Clinical trial NCT03506984: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease, Early-Onset
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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):

1. Each participant had signed a consent form after receiving a detailed explanation about the procedure.
2. BMI had been measured body weight(Kg) and height (m2)

   a. BMI= body weight (Kg)/ height (m2).
3. Resting pulse rate had been measured to the participant three successive times then the mean had to be taken.
4. A blood sample had been taken by a nurse in a heparinized tube and delivered to lab within six hours.
5. 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)
6. Teaching the participant had been reached how to perform high interval training exercise.
7. The load had been determined according to maximum heart rate obtained from cardiopulmonary exercise testing performed by cardiologist.
8. high intensity (85% - 95% MHR) and the interval period (60% - 75% MHR) .(Gibala et al. 2006)
9. The participant's started by five minutes warming up on the bicycle ergometer with no resistance as shown in fig (8).
10. Then one minute of high intensity training followed by one and half minute of low intensity training for 20 to 30 minutes.
11. Finally, a five minutes of cooling down with no resistance had performed.
12. Post treatment evaluation had been done using step three, four and step five.

Training Procedure for group (B):

1. Each participant had signed a consent form after receiving a detailed explanation about the procedure.
2. BMI had been measured body weight(Kg) and height (m2)

   a. BMI= body weight (Kg)/ height (m2).
3. Resting pulse rate had been measured to the participant three successive times then the mean had to be taken.
4. A blood sample had been taken by a nurse in a heparinized tube and delivered to lab within six hours.
5. 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)
6. Teaching the participant had been teached how to use the threshold based Inspiratory muscle trainer device.
7. The load had been determined according to 10 maximum repetitions (10RMax).
8. The intensity had been 60% to 80% of the participant's maximal effort.(Enright \& Unnithan 2011)
9. 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).
10. Post treatment evaluation had been done using step three, four and step five.

Eligibility criteria: Inclusion Criteria:

1. They will be 45-55 years old participants of males.
2. All of them had body mass index more than 30 kg/m2.
3. All of them were diagnosed as diabetic persons for at least 5 years.
4. All of them were diagnosed as a mild to moderate hypertensive persons for at least 5 years.
5. All of them had a reduction in walking capacity in relation to their height, age and body mass index (BMI).

Exclusion Criteria:

1. Unstable cardiac condition.
2. Patient who were on beta blocker.
3. Uncontrolled diabetes mellitus.
4. Mentally unstable person.
5. Patient with intermittent claudication.

Primary outcomes:
measure: 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
timeFrame: after 4 weeks of the trial application
Secondary outcomes:
measure: Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter
timeFrame: after 4 weeks of the trial application
measure: 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
timeFrame: after 4 weeks of the trial application
measure: Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
timeFrame: after 4 weeks of the trial application
measure: Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter
timeFrame: after 4 weeks of the trial application
Other outcomes:
Locations:
city: Ibri
country: Oman
facility: Ibri hospital
state: Al Dhahra
Study officials:
affiliation: lecturer assistance at faculty of physical therapy at Cairo University
name: Rana H Elbanna, master
role: PRINCIPAL_INVESTIGATOR
References: