Obesity, MorbidNCT04375488
Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients
A study testing Resistance Exercise Training and Inspiratory Muscle Training in people with Obesity, Morbid, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Resistance Exercise Training and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2019to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- Resistance Exercise Training, Inspiratory Muscle Training
- Keywords
- bariatric surgery, inspiratory muscle strength, respiratory muscle endurance, functional capacity, peripheral muscle strength, quality of life, resistance exercise training, 6 - Minute Walk Test
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TrainingOther
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 TrainingOther
with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Training Group | Experimental | Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given Receives: Other: Resistance Exercise Training |
| Inspiratory Muscle Training Group | Experimental | Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given Receives: Other: Resistance Exercise Training; Other: Inspiratory Muscle Training |
| Control Group | No intervention | 150 min per week walking suggestions were given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Respiratory Function Test
Measured: 3 months
Forced Expiratory Volume in 1 second (FEV1)
Respiratory Function Test
Measured: 3 months
FEV1/FVC
Respiratory Function Test
Measured: 3 months
Peak Expiratory Flow (PEF)
Respiratory Function Test
Measured: 3 months
Forced expiratory flow over the middle one half of the FVC (FEF25-75%)
Respiratory Function Test
Measured: 3 months
maximum inspiratory pressure (MIP)
Respiratory Muscle Strength Test
Measured: 3 months
Maximal Voluntary Ventilation
Respiratory Muscle Endurance Test
Measured: 3 months
Hand-held Dynamometer
Dynamic Muscle Strength Test
Measured: 3 months
5 times sit to stand test
Mobility Test
Measured: 3 months
6 minutes walking test
functional capacity test
Measured: 3 months
Quality of Life Scale Specific for Obese Persons
Quality of Life
Measured: 3 months
maximum expiratory pressure (MEP)
Respiratory Muscle Strength Test
Measured: 3 months
Hand grip dynamometer
Static Peripheral Muscle Strength Test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start27 Dec 2019
- Primary completion21 May 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alis Kostanoğlu, Study chair, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375488
- Sponsor's protocol ID
- BVUtacar01
- Status last verified
- Jun 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04375488
- Acronym / sponsor ID
- BVUtacar01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Training Group | Experimental | Other: Resistance Exercise TrainingResistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given |
| Inspiratory Muscle Training Group | Experimental | Other: Resistance Exercise Training, Other: Inspiratory Muscle TrainingResistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given |
| Control Group | No intervention | –150 min per week walking suggestions were given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise Training60 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 Group, Resistance Exercise Training Group |
| Inspiratory Muscle Trainingwith % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week | Other | Inspiratory Muscle Training Group |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: 3 months
Respiratory Function Test
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 3 months
Respiratory Function Test
FEV1/FVC
Time frame: 3 months
Respiratory Function Test
Peak Expiratory Flow (PEF)
Time frame: 3 months
Respiratory Function Test
Forced expiratory flow over the middle one half of the FVC (FEF25-75%)
Time frame: 3 months
Respiratory Function Test
maximum inspiratory pressure (MIP)
Time frame: 3 months
Respiratory Muscle Strength Test
Maximal Voluntary Ventilation
Time frame: 3 months
Respiratory Muscle Endurance Test
Hand-held Dynamometer
Time frame: 3 months
Dynamic Muscle Strength Test
5 times sit to stand test
Time frame: 3 months
Mobility Test
6 minutes walking test
Time frame: 3 months
functional capacity test
Quality of Life Scale Specific for Obese Persons
Time frame: 3 months
Quality of Life
maximum expiratory pressure (MEP)
Time frame: 3 months
Respiratory Muscle Strength Test
Hand grip dynamometer
Time frame: 3 months
Static Peripheral Muscle Strength Test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alis Kostanoğlu study chair
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training and Inspiratory Muscle Training in people with Obesity, Morbid, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.