Metabolic SyndromeNCT03523026
The Effects of Muscle Training in Coronary Artery Patients With Metabolic Syndrome
A study testing Neuromuscular Electrical Stimulation, Inspirator Muscle Training and Peripheral Muscle Training in people with Metabolic Syndrome and Coronary Artery Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in coronary artery patients with metabolic syndrome. Prospectively, randomly, double-blind, and controlled study. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Metabolic Syndrome, Coronary Artery Disease
- What is being tested?
- Neuromuscular Electrical Stimulation, Inspirator Muscle Training and Peripheral Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 30 Dec 2018
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable coronary artery disease with metabolic syndrome diagnosis
- The ejection fraction(EF) = % 40 and EF >% 40,
- Participation to the study will be in a voluntary basis
Who cannot join
- Over 80 years,
- EF <40% or New York Heart Association (NYHA) class III-IV
- Chronic obstructive pulmonary disease (COPD) and respiratory tract infection,
- Documented diagnosis of pulmonary, neurological,orthopedic, renal, hepatic, gastrointestinal, endocrine, oncologic
- New or suspected thromboembolic events
- Severe refractory hypertension
Show all 9Show fewer
- Acute myocardial infarction and pulmonary edema in the last 6 months,
- Coronary artery revascularization attempts (percutaneous transluminal coronary angioplasty and coronary artery bypass surgery) and previous valve surgery in the last 6 months,
- Cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kıymet Muammer
Istanbul, Fatih/Istanbul, 34096
About this study
Official title: The Effects of Peripheral and Respiratory Muscle Training in Coronary Artery Patients With Metabolic Syndrome: A Randomized, Prospective, Double-Blind and Controlled Trial
The aim of this study is to investigate the effects of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in coronary artery patients with metabolic syndrome. Prospectively, randomly, double-blind, and controlled study. Stable coronary artery patients with metabolic syndrome will be included to the study from the Istanbul University Cardiology Institute clinic. Patients will be randomized into 3 groups; Neuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training Group (n: 20): 3 days per week for 6 weeks duration. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.Inspirator Muscle Training (IMT) and peripheral muscle training Group (n: 20): IMT will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator. Training intensity will set at 30% of the maximum inspiratory pressure.Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks. Peripheral Muscle Training Group (n: 20): Exercise will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.Parameters will be recorded before and after training. Evaluation parameters:Demographic and anthropometric measurements, respiratory function test,respiratory muscle strength,dyspnea, peripheral muscle strength, 6 minutes walking test, physical activity, quality of life, depression, sleep quality and laboratory evaluation.
Read the detailed description
Metabolic syndrome (MS) is a fatal endocrinopathy that appears with insulin resistance and is associated with systemic disorders such as abdominal obesity, glucose intolerance or diabetes mellitus, dyslipidemia, hypertension and coronary artery disease (CAD). The metabolic syndrome, which is regarded as an important public health problem in the world, shows a global increase.
Studies have showed that increased risk for cardiopulmonary disease is associated with people with metabolic syndrome. In the treatment of cardiopulmonary risk factors, therapeutic lifestyle changes and exercise are recommended in primary care strategy. Exercise training programs have been found to have positive effects on cardiopulmonary and metabolic parameters.It has been shown that respiratory functions are also adversely affected in these patients. In patients with metabolic syndrome, FEV1 and FVC were found to be influenced by decreased respiratory function and restrictive ventilation impairment.
Decreased respiratory functions and physical activity in patients with Metabolic Syndrome accompanied by multifactorial risks and complications will adversely affect quality of life. There are no studies in the literature that investigate the effects of peripheral and respiratory muscle training in patients with Metabolic Syndrome. Therefore, we aimed to investigate the effect of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in patients with Metabolic Syndrome. This study also aimed to contribute to the international literature by applying respiratory muscle training in patients with coronary artery disease with metabolic syndrome. In addition, in clinically structured rehabilitation programs, in coronary artery disease patients with metabolic syndrome will be provided with a questioning of the importance of respiratory muscle training.
