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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03506984
Study type Interventional
Source Cairo University
Contact Rana H Elbanna, master
Phone 00201120636626
Email rana.elbanna@yahoo.com
Status Recruiting
Phase N/A
Start date September 1, 2017
Completion date May 3, 2018