The Effects of Muscle Training in Coronary Artery Patients With Metabolic Syndrome
Condition: Metabolic Syndrome; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Metabolic Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Neuromuscular Electrical Stimulation; Inspirator Muscle Training; Peripheral Muscle Training
Intervention type(s): Device; Other; Other
Intervention description(s): 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 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 Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Coronary Artery Patients; Neuromuscular Electrical Stimulation; Respiratory Muscle Training; Peripheral Muscle Training