The Effects of Muscle Training in Coronary Artery Patients With Metabolic Syndrome

NCT03523026 | Completed

• 1 other identifier: Kıymet Muammer
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Coronary Artery Disease

Keywords

Metabolic Syndrome; Coronary Artery Patients; Neuromuscular Electrical Stimulation; Respiratory Muscle Training; Peripheral Muscle Training

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 6 weeks

Secondary Outcomes (27)

• Forced Vital Capacity (FVC)

  Baseline and 6 weeks

• Forced Expiratory Volume 1 second (FEV1)

  Baseline and 6 weeks

• Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)

  Baseline and 6 weeks

• Forced Expiratory flow from between 25% to 75% of Vital Capacity (FMF 25-75)

  Baseline and 6 weeks

• Peak flow rate (PEF)

  Baseline and 6 weeks

Study Arms (3)

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.

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.

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.

Other: Peripheral Muscle Training

Interventions

Neuromuscular Electrical Stimulation DEVICE

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.

NMES and Peripheral Muscle Training

Inspirator Muscle Training OTHER

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.

IMT and Peripheral Muscle Training

Peripheral Muscle Training OTHER

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; NMES and Peripheral Muscle Training; Peripheral Muscle Training

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Istanbul University: collaborator

Study Sites (1)

Kıymet Muammer

Istanbul, Fatih/Istanbul, 34096, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32877886 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kıymet Muammer, MSc PT

  Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Fatma Karantay Mutluay, Professor

  Medipol University, Health Sciences Faculty, Physiotherapy and Rehabilitation

  STUDY DIRECTOR

• Rengin Demir, Professor

  Istanbul University Cardiology Institute, Department of Physiotherapy and Rehabilitation,

  STUDY CHAIR

• Alev Arat Özkan, Professor

  Istanbul University Cardiology Institute,Catheter Laboratory

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: May 14, 2018
• Study Start: April 15, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 29, 2019

Record last verified: 2018-09

Locations

TU (1)