Post-bariatric SurgeryNCT00793832
The Effect of Supervised Exercise on Physical Fitness and Energy Expenditure in Post Bariatric Surgery Patients
A study testing supervised exercise and Diet advice in people with Post-bariatric Surgery, run by University of Texas Southwestern Medical Center.
Trial summary
It is hypothesized that the patients in the EXDA group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-bariatric Surgery
- What is being tested?
- supervised exercise and Diet advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RYGB or GB surgery patients who are at least 12 weeks post surgery
- BMI of 40 or more
- age 18-70years
- sedentary lifestyle (energy expenditure of <35 kcal/kg/day measured by 7-day physical activity recall and no regular moderate physical activity exceeding 20 min/day within the previous 3 months)
- willingness to alter physical activity in accordance with the intervention programs
- English or Spanish speaking.
Who cannot join
- body weight > 180 kg
- cardiovascular disease
- pulmonary disease
- uncontrolled hypertension (resting DBP >100 or SBP >180 mm of Hg)
- visual or hearing impairment
- functional limitations (difficulty walking one-quarter mile or climbing 10 stairs)
Show all 16Show fewer
- abnormal ECG on VO2max test ( >1 mm ST segment depression at < 5 METS or with symptoms such as atrial fibrillation, complex ventricular arrhythmias and 3rd degree atrioventricular block)
- known liver disease due to causes other than nonalcoholic steatohepatitis (liver transaminases > 2.5 times the upper limits of normal [SGPT>105 U/L, SGPT>120 U/L] or total bilirubin >1.5 mg/dL)
- hematocrit of less than 30%
- current alcohol abuse (>7 drinks or 210 g/wk for women and >14 drinks or 420 g/wk for men)
- recreational drug abuse
- current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.)
- major neuro-psychiatric illnesses impeding competence or compliance
- pregnancy and lactation
- chronic renal insufficiency (serum creatinine > 2 mg/dL)
- untreated thyroid disorders such as hypothyroidism and hyperthyroidism; and 17) bariatric surgical complications including anastomotic leak, wound complications, thrombotic disorders, intestinal obstruction, stomal complications, GI bleeding, recurrent severe abdominal pain, bilious vomiting.
About this study
Official title: The Effect of Supervised Cardiorespiratory Endurance Exercise Training on Physical Fitness and Energy Expenditure in Roun-en-Y Gastric Bypass and Gastric Banding Surgery Patients.
It is hypothesized that the patients in the EXDA group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group.
- Conditions
- Post-bariatric Surgery
- Being tested
- supervised exercise, Diet advice
- Keywords
- weight loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised exerciseBehavioural
supervised exercise
Diet adviceBehavioural
Diet Advice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Supervised exercise. Receives: Behavioral: supervised exercise |
| 2 | Active comparator | Diet Advice Receives: Behavioral: Diet advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise at a level sufficient to accumulate at least 2000kcal per week
Measured: 12 weeks
Secondary outcomes (1)
To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhimanyu Garg, University of Texas Southwestern Medical Center
- Investigators
- Meena Shah, Ph.D, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793832
- Sponsor's protocol ID
- GCRC 837
- Status last verified
- Jan 2010
- First submitted
- 17 Nov 2008
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supervised Cardiorespiratory Endurance Exercise Training on Physical Fitness and Energy Expenditure in Roun-en-Y Gastric Bypass and Gastric Banding Surgery Patients.
- ClinicalTrials.gov ID
- NCT00793832
- Acronym / sponsor ID
- GCRC 837
- Conditions
- Post-bariatric Surgery
- Keywords
- weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hypothesized that the patients in the EXDA group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: supervised exerciseSupervised exercise. |
| 2 | Active comparator | Behavioral: Diet adviceDiet Advice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- RYGB or GB surgery patients who are at least 12 weeks post surgery
- BMI of 40 or more
- age 18-70years
- sedentary lifestyle (energy expenditure of <35 kcal/kg/day measured by 7-day physical activity recall and no regular moderate physical activity exceeding 20 min/day within the previous 3 months)
- willingness to alter physical activity in accordance with the intervention programs
Key exclusion criteria (16 listed)
- body weight > 180 kg
- cardiovascular disease
- pulmonary disease
- uncontrolled hypertension (resting DBP >100 or SBP >180 mm of Hg)
- visual or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised exercisesupervised exercise | Behavioural | 1 |
| Diet adviceDiet Advice | Behavioural | 2 |
Primary outcome
Exercise at a level sufficient to accumulate at least 2000kcal per week
Time frame: 12 weeks
1 secondary outcome
To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meena Shah, Ph.D principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing supervised exercise and Diet advice in people with Post-bariatric Surgery, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise at a level sufficient to accumulate at least 2000kcal per week (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.