NCT02796365

Brief Summary

The purpose of this study is to identify patients at risk for future heart failure using novel markers of early cardiac damage and determine if exercise training can improve these emerging markers as well as overall fitness and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

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

First Submitted

Initial submission to the registry

April 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

April 29, 2016

Last Update Submit

December 12, 2018

Conditions

Doxorubicin Induced CardiomyopathyBreast CancerGastric CancerLeukemia

Keywords

ExerciseCancerCardiotoxicityCardiomyopathyCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Left ventricular strain

    Spectral Doppler measure with General Electric software analysis of global longitudinal strain.

    12 weeks

Secondary Outcomes (5)

  • Peak VO2

    12 weeks

  • Percent body fat

    12 weeks

  • Isokinetic strength

    12 weeks

  • Quality of life

    12 weeks

  • Cardiac Troponin

    12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Patients will participate in a 10 week outpatient cardiac rehabilitation program. Exercise will consist of 3 days per week of interval training on a treadmill or bike at an intensity between 50-90% of heart rate reserve. Additionally patients will perform resistance exercises 1-2 days per week and attend 8 nutrition and lifestyle classes.

Other: Exercise

Usual care

NO INTERVENTION

Control group will not be instructed on exercise, but encouraged to follow standard medical advice.

Interventions

ExerciseOTHER

Intervention will include 10 weeks of a standard cardiac rehabilitation program consisting of thrice a week aerobic exercise and 1-2 days per week resistance exercises.

Exercise

Eligibility Criteria

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

You may qualify if:

  • Patients with cancer who are undergoing or have completed the chemotherapy drugs doxorubicin and/or trastuzumab.
  • Have had a recent echocardiogram with a relative reduction in LV strain of \>10%.
  • If no recent echocardiogram, have a troponin value \>0.04 ng/mL, or an increase of 0.04 ng/mL if baseline troponin is elevated.
  • Age \>/= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) scale 0-2.
  • Males and females.

You may not qualify if:

  • Patients with an Ejection Fraction \<50%
  • Patients not deemed appropriate by a cardiologist or oncologist
  • Patients with an ECOG scale \>2
  • Inability to perform exercise
  • Patients who already report exercising \>2days per week for \>29 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Clay Ford Center for Athletic Medicine

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Kerrigan DJ, Reddy M, Walker EM, Cook B, McCord J, Loutfi R, Saval MA, Baxter J, Brawner CA, Keteyian SJ. Cardiac Rehabilitation Improves Fitness in Patients With Subclinical Markers of Cardiotoxicity While Receiving Chemotherapy: A RANDOMIZED CONTROLLED STUDY. J Cardiopulm Rehabil Prev. 2023 Mar 1;43(2):129-134. doi: 10.1097/HCR.0000000000000719. Epub 2022 Aug 4.

    PMID: 35940850DERIVED

MeSH Terms

Conditions

Breast NeoplasmsStomach NeoplasmsLeukemiaMotor ActivityNeoplasmsCardiotoxicityCardiomyopathies

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesBehaviorHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bioscientific Staff

Study Record Dates

First Submitted

April 29, 2016

First Posted

June 10, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)