NCT01606696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

May 24, 2012

Last Update Submit

July 15, 2015

Conditions

CAD

Keywords

CADcardiac rehabilitationfitness

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular fitness

    10 weeks

Study Arms (2)

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

HIITBEHAVIORAL

Higher intensity interval training.

HIIT
Standard intensity non-interval trainingBEHAVIORAL

Standard intensity non-interval training.

Standard intensity non-interval training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Study Officials

  • Steven J Keteyian, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

January 1, 2014

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

US(1)