Clinical trial NCT05945121: Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: Cardiovascular disease
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-07-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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.

Primary outcomes:
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data).
timeFrame: 8 weeks post enrollment
measure: Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction).
timeFrame: 8 weeks post enrollment
measure: Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in anaerobic threshold).
timeFrame: 8 weeks post enrollment
measure: Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in VO2peak).
timeFrame: 8 weeks post enrollment
measure: Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (comparison of V02 peak to predicted).
timeFrame: 8 weeks post enrollment
measure: Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER).
timeFrame: 8 weeks post enrollment
measure: Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (VE/VC02 slope).
timeFrame: 8 weeks post enrollment
Secondary outcomes:
measure: Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.
timeFrame: 8 weeks post enrollment
measure: Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program
timeFrame: 8 weeks post enrollment
measure: Difference in biomarkers after an 8-week cardio-oncology prehabilitation program
timeFrame: 8 weeks post enrollment
measure: Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program
timeFrame: 8 weeks post enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Salim Hayek
role: PRINCIPAL_INVESTIGATOR
References: