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 range18 Years

SexALL

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.

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

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

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 range18 Years

SexALL

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

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

Timeframe: 8 weeks post enrollment