HIIT Versus IMT on Modulating Blood Rheology in CAD Risk Factors

April 13, 2018 updated by: Rana Elbanna, Cairo University

High Intensity Interval Training Versus Inspiratory Muscle Training on Modulating Blood Rheology in Coronary Artery Disease Risk Factors

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Oman
    • Al Dhahra
      • Ibri, Al Dhahra, Oman, 511
        • Recruiting
        • Ibri hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
the participant will do a program of inspiratory muscle training for 10-15 minutes once daily using Threshold Inspiration Muscle Training Device
Device: Threshold Inspiration Muscle Training Device
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.
Other Names:
  • respironics,cedarGrove,NJ 07009-1201 Made in U.S.A
Experimental: Group B
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
Device: Electronic Bicycle Ergometer
Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be used in High interval intensity training.
Other Names:
  • Biodex LBC, made in New York

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: after 4 weeks of the trial application
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
after 4 weeks of the trial application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter
after 4 weeks of the trial application
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
Time Frame: after 4 weeks of the trial application
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
after 4 weeks of the trial application
Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
Time Frame: after 4 weeks of the trial application
Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)
after 4 weeks of the trial application
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
Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter
after 4 weeks of the trial application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Rana H Elbanna, master, lecturer assistance at faculty of physical therapy at Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

April 25, 2018

Study Completion (Anticipated)

May 3, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rana Elbanna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease, Early-Onset

Clinical Trials on Threshold Inspiration Muscle Training Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe