CADHIITNCT01606696
Higher Intensity Interval Training in Cardiac Rehabilitation
A study testing HIIT and Standard intensity non-interval training in people with CAD, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect higher intensity interval exercise (HIIT) with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CAD
- What is being tested?
- HIIT and Standard intensity non-interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Male or female
- Angiographic documentation of CAD
Who cannot join
- Unstable angina pectoris
- MI / PCI < 3 weeks
- CABG < 4weeks
- Exercise induced ischemia > 1mm ST depression
- LVEF < 40%
- complex ventricular arrhythmias or atrial fibrillation
- orthopedic limitations to treadmill exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practical Use of Higher Intensity Interval Exercise in Cardiac Rehabilitation to Improve Aerobic Fitness
The purpose of this study is to compare the effect higher intensity interval exercise (HIIT) with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.
- Conditions
- CAD
- Being tested
- HIIT, Standard intensity non-interval training
- Keywords
- CAD, cardiac rehabilitation, fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
Higher intensity interval training.
Standard intensity non-interval trainingBehavioural
Standard intensity non-interval training.
| Study group | Role | What they receive |
|---|---|---|
| HIIT | Experimental | Higher intensity interval training. Receives: Behavioral: HIIT |
| Standard intensity non-interval training | Active comparator | Standard intensity non-interval training Receives: Behavioral: Standard intensity non-interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular fitness
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven J. Keteyian, Henry Ford Health System
- Investigators
- Steven J Keteyian, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606696
- Sponsor's protocol ID
- HFHS-PC-HIIT
- Acronym
- HIIT
- Status last verified
- Jul 2015
- First submitted
- 24 May 2012
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Use of Higher Intensity Interval Exercise in Cardiac Rehabilitation to Improve Aerobic Fitness
- ClinicalTrials.gov ID
- NCT01606696
- Acronym / sponsor ID
- HIIT / HFHS-PC-HIIT
- Conditions
- CAD
- Keywords
- CAD, cardiac rehabilitation, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 May 2012 (estimated)
- 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.
The purpose of this study is to compare the effect higher intensity interval exercise (HIIT) with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT | Experimental | Behavioral: HIITHigher intensity interval training. |
| Standard intensity non-interval training | Active comparator | Behavioral: Standard intensity non-interval trainingStandard intensity non-interval training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Male or female
- Angiographic documentation of CAD
Key exclusion criteria (7 listed)
- Unstable angina pectoris
- MI / PCI < 3 weeks
- CABG < 4weeks
- Exercise induced ischemia > 1mm ST depression
- LVEF < 40%
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 |
|---|---|---|
| HIITHigher intensity interval training. | Behavioural | HIIT |
| Standard intensity non-interval trainingStandard intensity non-interval training. | Behavioural | Standard intensity non-interval training |
Primary outcome
Cardiovascular fitness
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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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.
Steven J Keteyian, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and Standard intensity non-interval training in people with CAD, run by Henry Ford Health System at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jul 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular fitness (time frame: 10 weeks). 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 16 Jul 2015.