]>
IRCT20190702044075N1 IRCT 2019-12-27 Shiraz University Evaluating the Effects of 6-weeks Interval Aerobic Exercise and Respiratory Muscle Training on some of Cardiopulmonary and Muscular Indicators of Chronic Obstructive Pulmonary Disease Patients COPD Evaluating the Effects of 6-weeks Interval Aerobic Exercise and Respiratory Muscle Training on some of Cardiopulmonary and Muscular Indicators of Chronic Obstructive Pulmonary Disease Patients (Case Study). 2019-11-11 anticipated 5 Complete https://irct.ir/trial/40651 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A Chronic Obstructive Pulmonary Disease. Intervention group: The intervention group will include 5 COPD patients at Stage 3 & 4. First, Informed consent form will be provided for Participants and will be completed by Patient or in the case of necessity, with the supervision of the witness or legal guardian of the patient. then the patients will participate in two pre-test and post-test steps. to determine peak exercise capacity and cardio-respiratory fitness (CRF), or the risk of heart disease and the hidden ischemia; Cardio Pulmonary Exercise Testing and the health screening tests before activity based on the American College of Sports Medicine (ACSM) guidelines, will be taken with supervision of Sports medicine physician. Pulmonary function tests (PFTs) will be done at the hospital or Medical center. Muscle functional tests ( Muscular strength and endurance, Body Composition, and flexibility) will be done In partnership with Nursing staff In the Sports Science department laboratory. After completing the above steps, Patients will take part in the 6-week exercise rehab intervention, 3 days per week; Including the interval aerobic exercise and inspiratory muscle training (IMT). 24 to 48 hours after the end of the Exercise intervention, the above mentioned tests will be carried out as a post-test to assess the changes and adaptations created in the pulmonary, cardiac and muscular indicators. Interval aerobic exercise program; will be performed as walking or cycling on a treadmill or cycle ergometer. during this period; Heart rate and ECG, Arterial oxygen saturation percentage (SaO2), and blood pressure will be monitored using the Vital signs monitor and Pulse Oximeter. the intensity of the aerobic exercise program: 30 to 40% (low intensity) and 60 to 80% (high intensity) peak heart rate achieved during cardiopulmonary exercise testing. the high-intensity stage time is 2 minute and the low-intensity stage is 3 minutes. Interval exercise time for the first and second weeks, 20 minutes; Third and fourth weeks, 25 minutes; and the fifth and sixth weeks, will be 30 minutes. Inspiratory muscle training (IMT) program: 3 days per week with the 30% of maximal inspiratory pressure (MIP) resulted from plethysmography test, for 15 minutes per session using inspiratory muscle training device POWERbreathe™. duration of each training session respectively in the first and second weeks 50 minutes, 3rd and 4th weeks 55 minutes, and in the 5th and 6th weeks will be 60 minutes.. Yes - There is a plan to make this available What will be shared: The results of primary and secondary outcomes will be shared. When: two months after the publication of the results. To whom: academic researchers. Conditions: Once accessed, individuals have the right to use the study protocol for rehabilitation purposes. Where to obtain: Mr. Mohammad Amin Bahrami will be responsive through email: aminjoangamper@gmail.com‏ How to obtain: After receiving the request and mentioning the reasons for data requirement, will be answered within a maximum of one month. Comments:
public Dr. Mohammad Javad Fallahi
Department of Internal Medicine, Namazi Hospital, Namazi Square, Shiraz.
Shiraz Iran (Islamic Republic of) 71936-13311 +98 71 3647 4332 fallahimj@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mohammad Javad Fallahi
Department of Internal Medicine, Namazi Hospital, Namazi Square, Shiraz.
