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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Conditions

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