Skip to main content
OpenTrials
Completed

NCT Number: NCT04375488

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf Üniversitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Exercise Training

Other

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

Other

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

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 3 months

    Respiratory Function Test

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 3 months

    Respiratory Function Test

  3. FEV1/FVC

    Time frame: 3 months

    Respiratory Function Test

  4. Peak Expiratory Flow (PEF)

    Time frame: 3 months

    Respiratory Function Test

  5. Forced expiratory flow over the middle one half of the FVC (FEF25-75%)

    Time frame: 3 months

    Respiratory Function Test

  6. maximum inspiratory pressure (MIP)

    Time frame: 3 months

    Respiratory Muscle Strength Test

  7. Maximal Voluntary Ventilation

    Time frame: 3 months

    Respiratory Muscle Endurance Test

  8. Hand-held Dynamometer

    Time frame: 3 months

    Dynamic Muscle Strength Test

  9. 5 times sit to stand test

    Time frame: 3 months

    Mobility Test

  10. 6 minutes walking test

    Time frame: 3 months

    functional capacity test

  11. Quality of Life Scale Specific for Obese Persons

    Time frame: 3 months

    Quality of Life

  12. maximum expiratory pressure (MEP)

    Time frame: 3 months

    Respiratory Muscle Strength Test

  13. Hand grip dynamometer

    Time frame: 3 months

    Static Peripheral Muscle Strength Test

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.