Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass

NCT01690728 | Completed DMC

• 1 other identifier: CBR-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Inactivity

Keywords

Obesity; Gastric bypass

Outcome Measures

Primary Outcomes (1)

• Weight loss

  The participants pre-operative weight are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Weight change from baseline will be measured 6, 12 and 24 months post-surgery.

  Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery

Secondary Outcomes (1)

• Blood tests

  Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery

Study Arms (2)

Physical Activity

ACTIVE COMPARATOR

40 min exercise supervised by physiotherapists two times weekly in six month.

Behavioral: Physical Activity

Control Group

NO INTERVENTION

These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Interventions

Physical Activity BEHAVIORAL

The intervention program will continue for six month consisting of two weekly sessions of 40 min exercise supervised by physiotherapists. The supervised exercise program will take place at the training center Fitness.dk in Esbjerg and Kolding. It will be in cooperation with physiotherapists at the Therapy Department of Sydvestjysk Sygehus Esbjerg and the Therapy Department of Fredericia and Kolding Sygehus, Sygehus Lillebælt. The exercise program at the two centers will be equal. In addition the patients will be provided with free access to a fitness center. The patient will be encouraged to do at least 3.5 hours of moderate to vigorous physical activity per week.

Physical Activity

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark

Esbjerg, 6700, Denmark

Location

Related Publications (3)

• 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.

  PMID: 30046976 DERIVED

• 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.

  PMID: 29677629 DERIVED

• 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.

  PMID: 29566463 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Sedentary Behavior; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claus B Juhl, MD, ph.d.

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD-student

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 24, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2016
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)