Clinical trial NCT01690728: Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass
Official title: Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Inactivity
Keywords: Obesity
Gastric bypass
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to increase our knowledge about the effect of physical activity in patients who have undergone gastric bypass surgery. The study will provide novel information in two areas. The main objective is to study the effect of physical activity on the weight loss and cardiovascular risk factors. This will be accomplished in a randomized clinical trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to six month of structured physical activity or standard postoperative counseling. The study will include an exhaustive panel of blood tests related to cardiovascular risk and the most extensive evaluation of structural and functional vascular test done in this patient group so far. In addition the study will provide information of the effect of bariatric surgery per se since both pre- and postoperative investigations are conducted. The study will learn us to what degree it is possible to motivate this group of patients to increased physical activity. All together this will enable us to improve the counseling of the patients undergoing GB.

Detailed description: The study will be conducted as a prospective, randomized, controlled, two-group, intervention study. Patients will be recruited among individuals referred to the tertiary center for bariatric surgery. The patients will be asked to participate in the study when they attend the preoperative education for bariatric surgery. Randomization will be performed in blocks ensuring an equal distribution of type 2 diabetes patients in the two study groups.

Participants will be investigated before gastric bypass surgery, six, 12 and 24 month post-operative. Intervention, consisting of structured physical activity will take place from six to 12 month after operation.

The intervention program will continue for six month. The supervised exercise program will take place at the training center consisting of 40 min. sessions two times pr. week for 26 consecutive weeks.

Eligibility criteria: Inclusion Criteria:

* Age 25 - 60 years
* Able to understand and cooperate with the interventions in the study
* Eligible for gastric bypass surgery

Exclusion Criteria:

* Inability to perform physical activity at the intensity and quantity required in the study, such as physical disabled patients including severe osteoarthritis
* Use of vitamin K antagonists, oral contraceptives, or hormone replacement therapy

Primary outcomes:
measure: Weight loss
timeFrame: Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery
Secondary outcomes:
measure: Blood tests
timeFrame: Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Claus B Juhl, MD, ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stolberg CR, Mundbjerg LH, Bladbjerg EM, Funch-Jensen P, Gram B, Juhl CB. Physical training following gastric bypass: effects on physical activity and quality of life-a randomized controlled trial. Qual Life Res. 2018 Dec;27(12):3113-3122. doi: 10.1007/s11136-018-1938-9. Epub 2018 Jul 25.
citation: Stolberg CR, Mundbjerg LH, Funch-Jensen P, Gram B, Bladbjerg EM, Juhl CB. Effects of gastric bypass surgery followed by supervised physical training on inflammation and endothelial function: A randomized controlled trial. Atherosclerosis. 2018 Jun;273:37-44. doi: 10.1016/j.atherosclerosis.2018.04.002. Epub 2018 Apr 6.
citation: Mundbjerg LH, Stolberg CR, Cecere S, Bladbjerg EM, Funch-Jensen P, Gram B, Juhl CB. Supervised Physical Training Improves Weight Loss After Roux-en-Y Gastric Bypass Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 May;26(5):828-837. doi: 10.1002/oby.22143. Epub 2018 Mar 22.