HIIT Versus IMT on Modulating Blood Rheology in CAD Risk Factors
Primary Purpose
Coronary Artery Disease, Early-Onset
Status
Unknown status
Phase
Not Applicable
Locations
Oman
Study Type
Interventional
Intervention
Threshold Inspiration Muscle Training Device
Electronic Bicycle Ergometer
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease, Early-Onset
Eligibility Criteria
Inclusion Criteria:
- They will be 45-55 years old participants of males.
- All of them had body mass index more than 30 kg/m2.
- All of them were diagnosed as diabetic persons for at least 5 years.
- All of them were diagnosed as a mild to moderate hypertensive persons for at least 5 years.
- All of them had a reduction in walking capacity in relation to their height, age and body mass index (BMI).
Exclusion Criteria:
- Unstable cardiac condition.
- Patient who were on beta blocker.
- Uncontrolled diabetes mellitus.
- Mentally unstable person.
- Patient with intermittent claudication.
Sites / Locations
- Ibri hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
the participant will do a program of inspiratory muscle training for 10-15 minutes once daily using Threshold Inspiration Muscle Training Device
the participant will start cycling slowly for five minutes without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down using Electronic Bicycle Ergometer
Outcomes
Primary Outcome Measures
Compare between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating lipid profile ( cholesterol level mg/dl, triglyceride mg/dl, LDL mg/dl and HDL mg/dl) by using the blood analyzer in CAD risk factors
Comparison between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating lipid profile which composed of ( cholesterol level mg/dl, triglyceride mg/dl, LDL mg/dl and HDL mg/dl) by using the blood analyzer (Photometer, 5010, boehinger) in Coronary Artery Disease risk factors
Secondary Outcome Measures
Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter
Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter
Compare between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating hematocrit value by using the blood analyzer in CAD risk factors
Comparison between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating hematocrit value (The proportion of the blood that consists of packed red blood cells) % by using the blood analyzer (Photometer, 5010, boehinger) in Coronary Artery Disease risk factors
Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter
Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03506984
Brief Title
HIIT Versus IMT on Modulating Blood Rheology in CAD Risk Factors
Official Title
High Intensity Interval Training Versus Inspiratory Muscle Training on Modulating Blood Rheology in Coronary Artery Disease Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 25, 2018 (Anticipated)
Study Completion Date
May 3, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Participants had randomly divided into two equal groups. Group (A) had received a program of high intensity interval training 30-40 minutes three times per week for one month. The participant will start cycling slowly for five minute without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down. Group (B) will receive a program of inspiratory muscle training by using the threshold based inspiratory muscle trainer for 10-15 minute daily with frequency three times per week for four weeks.
Detailed Description
Training Procedure for group (A):
Each participant had signed a consent form after receiving a detailed explanation about the procedure.
BMI had been measured body weight(Kg) and height (m2)
a. BMI= body weight (Kg)/ height (m2).
Resting pulse rate had been measured to the participant three successive times then the mean had to be taken.
A blood sample had been taken by a nurse in a heparinized tube and delivered to lab within six hours.
The participant had been asked to walk as quickly as he could in a 30-meter pre-measured flat walking area with interval markings every three meters for six minutes. Cones or brightly colored tape to mark boundaries of the walkway with cones placed at the beginning and end of the 30-meter boundary to indicate turns. (Actual distance). (BALKE 1963)
Teaching the participant had been reached how to perform high interval training exercise.
The load had been determined according to maximum heart rate obtained from cardiopulmonary exercise testing performed by cardiologist.
high intensity (85% - 95% MHR) and the interval period (60% - 75% MHR) .(Gibala et al. 2006)
The participant's started by five minutes warming up on the bicycle ergometer with no resistance as shown in fig (8).
Then one minute of high intensity training followed by one and half minute of low intensity training for 20 to 30 minutes.
Finally, a five minutes of cooling down with no resistance had performed.
Post treatment evaluation had been done using step three, four and step five.
Training Procedure for group (B):
Each participant had signed a consent form after receiving a detailed explanation about the procedure.
BMI had been measured body weight(Kg) and height (m2)
a. BMI= body weight (Kg)/ height (m2).
Resting pulse rate had been measured to the participant three successive times then the mean had to be taken.
A blood sample had been taken by a nurse in a heparinized tube and delivered to lab within six hours.
The participant had been asked to walk as quickly as he could in a 30-meter pre-measured flat walking area with interval markings every three meters for six minutes. Cones or brightly colored tape to mark boundaries of the walkway with cones placed at the beginning and end of the 30-meter boundary to indicate turns. (Actual distance). (BALKE 1963)
Teaching the participant had been teached how to use the threshold based Inspiratory muscle trainer device.
The load had been determined according to 10 maximum repetitions (10RMax).
The intensity had been 60% to 80% of the participant's maximal effort.(Enright & Unnithan 2011)
The Inspiratory Muscle Trainer had been applied for (10 to 15) minutes once daily with frequency three times per week for four weeks as shown in fig (9).
Post treatment evaluation had been done using step three, four and step five.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Early-Onset
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will randomely divided into two equal groups. Group (A) will receive a programe of high intensity interval training 30-40 minutes three times per week for one month.the participant will start cycling slowly for five minute without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down. The participant will be closely monitored by the handheld telemetry. Group (B) will receive a program of inspiratory muscle training by using the threshold based inspiratory muscle trainer for 10-15 minutesonce daily with frequency three times per week for four weeks.
Masking
Participant
Masking Description
the participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
the participant will do a program of inspiratory muscle training for 10-15 minutes once daily using Threshold Inspiration Muscle Training Device
Arm Title
Group B
Arm Type
Experimental
Arm Description
the participant will start cycling slowly for five minutes without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down using Electronic Bicycle Ergometer
Intervention Type
Device
Intervention Name(s)
Threshold Inspiration Muscle Training Device
Other Intervention Name(s)
respironics,cedarGrove,NJ 07009-1201 Made in U.S.A
Intervention Description
Threshold based trainer is a small handled device.It includes a mouthpiece and a calibrated spring loaded valve. The valve control a constant inspiratory pressure training load and the patient must generate a suffient inspiratory pressure in order for the inspiratory valve to be opened and allow the air to be inhaled. The amount of resistance can be adjusted by varying the compression of the spring-loaded valve. Adjustment from 9cmH2o to 41cmH2o.
Intervention Type
Device
Intervention Name(s)
Electronic Bicycle Ergometer
Other Intervention Name(s)
Biodex LBC, made in New York
Intervention Description
Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be used in High interval intensity training.
Primary Outcome Measure Information:
Title
Compare between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating lipid profile ( cholesterol level mg/dl, triglyceride mg/dl, LDL mg/dl and HDL mg/dl) by using the blood analyzer in CAD risk factors
Description
Comparison between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating lipid profile which composed of ( cholesterol level mg/dl, triglyceride mg/dl, LDL mg/dl and HDL mg/dl) by using the blood analyzer (Photometer, 5010, boehinger) in Coronary Artery Disease risk factors
Time Frame
after 4 weeks of the trial application
Secondary Outcome Measure Information:
Title
Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter
Description
Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter
Time Frame
after 4 weeks of the trial application
Title
Compare between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating hematocrit value by using the blood analyzer in CAD risk factors
Description
Comparison between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating hematocrit value (The proportion of the blood that consists of packed red blood cells) % by using the blood analyzer (Photometer, 5010, boehinger) in Coronary Artery Disease risk factors
Time Frame
after 4 weeks of the trial application
Title
Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
Description
Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
Time Frame
after 4 weeks of the trial application
Title
Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter
Description
Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter
Time Frame
after 4 weeks of the trial application
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
They will be 45-55 years old participants of males.
All of them had body mass index more than 30 kg/m2.
All of them were diagnosed as diabetic persons for at least 5 years.
All of them were diagnosed as a mild to moderate hypertensive persons for at least 5 years.
All of them had a reduction in walking capacity in relation to their height, age and body mass index (BMI).
Exclusion Criteria:
Unstable cardiac condition.
Patient who were on beta blocker.
Uncontrolled diabetes mellitus.
Mentally unstable person.
Patient with intermittent claudication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana H Elbanna, master
Phone
00201120636626
Email
rana.elbanna@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif O Elabd, master
Phone
0096891107871
Email
shiref.osama@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rana H Elbanna, master
Organizational Affiliation
lecturer assistance at faculty of physical therapy at Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ibri hospital
City
Ibri
State/Province
Al Dhahra
ZIP/Postal Code
511
Country
Oman
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M Habib, master
Phone
0096899575015
Email
dpthabib@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided
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HIIT Versus IMT on Modulating Blood Rheology in CAD Risk Factors
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