Higher Intensity Interval Training in Cardiac Rehabilitation | NCT01606696

Studies
Higher Intensity Interval Training in Cardiac Rehabilitation

NCT01606696

Sponsor

Henry Ford Health System

Status

Completed

Last Update Posted

Jul 16, 2015Estimated

Enrollment

49Actual

Phase

Not Applicable

Conditions

Interventions

HIIT
Standard intensity non-interval training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 24, 2012

First Submission Date that Met QC Criteria

May 25, 2012

First Posted Date

May 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2015

Last Update Posted Date

Jul 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIIT	Experimental	Higher intensity interval training.	Behavioral: HIIT
Standard intensity non-interval training	Active Comparator	Standard intensity non-interval training	Behavioral: Standard intensity non-interval training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIIT	Behavioral	Higher intensity interval training.	HIIT
Standard intensity non-interval training

Measure	Description	Time Frame
Cardiovascular fitness		10 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75 years
Male or female
Angiographic documentation of CAD

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven J Keteyian, PhD	Henry Ford Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Health System		Detroit	Michigan	48202	United States