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

Obesity, Morbid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375488
• Other study ID #: BVUtacar01
• Status: Completed
• Phase: N/A
• Start date: December 27, 2019
• Est. completion date: June 18, 2020

Study information

• Verified date: June 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 18, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Üniversitesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

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