The study will be planned as prospective, randomized, double blind and controlled. Access to the patients will be provided through an archive of patient records and a screening through the online system of the outpatient clinic. Before and after the training patients' effort tests and biochemical tests will be requested. Evaluations before and after the training will be done by another physiotherapist. The study will be conducted prospectively, randomly, double-blind, and controlled. Patients will be randomized into 3 groups.
NMES and Peripheral Muscle Training Group (n: 20).
IMT and Peripheral Muscle Training Group (n: 20),
Peripheral Muscle Training Group (n = 20).
NMES and Peripheral Muscle Training Group: NMES to rectus abdominis will be applied using 4 carbon silicon electrode. In the first sessions, patients ECG will be checked. Patients will be in semi-fowler position (30º),with their lower limbs to be in extension and upper limbs at their sides. The NMES frequency will be at 30 Hertz and the application time will be 30 minutes. Treatment will be programmed for 3 days per week. The patients will coordinate their breath (inspiration) with the contraction which will be generated by the electrical current. Peripheral muscle training will also be given. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.
IMT and Peripheral Muscle Training Group: IMT will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator. Training intensity will set at 30% of the maximum inspiratory pressure. Peripheral muscle training will also be given. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.
Peripheral Muscle Training Group: Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.
The rehabilitation program duration will be 6 weeks in all groups. Changes in parameters will be analyzed before and after treatment.
- Conditions
- Metabolic Syndrome, Coronary Artery Disease
- Being tested
- Neuromuscular Electrical Stimulation, Inspirator Muscle Training, Peripheral Muscle Training
- Keywords
- Metabolic Syndrome, Coronary Artery Patients, Neuromuscular Electrical Stimulation, Respiratory Muscle Training, Peripheral Muscle Training
- Medical subject headings
- Metabolic Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationDevice
Neuromuscular Electrical Stimulation(NMES) to rectus abdominis will be applied using 4 carbon silicon electrode. In the first sessions, patients ECG will be checked. Patients will be in semi-fowler position (30º),with their lower limbs to be in extension and upper limbs at their sides. The NMES frequency will be at 30 Hertz and the application time will be 30 minutes. Treatment will be programmed for 3 days per week. The patients will coordinate their breath (inspiration) with the contraction which will be generated by the electrical current. The program will continue for 6 weeks.
Inspirator Muscle TrainingOther
Inspirator Muscle Training(IMT) will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator.Training intensity will set at 30% of the maximum inspiratory pressure.
Peripheral Muscle TrainingOther
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NMES and Peripheral Muscle Training | Experimental | Neuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training
NMES frequency will be 30 Hertz and the application time will be 30 minutes.Treatment will be programmed for 3 days per week.
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks. Receives: Device: Neuromuscular Electrical Stimulation; Other: Peripheral Muscle Training |
| IMT and Peripheral Muscle Training | Experimental | Inspirator Muscle Training (IMT) and Peripheral Muscle Training
IMT will be applied 7 days per week, twice a day for 15 minutes.
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week. The program will continue for 6 weeks. Receives: Other: Inspirator Muscle Training; Other: Peripheral Muscle Training |
| Peripheral Muscle Training | Experimental | Peripheral Muscle Training
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks. Receives: Other: Peripheral Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure (MIP)
Change from baseline Maximum Inspiratory Pressure (MIP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.
Measured: Baseline and 6 weeks
Maximum Expiratory Pressure (MEP)
Change from baseline Maximum Expiratory Pressure (MEP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.
Measured: Baseline and 6 weeks
Functional capacity
Change from baseline functional capacity test at 6 weeks. Functional capacity will be assessed by the 6 minute walking test. The test will be performed according to American Thoracic Society (ATS) criteria. Patients will be allowed to rest for 10 minutes before the test. Heart rate, blood pressure, respiratory frequency, oxygen saturation, fatigue and dyspnea perception will be recorded before and after the test. Walking distance will be calculated.
