NCT03438968

Brief Summary

Cardiovascular disease (CVD) is highly prevalent in women resulting in 398,086 deaths annually. Even as women participate in traditional CR programs, data specificity and subsequent research have yet to emerge in a meaningful way so that women-centered CR can be better customized and their outcomes properly assessed. Aerobic fitness is a powerful predictor of prognosis in individuals with CVD yet there is evidence that women do not improve their peak VO2 as much as men during CR. We have designed a training program for women based upon past research with a goal of optimizing their training potential in CR. This program combines the utilization of a training technique termed high intensity interval training along with specific strength training exercises of the upper legs. We hypothesize that women, irrespective of age, would be capable of high intensity interval training to improve peak aerobic capacity in the CR setting. Furthermore, since women often have a deficit of thigh strength entering CR, and thigh strength correlates with endurance walking,strength training will also be included. The purpose of this study is to examine the value of high intensity interval training and strength training to maximize aerobic training response in CR for women. This may contribute to establishing specific protocols and training guidelines for future program design for women in CR. Since a set of comprehensive CR guidelines pertaining to women is lacking, it is hoped that the results of this study will help us develop exercise protocols and regimen to better structure and modulate CR programs for optimal benefit to women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

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 24, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 13, 2018

Last Update Submit

February 13, 2018

Conditions

Exercise TrainingCoronary Artery DiseaseWomenCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Aerobic Fitness

    Peak VO2 measured with cardiopulmonary exercise testing

    4-month study participation

Study Arms (2)

High-Intensity aerobic training

EXPERIMENTAL

Individuals will exercise using a high-intensity interval exercise training protocol

Behavioral: Exercise training

Standard Moderate continuous training

ACTIVE COMPARATOR

Individuals will exercise using a standard moderate intensity continuous exercise training protocol

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

Cardiac Rehabilitation exercise training

High-Intensity aerobic trainingStandard Moderate continuous training

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05401, United States

RECRUITING

Related Publications (1)

  • Khadanga S, Savage PD, Pecha A, Rengo J, Ades PA. Optimizing Training Response for Women in Cardiac Rehabilitation: A Randomized Clinical Trial. JAMA Cardiol. 2022 Feb 1;7(2):215-218. doi: 10.1001/jamacardio.2021.4822.

    PMID: 34817540DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Philip A Ades, MD

CONTACT

802 847 4514philip.ades@uvmhealth.org

Sherrie Khadanga, MD

CONTACT

802 847 3734Sherrie.Khadanga@uvmhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
At stress testing, cardiologist will not know group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

August 24, 2017

Primary Completion

December 31, 2018

Study Completion

April 30, 2019

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

US(1)