Coronary Artery Disease, Early-OnsetNCT03506984
HIIT Versus IMT on Modulating Blood Rheology in CAD Risk Factors
A study testing Threshold Inspiration Muscle Training Device and Electronic Bicycle Ergometer in people with Coronary Artery Disease, Early-Onset, run by Cairo University at 1 site in Oman.
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… Read more about this study
- Who is it for?
- Ages 45 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Early-Onset
- What is being tested?
- Threshold Inspiration Muscle Training Device and Electronic Bicycle Ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteOman
- Study dates
- 1 Sep 2017to 3 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Unstable cardiac condition.
- Patient who were on beta blocker.
- Uncontrolled diabetes mellitus.
- Mentally unstable person.
- Patient with intermittent claudication.
Trial locations and contacts
1 site in 1 country.
Oman1 site, 1 recruiting
- Recruiting
Ibri hospital
Ibri, Al Dhahra, 511
Mohamed M Habib, master, 0096899575015, dpthabib@gmail.com
About this study
Official title: 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.
Read the 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)
- 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)
- 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.
- Conditions
- Coronary Artery Disease, Early-Onset
- Being tested
- Threshold Inspiration Muscle Training Device, Electronic Bicycle Ergometer
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold Inspiration Muscle Training DeviceDevice
Also called respironics,cedarGrove,NJ 07009-1201 Made in U.S.A
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.
Electronic Bicycle ErgometerDevice
Also called Biodex LBC, made in New York
Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be used in High interval intensity training.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | the participant will do a program of inspiratory muscle training for 10-15 minutes once daily using Threshold Inspiration Muscle Training Device Receives: Device: Threshold Inspiration Muscle Training Device |
| Group B | Experimental | 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 Receives: Device: Electronic Bicycle Ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 4 weeks of the trial application
Secondary outcomes (4)
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
Measured: 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
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
Measured: after 4 weeks of the trial application
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)
Measured: after 4 weeks of the trial application
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
Measured: after 4 weeks of the trial application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Sep 2017
- Primary completion25 Apr 2018 (estimated)
- Study completion3 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease, Early-OnsetStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elbanna, Cairo University
- Investigators
- Rana H Elbanna, master, Principal investigator, lecturer assistance at faculty of physical therapy at Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506984
- Sponsor's protocol ID
- Rana Elbanna
- Status last verified
- Apr 2018
- First submitted
- 15 Mar 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training Versus Inspiratory Muscle Training on Modulating Blood Rheology in Coronary Artery Disease Risk Factors
- ClinicalTrials.gov ID
- NCT03506984
- Acronym / sponsor ID
- Rana Elbanna
- Conditions
- Coronary Artery Disease, Early-Onset
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Apr 2018 (estimated)
- Study completion
- 3 May 2018 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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)
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Threshold Inspiration Muscle Training Devicethe participant will do a program of inspiratory muscle training for 10-15 minutes once daily using Threshold Inspiration Muscle Training Device |
| Group B | Experimental | Device: Electronic Bicycle Ergometerthe 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 |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- Unstable cardiac condition.
- Patient who were on beta blocker.
- Uncontrolled diabetes mellitus.
- Mentally unstable person.
- Patient with intermittent claudication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold Inspiration Muscle Training DeviceAlso: respironics,cedarGrove,NJ 07009-1201 Made in U.S.AThreshold 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. | Device | Group A |
| Electronic Bicycle ErgometerAlso: Biodex LBC, made in New YorkElectronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be used in High interval intensity training. | Device | Group B |
Primary outcome
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
4 secondary outcomes
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
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
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 modified BORG scale by meter
Time frame: after 4 weeks of the trial application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: Undecided. not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana H Elbanna, master principal investigator
lecturer assistance at faculty of physical therapy at Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold Inspiration Muscle Training Device and Electronic Bicycle Ergometer in people with Coronary Artery Disease, Early-Onset, run by Cairo University at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana H Elbanna, master (00201120636626, rana.elbanna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: after 4 weeks of the trial application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.