Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Resistance Exercise Training
Inspiratory Muscle Training
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring bariatric surgery, inspiratory muscle strength, respiratory muscle endurance, functional capacity, peripheral muscle strength, quality of life, resistance exercise training, 6 - Minute Walk Test
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
Sites / Locations
- Bezmialem Vakıf Üniversitesi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Resistance Exercise Training Group
Inspiratory Muscle Training Group
Control Group
Arm Description
Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given
Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given
150 min per week walking suggestions were given.
Outcomes
Primary Outcome Measures
Forced Vital Capacity (FVC)
Respiratory Function Test
Forced Expiratory Volume in 1 second (FEV1)
Respiratory Function Test
FEV1/FVC
Respiratory Function Test
Peak Expiratory Flow (PEF)
Respiratory Function Test
Forced expiratory flow over the middle one half of the FVC (FEF25-75%)
Respiratory Function Test
maximum inspiratory pressure (MIP)
Respiratory Muscle Strength Test
Maximal Voluntary Ventilation
Respiratory Muscle Endurance Test
Hand-held Dynamometer
Dynamic Muscle Strength Test
5 times sit to stand test
Mobility Test
6 minutes walking test
functional capacity test
Quality of Life Scale Specific for Obese Persons
Quality of Life
maximum expiratory pressure (MEP)
Respiratory Muscle Strength Test
Hand grip dynamometer
Static Peripheral Muscle Strength Test
Secondary Outcome Measures
Full Information
NCT ID
NCT04375488
First Posted
April 17, 2020
Last Updated
June 19, 2020
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04375488
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance Exercise Training Group
Arm Type
Experimental
Arm Description
Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given
Arm Title
Inspiratory Muscle Training Group
Arm Type
Experimental
Arm Description
Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
150 min per week walking suggestions were given.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Respiratory Function Test
Time Frame
3 months
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Respiratory Function Test
Time Frame
3 months
Title
FEV1/FVC
Description
Respiratory Function Test
Time Frame
3 months
Title
Peak Expiratory Flow (PEF)
Description
Respiratory Function Test
Time Frame
3 months
Title
Forced expiratory flow over the middle one half of the FVC (FEF25-75%)
Description
Respiratory Function Test
Time Frame
3 months
Title
maximum inspiratory pressure (MIP)
Description
Respiratory Muscle Strength Test
Time Frame
3 months
Title
Maximal Voluntary Ventilation
Description
Respiratory Muscle Endurance Test
Time Frame
3 months
Title
Hand-held Dynamometer
Description
Dynamic Muscle Strength Test
Time Frame
3 months
Title
5 times sit to stand test
Description
Mobility Test
Time Frame
3 months
Title
6 minutes walking test
Description
functional capacity test
Time Frame
3 months
Title
Quality of Life Scale Specific for Obese Persons
Description
Quality of Life
Time Frame
3 months
Title
maximum expiratory pressure (MEP)
Description
Respiratory Muscle Strength Test
Time Frame
3 months
Title
Hand grip dynamometer
Description
Static Peripheral Muscle Strength Test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alis Kostanoğlu
Organizational Affiliation
Assistant professor
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakıf Üniversitesi
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients
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