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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lene Hymøller Mundbjerg, Hospital of South West Denmark
ClinicalTrials.gov Identifier:
NCT01690728
First received: September 14, 2012
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Morbid Obesity Inactivity Behavioral: Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass

Resource links provided by NLM:


Further study details as provided by Lene Hymøller Mundbjerg, Hospital of South West Denmark:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery ]
    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.


Secondary Outcome Measures:
  • Blood tests [ Time Frame: Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery ]
    Exhaustive panel of blood tests related to cardiovascular risk. The participants are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Changes in blood analyses from baseline will be measured 6, 12 and 24 months post-surgery.


Enrollment: 60
Actual Study Start Date: October 2012
Study Completion Date: November 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physical Activity
40 min exercise supervised by physiotherapists two times weekly in six month.
Behavioral: Physical Activity
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.
No Intervention: Control Group
These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.

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

Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690728

Locations
Denmark
Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Denmark
Investigators
Principal Investigator: Claus B Juhl, MD, ph.d. Hospital of South West Denmark
  More Information

Responsible Party: Lene Hymøller Mundbjerg, M.D. PhD-student, Hospital of South West Denmark
ClinicalTrials.gov Identifier: NCT01690728     History of Changes
Other Study ID Numbers: CBR-001
Study First Received: September 14, 2012
Last Updated: March 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lene Hymøller Mundbjerg, Hospital of South West Denmark:
Obesity
Gastric bypass

Additional relevant MeSH terms:
Weight Loss
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on July 21, 2017