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

M

Modulex

Status

Completed

Conditions

Inactivity
Morbid Obesity

Treatments

Behavioral: Physical Activity

Study type

Interventional

Funder types

Other

Identifiers

NCT01690728
CBR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Physical Activity
Active Comparator group
Description:
40 min exercise supervised by physiotherapists two times weekly in six month.
Treatment:
Behavioral: Physical Activity
Control Group
No Intervention group
Description:
These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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