Physical Activity Program After Bariatric Surgery

NCT ID: NCT03699683

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-01
• Study Completion Date: 2017-09-01

Brief Summary

Background: Bariatric surgery (BS) causes large weight reductions and improvements in cardiovascular risk (CVR), although, there are also decreases in fat-free mass (FFM). However, the effects of exercise after surgery on these variables remains to be determined.

Methods: 38 patients who underwent BS were divided into two groups: an experimental group (EG, n = 19) and a control group (CG, n = 19). Body composition, physical fitness, CVR and CVR factors were assessed in both groups one month after the surgery (T1), at 7 months (T2) and at 13 months (T3). Between T1 and T2, the EG performed a 6 month monitored aerobic and resistance combined training.

Detailed Description

Forty adults that underwent BS (sleeve gastrectomy and gastric bypass) were invited to participate in the study along two years (between 1-4 patients per month). After the initial interview, two patients refused to participate in the study. The participants provided written informed consent before starting the study. The study was approved by the Ethics Committee of the University in accordance with the Declaration of Helsinki. Participants were divided into two groups (experimental, EG; and control, CG) depending on when the BS was performed. The first 10 patients of each year were the EG (n=19) and the other mine patients were the CG (n=19). A 6-month supervised and individualized program that combined aerobic and resistance training (CART) was only conducted with the EG. Both groups followed a nutritional supervision and were evaluated in 3 different time periods: Test 1 (T1), before the intervention period (approximately 1 month after BS) with no differences in any variable measured; Test 2 (T2), after the intervention period (7 months after BS) and Test 3 (T3) to evaluate a retention period (13 months after BS). The tests included in the evaluation were: blood sample, body composition, blood pressure, physical fitness (cardiorespiratory fitness, isokinetic and isometric strength measures of the lower limbs) and CVR. The test protocols were divided into 3 days: 1) between 8:00 AM and 9:00 AM., a blood sample was collected. 2) 24 hours after, at the same hour, body composition and resting blood pressure were measured. In the afternoon (between 5:00 P.M. and 8:00 P.M.), muscle strength measures were obtained. 3) at least 72 hours after the second testing session day, a cardiorespiratory fitness test was performed. Body composition, blood pressure and strength and cardiovascular tests were conducted at the facilities of the Sports Research Centre (Elche, Spain), in a climatically controlled laboratory, with a temperature between 22-24º and relative air humidity between 45-60%. Before any testing, all participants attended two familiarization sessions to introduce testing procedures and minimize the learning effects over the measures

Conditions

Bariatric Surgery and Physical Activity

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Combined Activity Program

Before and after a 6-months supervised and individualized program that combined aerobic and resistance training were performed in post bariatric patients. Body composition, physical fitness and cardiovascular risk factors were measured before, after the physical activity program and 6 months later (13 months sinde the program started)

Group Type: EXPERIMENTAL

Combined aerobic and resistance training program

Intervention Type: OTHER

Interventions

Combined aerobic and resistance training program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Meet the age requirements

2. Be a patient of the reference hospital.

3. Follow the doctor's usual health prescriptions

Exclusion Criteria

1. Cardiovascular diseases

2. Chronic respiratory deseases

3. Cancer in the 5 years prior to surgery

4. Severe functional limitations

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 57 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

Manuel Moya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2015.60.E.OEP

Identifier Type: -

Identifier Source: org_study_id