Shiraz Iran (Islamic Republic of) 71936-13311 +98 71 3647 4332 fallahimj@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic Obstructive Pulmonary Disease Stage 3 and 4 18 years no limit Both Uncontrolled cardiovascular disease ( decompensated CHF, uncontrolled arrhythmia, myocardial infarction or unstable angina during recent 6 weeks) uncontrolled hypertension (systolic blood pressure more than 180 mm-Hg / diastolic blood pressure more than 110 mm Hg) any musculo-skeletal disease and Motor restriction which preclude exercise program moderate to severe COPD exacerbation leading to hospital admission during recent 6 weeks performing regular exercise or participation in cardiac or pulmonary rehabilitation during recent 6 months J44.9 Chronic obstructive pulmonary disease, unspecified Rehabilitation Intervention group: The intervention group will include 5 COPD patients at Stage 3 & 4. First, Informed consent form will be provided for Participants and will be completed by Patient or in the case of necessity, with the supervision of the witness or legal guardian of the patient. then the patients will participate in two pre-test and post-test steps. to determine peak exercise capacity and cardio-respiratory fitness (CRF), or the risk of heart disease and the hidden ischemia; Cardio Pulmonary Exercise Testing and the health screening tests before activity based on the American College of Sports Medicine (ACSM) guidelines, will be taken with supervision of Sports medicine physician. Pulmonary function tests (PFTs) will be done at the hospital or Medical center. Muscle functional tests ( Muscular strength and endurance, Body Composition, and flexibility) will be done In partnership with Nursing staff In the Sports Science department laboratory. After completing the above steps, Patients will take part in the 6-week exercise rehab intervention, 3 days per week; Including the interval aerobic exercise and inspiratory muscle training (IMT). 24 to 48 hours after the end of the Exercise intervention, the above mentioned tests will be carried out as a post-test to assess the changes and adaptations created in the pulmonary, cardiac and muscular indicators. Interval aerobic exercise program; will be performed as walking or cycling on a treadmill or cycle ergometer. during this period; Heart rate and ECG, Arterial oxygen saturation percentage (SaO2), and blood pressure will be monitored using the Vital signs monitor and Pulse Oximeter. the intensity of the aerobic exercise program: 30 to 40% (low intensity) and 60 to 80% (high intensity) peak heart rate achieved during cardiopulmonary exercise testing. the high-intensity stage time is 2 minute and the low-intensity stage is 3 minutes. Interval exercise time for the first and second weeks, 20 minutes; Third and fourth weeks, 25 minutes; and the fifth and sixth weeks, will be 30 minutes. Inspiratory muscle training (IMT) program: 3 days per week with the 30% of maximal inspiratory pressure (MIP) resulted from plethysmography test, for 15 minutes per session using inspiratory muscle training device POWERbreathe™. duration of each training session respectively in the first and second weeks 50 minutes, 3rd and 4th weeks 55 minutes, and in the 5th and 6th weeks will be 60 minutes. FEV₁ (Forced Expiratory Volume in the first Second): is the volume of air that can forcibly be blown out in the first second, after full inspiration. In another words, this indicator shows the volume of expiratory air in the first second of vital capacity. (Vital Capacity; The maximum volume of air that can be blown out after a very deep inspiration). Timepoint: Before and after the 6th and final week of the intervention, as a Pulmonary Function Test (PFT). Method of measurement: Using spirometry, measured in Liters. FVC (Forced vital capacity): is the volume of air that can be blown out of the lungs with more intensity and maximum power, after full inspiration. Timepoint: Before and after the 6th and final week of the intervention, as a Pulmonary Function Test (PFT). Method of measurement: Using spirometry, measured in Liters. TLC (Total lung capacity): is the maximum volume of air that can be placed in the lungs and is about 5800 ml. Timepoint: Before and after the 6th and final week of the intervention, as a Pulmonary Function Test (PFT). Method of measurement: Using Plethysmograph or "body box", measured in Liters. RV (Residual volume): the volume of air remaining in the lungs at the end of a very deep exhalation. Timepoint: Before and after the 6th and final week of the intervention, as a Pulmonary Function Test (PFT). Method of measurement: Using Plethysmograph or "body box", measured in Liters. FRC (Functional Residual Capacity): The volume of air that remains in the lungs after a normal exhalation, when the lungs and chest are resting. Timepoint: Before and after the 6th and final week of the intervention, as a Pulmonary Function Test (PFT). Method of measurement: Using Plethysmograph or "body box" or Indirect spirometry with helium dilution method, measured in Liters. HRR index ( Heart rate recovery ): Is the rate of return heart rate to rest mode In the first minute after stopping exercise, Which reflects the reactivation of the parasympathetic system, and a delay in its decline indicates impaired cardiac function. Timepoint: Before and after the 6th and final week of the intervention; 1 minute after the end of the exercise test. Method of measurement: Usin the Electrocardiography or Polar™ Heart rate sensor. RPP index (Rate Pressure Product): Indicates the amount of internal Cardiac muscle work and it's used to showing the workload and oxygen consumption of myocardium, and obtained by multiplying the systolic blood pressure in the heart rate. [RPP = SBP × HR/1000]. Timepoint: Before and after the 6th and final week of the intervention; Immediately upon stopping the cardiac exercise (stress) testing. Method of measurement: Using the Sphygmomanometer and Electrocardiography or Polar™ Heart rate sensor. CRF (Cardio respiratory Fitness): Refers to the capacity of the respiratory and cardiovascular systems to provide muscles oxygen during sustained or intense exercise. Timepoint: Before and after the 6th and final week of the intervention; during exercise testing. Method of measurement: Using gas analyzer and Calculating Vo2max. Muscle strength: refers to the ability of the muscle to generate the force (power). Timepoint: Before and after the 6th and final week of the intervention. Method of measurement: Using hand grip or handheld dynamo meter. Muscle endurance: Refers to the ability of the muscle to maintain or repeat a particular task over time. Timepoint: Before and after the 6th and final week of the intervention. Method of measurement: Using Sit-up and Inverted Row (Supine row) tests. Flexibility index: The Level of ability to move or mobilize a joint around its entire range of motion and maintaining it facilitates joint movements. Timepoint: Before and after the 6th and final week of the intervention. Method of measurement: Using sit and reach test. Body composition: It means the ratio of fat (adipose) tissue to free fat tissue and percentage of muscle mass. Timepoint: Before and after the 6th and final week of the intervention. Method of measurement: Using body composition analyzer. Shiraz University Approved 2019-05-15 Ethics Committee of Shiraz University of Medical Sciences Vice-Chancellor for Research, Central building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)