Effects of Exercise Training in Individuals Undergoing Bariatric Surgery

NCT05085015 | Completed

• 1 other identifier: Unique Protocol ID: 2021-0071
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The subject of the research; Effects of exercise training on cardiometabolic risk factors and functional capacity in individuals undergoing bariatric surgery. Purpose of the research; Cardiometabolic risk factors, body composition, muscle strength and endurance, posture, foot sense, physical exercise capacity, balance, pain, exercise benefits - barriers, exercise self-efficacy, exercise beliefs, to evaluate the effects on body esteem, body image and quality of life. Method of Research: Post-surgical interventions are important in individuals who have undergone bariatric surgery. Intervention programs that include exercise, encourage the change in the lifestyle of individuals, effectively and accurately reduce post-surgical obesity. Functional Exercise Training, which can also be used for obesity treatment, consists of stretching, aerobics, strengthening and balance training. Therefore, it has a positive effect on body systems. In addition, Home Exercise Training can be used within the scope of obesity treatment. Exercise is one of the alternative methods by providing the adaptation of the individual to the exercise. Socio-demographic and physical characteristics of individuals will be recorded. Laboratory tests will be ordered for cardiometabolic risk factors. Body composition will be determined by Tanita brand body analysis monitor (MC-780MA). Posture will be evaluated by photogrammetry technique. Muscle strength assessment will be evaluated by leg, back and hand dynamometer instrument, muscle endurance tests, sensory assessment by foot sense assessment, physical capacity with physical exercise capacity tests, balance static and dynamic balance tests and pain questionnaire. Exercise benefits-barriers will be assessed by Exercise Benefits Barriers Scale, exercise self-efficacy by Exercise Self-Efficacy Scale. Exercise beliefs will also be questioned with a questionnaire. Self-esteem will be evaluated for all groups before and after treatment. The self respect will be evaluated by using the Rosenberg Self-Esteem Scale, body image with the Body Image Scale, with the quality of life using the Obesity-Specific Quality of Life Scale.The training will be carried out 3 days a week for 8 weeks, approximately 1 hour. Sufficient number of assessments and exercises will be used for individuals to become familiar with the equipment and training protocol.

Conditions

Obesity

Keywords

Bariatrics; Obesity; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance

  Laboratory tests for the insulin resistance of the individuals will be obtained from the findings that are routinely requested and made by the doctor. For Insulin Resistance; Insulin resistance (HOMA-IR) test will be done by taking a blood test in the laboratory (Blood glucose taken after 8-10 hours of fasting and fasting insulin level will be multiplied by each other and divided by 405 and the insulin resistance level called HOMA-IR will be revealed.)

  change from baseline at 8 weeks after the intervention

Secondary Outcomes (30)

• Body Analysis Monitor

  change from baseline at 8 weeks after the intervention

• Waist and hip circumference

  change from baseline at 8 weeks after the intervention

• Muscle Strength

  change from baseline at 8 weeks after the intervention

• Sorensen Test

  change from baseline at 8 weeks after the intervention

• Trunk Flexor Muscle Endurance Test

  change from baseline at 8 weeks after the intervention

Study Arms (2)

Functional Exercise Training Group

EXPERIMENTAL

A program including stretching, aerobics, strengthening and balance training will be implemented under the supervision of a physiotherapist with the instructions of the physiotherapist.They will apply a total of 24 sessions of exercise program for 60-80 minutes, 3 days a week, 8 weeks.

Other: Functional Exercise Training Group

Home Exercise Training Group

EXPERIMENTAL

Individuals in the home exercise training program will be asked to follow the program in accordance with the home exercise brochure given for 8 weeks, 3 days a week. The program will include stretching, aerobics, strengthening and balance training. The home exercise program will consist of a brochure prepared from a program similar to a functional exercise program.

Other: Home Exercise Training Group

Interventions

Functional Exercise Training Group OTHER

Training will start with Stretching Training and end with stretching training. Stretching exercises targeting actively applied shoulder girdle, chest, neck, trunk, hip, front and back leg and ankle muscle groups will be given. Afterwards, it will be continued with Aerobic Exercise Training. The training will be given on the treadmill "Treadmill Technogym". Afterwards, it will be continued with Strengthening Training. Strength training will consist of a strengthening program that includes the lower extremity, upper extremity, trunk and core region. Elastic bands will be used in the training. Then, balance training will be given at the end.

Functional Exercise Training Group

Home Exercise Training Group OTHER

Training will start with Stretching Training and end with stretching training. Stretching exercises targeting actively applied shoulder girdle, chest, neck, trunk, hip, front and back leg and ankle muscle groups will be given. Afterwards, it will be continued with Aerobic Exercise Training. They will walk at least 30 minutes, 3 days a week for 8 weeks at outdoor. Afterwards, it will be continued with Strengthening Training. Strength training will consist of a strengthening program that includes the lower extremity, upper extremity, trunk and core region. Elastic bands will be used in the training. Then, balance training will be given at the end.

Home Exercise Training Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 20-60 years,
• Those who have passed 1 month to 2 years after the operation,
• Lack of a regular exercise program for the last 6 months (3 and 20 minutes per week.

You may not qualify if:

• Uncontrollable Hypertension (systolic≥160, diastolic≤90 mmHg), Diabetes, Cancer and Cardiovascular Disease
• Those who have orthopedic, neurological or mental illnesses that prevent them from exercising
• Previous bariatric surgery
• Use of drugs that will affect body composition that will cause weight or energy expenditure
• Having vision, hearing and communication problems

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Hayriye Tomaç

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator specialist physiotherapist

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: October 20, 2021
• Study Start: December 10, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CY (1)