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. doi: 10.1034/j.1600-0838.2003.10273.x.

  PMID: 12641641 BACKGROUND

• 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. doi: 10.1038/sj.ijo.0803052.

  PMID: 16130028 BACKGROUND

• 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. doi: 10.1123/jsep.30.5.471.

  PMID: 18971508 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Pain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Emily Dhurandhar, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 1, 2018
• Study Start: September 9, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After manuscript describing the study is released then the study protocol and analytic code will be shared.
• Access Criteria: Uploaded to Inter-university Consortium for Political and Social Research (ICPSR)

Locations

US (1)