NCT03523026

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

Completed NA Last updated 29 January 2019

What this trial tests

NA trial testing Neuromuscular Electrical Stimulation in Metabolic Syndrome in 60 participants. Completed in 30 December 2018.

Timeline

15 April 2018

Primary endpoint
30 November 2018

30 December 2018

Quick facts

Lead sponsor	Istanbul Medipol University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	15 April 2018
Primary completion	30 November 2018
Estimated completion	30 December 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Neuromuscular Electrical Stimulation
• Inspirator Muscle Training
• Peripheral Muscle Training

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Istanbul Medipol University Hospital

Who can join

Adults 35 to 80, any sex, with Metabolic Syndrome or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial.
   Muammer K, Mutluay F, Demir R, Özkan AA. · · 2020 · cited 5× · PMID 32877886 · DOI 10.1016/j.rmed.2020.106119