Measured: Baseline and 6 weeks
Secondary outcomes (27)
Forced Vital Capacity (FVC)
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 6 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Baseline and 6 weeks
Forced Expiratory Volume 1 second (FEV1)
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function . FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Baseline and 6 weeks
Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)
Change from baseline FEV1 / FVC in respiratory function test at 6 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Baseline and 6 weeks
Forced Expiratory flow from between 25% to 75% of Vital Capacity (FMF 25-75)
Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity .
FMF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Baseline and 6 weeks
Peak flow rate (PEF)
Change from baseline Peak flow rate (PEF) in respiratory function test at 6 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Baseline and 6 weeks
Dyspnea
Change from baseline Dyspnea score of Medical Research Council (MRC) at 6 weeks.
It will be evaluated by MRC.
Measured: Baseline and 6 weeks
Peripheral muscle strength
Change from baseline peripheral muscle strength at 6 weeks. Lower extremity will be evaluated by 'sit to stand' test. Upper extremity will be evaluated by 'handgrip test'.
Measured: Baseline and 6 weeks
Maximal exercise capacity
Change from baseline treadmill test at 6 weeks. It will be evaluated by treadmill test.
Measured: Baseline and 6 weeks
Physical Activity
Change from baseline physical activity scores at 6 weeks. International Physical Activity Questionnaire (IPAQ) - Short Form (Turkish version of scale ).This questionnaire assesses, in minutes, the physical activity performed by the volunteers during the period of one week. The IPAQ considered all activities carried out by the volunteer (e.g. leisure, sport, exercise, and activities at home or in the garden). According to the responses, the volunteer is considered very active, active, irregularly active or sedentary, according to the intensity and time of the exercises practiced over the last week.
Measured: Baseline and 6 weeks
Quality of life level
Change from baseline quality of life scores at 6 weeks. Short Form (SF-36) Health Survey (Turkish version of scale) The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning (10 items) social functioning (2 items) role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items). For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
Measured: Baseline and 6 weeks
Depression level
Change from baseline depression scores at 6 weeks. Beck Depression questionnaire will be administered. The Beck Depression Questionnaire is an assessment scale that determines the risk of depression and the level of depressive symptoms and the measure of change in severity. It consists of 21 items. It provides 4 types of measurements. Each question contains 4 options. Each item gets a progressive score between 0-3 and the total score is obtained by their aggregation. The total varies from 0 to 63 points. Higher scores indicate higher depression.
Measured: Baseline and 6 weeks
Evaluation of sleep quality
Change from baseline evaluation of sleep quality scores at 6 weeks.The Pittsburgh Sleep Quality Index (PSQI) assess sleep quality. It consists of seven subscales: subjective sleep efficiency, sleep latency, sleep duration, sleep quality, sleep disturbance, sleep medication use, and daytime dysfunction due to sleepiness. Subscales yield a score from 0 to 3 and PSQI total score of >5 is indicative of poor sleep.
Measured: Baseline and 6 weeks
Anthropometric measurements
Change from baseline anthropometric measurements at 6 weeks. Waist, hip and abdominal circumference measurements will be assessed.The skinfold thickness will be measured with the skinfold caliper. These measurements will be made from specific measurement sites of chest, biceps, triceps, subscapular, abdominal, suprailiac, quadriceps, gastrocnemius.
Measured: Baseline and 6 weeks
Evaluation of fasting blood glucose in blood biochemistry
Change from baseline fasting blood glucose measurements at 6 weeks. The blood glucose concentration in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of High Density Lipoprotein in blood biochemistry
Change from baseline High Density Lipoprotein measurements at 6 weeks. The High Density Lipoprotein in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of Low Density Lipoprotein in blood biochemistry
Change from baseline Low Density Lipoprotein measurements at 6 weeks. The Low Density Lipoprotein in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of triglyceride in blood biochemistry
Change from baseline triglyceride measurements at 6 weeks. The triglyceride in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of C-Reactive Protein (CRP) in blood biochemistry
Change from baseline C-Reactive Protein (CRP) measurements at 6 weeks. The C-Reactive Protein (CRP) in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of sedimentation in blood biochemistry
Change from baseline sedimentation measurements at 6 weeks. The sedimentation in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of Antistreptolysin O (ASO) in blood biochemistry
Change from baseline Antistreptolysin O (ASO) measurements at 6 weeks. The Antistreptolysin O (ASO) in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of Creatine phosphokinase (CPK) in blood biochemistry
Change from baseline Creatine phosphokinase (CPK) measurements at 6 weeks. The Creatine phosphokinase (CPK) in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of Thyroid-Stimulating Hormone (TSH) in blood biochemistry
Change from baseline Thyroid-Stimulating Hormone (TSH) measurements at 6 weeks. The Thyroid-Stimulating Hormone (TSH) in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of Brain Natriuretic Peptide (Pro-BNP) in blood biochemistry
Change from baseline Brain Natriuretic Peptide (Pro-BNP) measurements at 6 weeks. The Brain Natriuretic Peptide (Pro-BNP) in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of complete blood count in blood biochemistry
Change from baseline complete blood count measurements at 6 weeks. The complete blood count in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of ferritin in blood biochemistry
Change from baseline ferritin measurements at 6 weeks. The ferritin in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of uric acid in blood biochemistry
Change from baseline uric acid measurements at 6 weeks. The uric acid in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Evaluation of creatinine in blood biochemistry
Change from baseline creatinine measurements at 6 weeks. The creatinine in blood biochemistry will be assessed.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start15 Apr 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Kıymet Muammer, MSc PT, Istanbul Medipol University Hospital
- Investigators
- Kıymet Muammer, MSc PT, Principal investigator, Istanbul University Cardiology Institute, Department of Physiotherapy and RehabilitationFatma Karantay Mutluay, Professor, Study director, Medipol University, Health Sciences Faculty, Physiotherapy and RehabilitationRengin Demir, Professor, Study chair, Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation,Alev Arat Özkan, Professor, Study chair, Istanbul University Cardiology Institute,Catheter Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523026
- Sponsor's protocol ID
- Kıymet Muammer
- Status last verified
- Sep 2018
- First submitted
- 14 Apr 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muammer K, Mutluay F, Demir R, Ozkan AA. Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial. Respir Med. 2020 Oct;172:106119. doi: 10.1016/j.rmed.2020.106119. Epub 2020 Aug 22.
PubMed 32877886
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Peripheral and Respiratory Muscle Training in Coronary Artery Patients With Metabolic Syndrome: A Randomized, Prospective, Double-Blind and Controlled Trial
- ClinicalTrials.gov ID
- NCT03523026
- Acronym / sponsor ID
- Kıymet Muammer
- Conditions
- Metabolic Syndrome, Coronary Artery Disease
- Keywords
- Metabolic Syndrome, Coronary Artery Patients, Neuromuscular Electrical Stimulation, Respiratory Muscle Training, Peripheral Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 14 May 2018 (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 this study is to investigate the effects of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in coronary artery patients with metabolic syndrome. Prospectively, randomly, double-blind, and controlled study. Stable coronary artery patients with metabolic syndrome will be included to the study from the Istanbul University Cardiology Institute clinic. Patients will be randomized into 3 groups; Neuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training Group (n: 20): 3 days per week for 6 weeks duration. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.Inspirator Muscle Training (IMT) and peripheral muscle training Group (n: 20): IMT will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator. Training intensity will set at 30% of the maximum inspiratory pressure.Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks. Peripheral Muscle Training Group (n: 20): Exercise will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.Parameters will be recorded before and after training. Evaluation parameters:Demographic and anthropometric measurements, respiratory function test,respiratory muscle strength,dyspnea, peripheral muscle strength, 6 minutes walking test, physical activity, quality of life, depression, sleep quality and laboratory evaluation.
Detailed description
Metabolic syndrome (MS) is a fatal endocrinopathy that appears with insulin resistance and is associated with systemic disorders such as abdominal obesity, glucose intolerance or diabetes mellitus, dyslipidemia, hypertension and coronary artery disease (CAD). The metabolic syndrome, which is regarded as an important public health problem in the world, shows a global increase.
Studies have showed that increased risk for cardiopulmonary disease is associated with people with metabolic syndrome. In the treatment of cardiopulmonary risk factors, therapeutic lifestyle changes and exercise are recommended in primary care strategy. Exercise training programs have been found to have positive effects on cardiopulmonary and metabolic parameters.It has been shown that respiratory functions are also adversely affected in these patients. In patients with metabolic syndrome, FEV1 and FVC were found to be influenced by decreased respiratory function and restrictive ventilation impairment.
Decreased respiratory functions and physical activity in patients with Metabolic Syndrome accompanied by multifactorial risks and complications will adversely affect quality of life. There are no studies in the literature that investigate the effects of peripheral and respiratory muscle training in patients with Metabolic Syndrome. Therefore, we aimed to investigate the effect of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in patients with Metabolic Syndrome. This study also aimed to contribute to the international literature by applying respiratory muscle training in patients with coronary artery disease with metabolic syndrome. In addition, in clinically structured rehabilitation programs, in coronary artery disease patients with metabolic syndrome will be provided with a questioning of the importance of respiratory muscle training.
The study will be planned as prospective, randomized, double blind and controlled. Access to the patients will be provided through an archive of patient records and a screening through the online system of the outpatient clinic. Before and after the training patients' effort tests and biochemical tests will be requested. Evaluations before and after the training will be done by another physiotherapist. The study will be conducted prospectively, randomly, double-blind, and controlled. Patients will be randomized into 3 groups.
NMES and Peripheral Muscle Training Group (n: 20).
IMT and Peripheral Muscle Training Group (n: 20),
Peripheral Muscle Training Group (n = 20).
NMES and Peripheral Muscle Training Group: NMES to rectus abdominis will be applied using 4 carbon silicon electrode. In the first sessions, patients ECG will be checked. Patients will be in semi-fowler position (30º),with their lower limbs to be in extension and upper limbs at their sides. The NMES frequency will be at 30 Hertz and the application time will be 30 minutes. Treatment will be programmed for 3 days per week. The patients will coordinate their breath (inspiration) with the contraction which will be generated by the electrical current. Peripheral muscle training will also be given. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.
IMT and Peripheral Muscle Training Group: IMT will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator. Training intensity will set at 30% of the maximum inspiratory pressure. Peripheral muscle training will also be given. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.
Peripheral Muscle Training Group: Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.
The rehabilitation program duration will be 6 weeks in all groups. Changes in parameters will be analyzed before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMES and Peripheral Muscle Training | Experimental | Device: Neuromuscular Electrical Stimulation, Other: Peripheral Muscle TrainingNeuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training NMES frequency will be 30 Hertz and the application time will be 30 minutes.Treatment will be programmed for 3 days per week. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks. |
| IMT and Peripheral Muscle Training | Experimental | Other: Inspirator Muscle Training, Other: Peripheral Muscle TrainingInspirator Muscle Training (IMT) and Peripheral Muscle Training IMT will be applied 7 days per week, twice a day for 15 minutes. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week. The program will continue for 6 weeks. |
| Peripheral Muscle Training | Experimental | Other: Peripheral Muscle TrainingPeripheral Muscle Training Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable coronary artery disease with metabolic syndrome diagnosis
- The ejection fraction(EF) = % 40 and EF >% 40,
- Participation to the study will be in a voluntary basis
Key exclusion criteria (9 listed)
- Over 80 years,
- EF <40% or New York Heart Association (NYHA) class III-IV
- Chronic obstructive pulmonary disease (COPD) and respiratory tract infection,
- Documented diagnosis of pulmonary, neurological,orthopedic, renal, hepatic, gastrointestinal, endocrine, oncologic
- New or suspected thromboembolic events
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 |
|---|---|---|
| Neuromuscular Electrical StimulationNeuromuscular Electrical Stimulation(NMES) to rectus abdominis will be applied using 4 carbon silicon electrode. In the first sessions, patients ECG will be checked. Patients will be in semi-fowler position (30º),with their lower limbs to be in extension and upper limbs at their sides. The NMES frequency will be at 30 Hertz and the application time will be 30 minutes. Treatment will be programmed for 3 days per week. The patients will coordinate their breath (inspiration) with the contraction which will be generated by the electrical current. The program will continue for 6 weeks. | Device | NMES and Peripheral Muscle Training |
| Inspirator Muscle TrainingInspirator Muscle Training(IMT) will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator.Training intensity will set at 30% of the maximum inspiratory pressure. | Other | IMT and Peripheral Muscle Training |
| Peripheral Muscle TrainingPeripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks. | Other | IMT and Peripheral Muscle Training, NMES and Peripheral Muscle Training, Peripheral Muscle Training |
Primary outcome
Maximum Inspiratory Pressure (MIP)
Time frame: Baseline and 6 weeks
Change from baseline Maximum Inspiratory Pressure (MIP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.
Maximum Expiratory Pressure (MEP)
Time frame: Baseline and 6 weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.
Functional capacity
Time frame: Baseline and 6 weeks
Change from baseline functional capacity test at 6 weeks. Functional capacity will be assessed by the 6 minute walking test. The test will be performed according to American Thoracic Society (ATS) criteria. Patients will be allowed to rest for 10 minutes before the test. Heart rate, blood pressure, respiratory frequency, oxygen saturation, fatigue and dyspnea perception will be recorded before and after the test. Walking distance will be calculated.
27 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Baseline and 6 weeks
Forced Expiratory Volume 1 second (FEV1)
Time frame: Baseline and 6 weeks
Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)
Time frame: Baseline and 6 weeks
Forced Expiratory flow from between 25% to 75% of Vital Capacity (FMF 25-75)
Time frame: Baseline and 6 weeks
Peak flow rate (PEF)
Time frame: Baseline and 6 weeks
Dyspnea
Time frame: Baseline and 6 weeks
Peripheral muscle strength
Time frame: Baseline and 6 weeks
Maximal exercise capacity
Time frame: Baseline and 6 weeks
Physical Activity
Time frame: Baseline and 6 weeks
Quality of life level
Time frame: Baseline and 6 weeks
Depression level
Time frame: Baseline and 6 weeks
Evaluation of sleep quality
Time frame: Baseline and 6 weeks
Anthropometric measurements
Time frame: Baseline and 6 weeks
Evaluation of fasting blood glucose in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of High Density Lipoprotein in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of Low Density Lipoprotein in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of triglyceride in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of C-Reactive Protein (CRP) in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of sedimentation in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of Antistreptolysin O (ASO) in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of Creatine phosphokinase (CPK) in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of Thyroid-Stimulating Hormone (TSH) in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of Brain Natriuretic Peptide (Pro-BNP) in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of complete blood count in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of ferritin in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of uric acid in blood biochemistry
Time frame: Baseline and 6 weeks
Evaluation of creatinine in blood biochemistry
Time frame: Baseline and 6 weeks
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 29 Jan 2019.
- Derived from this study: PubMed 32877886Muammer K, Mutluay F, Demir R, Ozkan AA. Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial. Respir Med. 2020 Oct;172:106119. doi: 10.1016/j.rmed.2020.106119. Epub 2020 Aug 22.
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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.
Kıymet Muammer, MSc PT principal investigator
Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation
Fatma Karantay Mutluay, Professor study director
Medipol University, Health Sciences Faculty, Physiotherapy and Rehabilitation
Rengin Demir, Professor study chair
Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation, Inspirator Muscle Training and Peripheral Muscle Training in people with Metabolic Syndrome and Coronary Artery Disease, run by Istanbul Medipol University Hospital 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 9 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 29 Jan 2019. 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?
Maximum Inspiratory Pressure (MIP) (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523026, which also lists 1 linked publication.
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 29 Jan 2019.