RecruitingNot Applicable

Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation

United States10 participantsStarted 2023-08-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).

Timeframe: 8 weeks post enrollment

Trial details

NCT IDNCT05945121

SponsorUniversity of Michigan Rogel Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Cancer AnswerLine

1-800-865-1125 CancerAnswerLine@med.umich.edu

View on ClinicalTrials.gov More Hematopoietic Stem Cell Transplant trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).

Timeframe: 8 weeks post enrollment

Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).

Timeframe: 8 weeks post enrollment