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Trial Title:
Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
NCT ID:
NCT05945121
Condition:
Hematopoietic Stem Cell Transplant
Conditions: Keywords:
Cardiovascular disease
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cardio-oncology program
Description:
Consented patients will undergo an initial CV evaluation as part of standard of care then
participate in an 8-week at-home, personalized exercise intervention followed by an
additional CV assessment prior to HSCT (after 8-weeks)
Arm group label:
Cardio-oncology program
Summary:
To assess the feasibility and preliminary effectiveness of a Cardio-Oncology
Prehabilitation program in patients at high-risk of developing Cardiovascular (CV) events
in improving Cardiorespiratory fitness (CRF) and reducing acute CV complications in
Hematopoietic stem cell transplant (HSCT) recipients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult 18 years or older
- Referred for HSCT evaluation
- Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia,
atrial fibrillation, obesity, heart failure, history of coronary artery disease,
diabetes)
- Able to ambulate unassisted
- Ability to understand and the willingness to sign a written informed consent
- Ability to use Polar Flow heart rate application
Exclusion Criteria:
- Severe anemia (hemoglobin <7 gm/dl)
- Untreated high-risk coronary artery disease (left main, triple vessel disease)
- Severe aortic stenosis
- Recent fracture as assessed via self-report
- Gross balance deficits
- Severe pain with basic movement
- Unable to ambulate unassisted or exercise
- NYHA class IV heart failure
- Adults unable to give consent, pregnant women, and prisoners are excluded from this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer AnswerLine
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Investigator:
Last name:
Salim Hayek
Email:
Principal Investigator
Start date:
August 25, 2023
Completion date:
August 2027
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Heart, Lung, and Blood Institute (NHLBI)
Agency class:
NIH
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05945121
