Exercise Training Study Before Bariatric Surgery
Key facts
- Who runs it
- University of Virginia
- Where
- Charlottesville, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 1 Jul 2024
- Ended
- 15 Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Exercise Group
- Record updated
- 14 June 2024
- Why it stopped
- Project during development was discontinued before the enrollment of participants
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- BMI: 35 - 45 kg/m2. For adults of Asian race or descent, the BMI cutoff is between 25-27.5 kg/m2 to be considered for surgery and thus will be considered for inclusion in this study
- Considered sedentary based on self-reported inactivity of < 2-3 x/week of MVPA within previous 3 months before enrollment
- Able to walk without use of assistive device, such as cane or walker for ≥ 10 minutes
- Surgery approved within 6-9 months of initial visit
- Signed approval from study physician (Dr. Catherine W. Varney; Medical PI of study) that participant is capable to participate
- Willingness to accept group randomization assignment
Who cannot take part
- Currently taking medications that lead to significant weight loss (e.g., semaglutide; tirzepatide, etc)
- Previous weight-loss surgeries or revisions
- Any serious medical conditions, such as cancer; history cardiovascular disease of stroke, heart attack, or heart failure; type 1 diabetes mellitus; severe psychiatric illness (such as severe depression); kidney disease
- Autoimmune diseases such as lupus, multiple sclerosis, Graves' disease, or rheumatoid arthritis
- HIV or tuberculosis
- Any medical or health condition (e.g., musculoskeletal, orthopedic, or neurological conditions) that is contraindicated for safe exercise testing and training
- Resting SBP > 150 mmHg, DBP > 100 mmHg
- Current pregnancy or plans to become pregnant during intervention
- Plans to be away from the Charlottesville, VA area for > 1 week during intervention or plans of relocating during the intervention
Where in United States
- University of VirginiaCharlottesville, United States
About the trial
What the trial wants to find out
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).
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Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.
Researchers will compare the effects of walking before bariatric surgery on:
* Insulin sensitivity (diabetes risk factor) * Health of blood vessels * Rate of complications after surgery * Weight * Body Fat * Fitness level
The 2 groups in the trial
- Exercise Group (EX-group)Treatment being tested
The EX-group will complete 8 weeks of supervised aerobic exercise training. The EX-group will also continue normal care with bariatric doctors and nurses along with the exercise intervention.
Treatment: Exercise Group
- Standard Care Only Group (SC-group)No study treatment, for comparison
The SC-group will only complete the orientation visit and testing visits. The participants that are randomized to this group will continue normal care with bariatric doctors and nurses. They will participate in study assessment visits only.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 June 2024