Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Completed

CT.gov ID

NCT04375488

Collaborator

(none)

Enrollment

Location

Arms

5.7

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the investigator's study is to investigate whether postoperative inspiratory muscle training and resistance exercise training has an effect on functional capacity, respiratory functions, respiratory muscle strength and endurance in patients undergoing bariatric surgery.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Other: Resistance Exercise Training Other: Inspiratory Muscle Training	N/A

Detailed Description

Obesity is an important health problem that can affect the entire organ and system of the body, leading to various disorders and even death. The fact that BMI is over 40 kg / m2 is defined as morbid obesity. The most effective treatment step in morbid obesity is bariatric surgery.

The impairment of inspiratory muscle function related to obesity is associated with increased lung elastic load, excessive lengthening in the abdominal muscles, and dissolution of the diaphragm, leading to inspiratory muscle weakness and insufficiency. The decrease in its endurance is explained by the decrease of glycogen synthase activity in skeletal muscles. It was found that there was less decrease in the inspiratory muscle training patients whose MIP values were measured before bariatric surgery compared to those who could not do MIP values after surgery.

Respiratory functions due to obesity are impaired due to restrictive mass increase in chest wall, tendency to breathe in low lung volumes and the effect of fat distribution on pleural pressure. Total lung volume, expiratory reserve volume (ERV), reserve volume (RV), vital capacity (VC), functional residual capacity (FRC), FVC, and FEV1 values are low.

After bariatric surgery, patients' muscle strength decreased. In particular, there was a decrease in muscle strength in quadriceps, hamstring, biceps, triceps. The decrease in muscle strength after surgery has been associated with a decrease in muscle mass. It was stated that patients who did not exercise after surgery lost 7.6 kg of muscle, which was 29.7% of the total lost body weight. Resistance exercises performed after bariatric surgery have a positive impact on patients' muscle strength and functional capacity.

Obesity causes a decrease in functional capacity. Increased step width, reduced walking speed and step length are shown for the main reasons. Decreased inspiratory muscle strength in patients undergoing surgery causes weakness in peripheral muscles. This weakness in peripheral muscles also reduces the functional capacity of patients. Inspiratory muscle training studies increase the functional capacity.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect Of Postoperative Inspiratory Muscle Training And Strength Exercise Training On Functional Capacity, Quality of Life, Respiratory Functions, Respiratory Muscle Strength And Endurance in Bariatric Surgery Patients

Actual Study Start Date :

Dec 27, 2019

Actual Primary Completion Date :

May 21, 2020

Actual Study Completion Date :

Jun 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resistance Exercise Training Group Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given	Other: Resistance Exercise Training 60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week
Experimental: Inspiratory Muscle Training Group Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given	Other: Resistance Exercise Training 60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week Other: Inspiratory Muscle Training with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week
No Intervention: Control Group 150 min per week walking suggestions were given.

Arm

Intervention/Treatment

Experimental: Resistance Exercise Training Group

Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given

Other: Resistance Exercise Training

60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week

Experimental: Inspiratory Muscle Training Group

Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given

Other: Resistance Exercise Training

Other: Inspiratory Muscle Training

with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week

No Intervention: Control Group

150 min per week walking suggestions were given.

Outcome Measures

Primary Outcome Measures

Forced Vital Capacity (FVC) [3 months]
Respiratory Function Test
Forced Expiratory Volume in 1 second (FEV1) [3 months]
Respiratory Function Test
FEV1/FVC [3 months]
Respiratory Function Test
Peak Expiratory Flow (PEF) [3 months]
Respiratory Function Test
Forced expiratory flow over the middle one half of the FVC (FEF25-75%) [3 months]
Respiratory Function Test
maximum inspiratory pressure (MIP) [3 months]
Respiratory Muscle Strength Test
Maximal Voluntary Ventilation [3 months]
Respiratory Muscle Endurance Test
Hand-held Dynamometer [3 months]
Dynamic Muscle Strength Test
5 times sit to stand test [3 months]
Mobility Test
6 minutes walking test [3 months]
functional capacity test
Quality of Life Scale Specific for Obese Persons [3 months]
Quality of Life
maximum expiratory pressure (MEP) [3 months]
Respiratory Muscle Strength Test
Hand grip dynamometer [3 months]
Static Peripheral Muscle Strength Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having a body mass index (BMI) ≥40kg / m2 or
(BMI) ≥35kg/m2 and at least one concomitant disease associated with obesity
To participate regularly in treatment

Exclusion Criteria:

Using assistive device while walking
Lung infection in the past 1 month
Chronic obstructive pulmonary disease (COPD)
Having an orthopedic, neurological disease that will prevent him/her from exercising
Uncontrollable hypertension
Pregnancy