Clinical trial NCT04375488: Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: bariatric surgery
inspiratory muscle strength
respiratory muscle endurance
functional capacity
peripheral muscle strength
quality of life
resistance exercise training
6 - Minute Walk Test
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 3 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 3 months
measure: FEV1/FVC
timeFrame: 3 months
measure: Peak Expiratory Flow (PEF)
timeFrame: 3 months
measure: Forced expiratory flow over the middle one half of the FVC (FEF25-75%)
timeFrame: 3 months
measure: maximum inspiratory pressure (MIP)
timeFrame: 3 months
measure: Maximal Voluntary Ventilation
timeFrame: 3 months
measure: Hand-held Dynamometer
timeFrame: 3 months
measure: 5 times sit to stand test
timeFrame: 3 months
measure: 6 minutes walking test
timeFrame: 3 months
measure: Quality of Life Scale Specific for Obese Persons
timeFrame: 3 months
measure: maximum expiratory pressure (MEP)
timeFrame: 3 months
measure: Hand grip dynamometer
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Üniversitesi
Study officials:
affiliation: Assistant professor
name: Alis Kostanoğlu
role: STUDY_CHAIR
References: