Clinical trial NCT03523026: The Effects of Muscle Training in Coronary Artery Patients With Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Coronary Artery Disease
Keywords: Metabolic Syndrome
Coronary Artery Patients
Neuromuscular Electrical Stimulation
Respiratory Muscle Training
Peripheral Muscle Training
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2018-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Stable coronary artery disease with metabolic syndrome diagnosis
2. The ejection fraction(EF) = % 40 and EF \>% 40,
3. Participation to the study will be in a voluntary basis

Exclusion Criteria:

1. Over 80 years,
2. EF \<40% or New York Heart Association (NYHA) class III-IV
3. Chronic obstructive pulmonary disease (COPD) and respiratory tract infection,
4. Documented diagnosis of pulmonary, neurological,orthopedic, renal, hepatic, gastrointestinal, endocrine, oncologic
5. New or suspected thromboembolic events
6. Severe refractory hypertension
7. Acute myocardial infarction and pulmonary edema in the last 6 months,
8. Coronary artery revascularization attempts (percutaneous transluminal coronary angioplasty and coronary artery bypass surgery) and previous valve surgery in the last 6 months,
9. Cardiac pacemaker

Primary outcomes:
measure: Maximum Inspiratory Pressure (MIP)
timeFrame: Baseline and 6 weeks
measure: Maximum Expiratory Pressure (MEP)
timeFrame: Baseline and 6 weeks
measure: Functional capacity
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline and 6 weeks
measure: Forced Expiratory Volume 1 second (FEV1)
timeFrame: Baseline and 6 weeks
measure: Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)
timeFrame: Baseline and 6 weeks
measure: Forced Expiratory flow from between 25% to 75% of Vital Capacity (FMF 25-75)
timeFrame: Baseline and 6 weeks
measure: Peak flow rate (PEF)
timeFrame: Baseline and 6 weeks
measure: Dyspnea
timeFrame: Baseline and 6 weeks
measure: Peripheral muscle strength
timeFrame: Baseline and 6 weeks
measure: Maximal exercise capacity
timeFrame: Baseline and 6 weeks
measure: Physical Activity
timeFrame: Baseline and 6 weeks
measure: Quality of life level
timeFrame: Baseline and 6 weeks
measure: Depression level
timeFrame: Baseline and 6 weeks
measure: Evaluation of sleep quality
timeFrame: Baseline and 6 weeks
measure: Anthropometric measurements
timeFrame: Baseline and 6 weeks
measure: Evaluation of fasting blood glucose in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of High Density Lipoprotein in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of Low Density Lipoprotein in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of triglyceride in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of C-Reactive Protein (CRP) in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of sedimentation in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of Antistreptolysin O (ASO) in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of Creatine phosphokinase (CPK) in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of Thyroid-Stimulating Hormone (TSH) in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of Brain Natriuretic Peptide (Pro-BNP) in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of complete blood count in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of ferritin in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of uric acid in blood biochemistry
timeFrame: Baseline and 6 weeks
measure: Evaluation of creatinine in blood biochemistry
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kıymet Muammer
state: Fatih/Istanbul
Study officials:
affiliation: Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation
name: Kıymet Muammer, MSc PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University, Health Sciences Faculty, Physiotherapy and Rehabilitation
name: Fatma Karantay Mutluay, Professor
role: STUDY_DIRECTOR
affiliation: Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation,
name: Rengin Demir, Professor
role: STUDY_CHAIR
affiliation: Istanbul University Cardiology Institute,Catheter Laboratory
name: Alev Arat Özkan, Professor
role: STUDY_CHAIR
References:
citation: 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.