Recruiting

Prehabilitation Program

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT05945121

Conditions

Hematopoietic Stem Cell Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardio-oncology program

Study Details

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.

Conditions

Hematopoietic Stem Cell Transplant

Study ID

NCT05945121

Start date

Aug 25, 2023

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cardio-oncology program

The cardio-oncology program consists of a multimodal approach, which includes individualized exercise prescription following a detailed CV assessment and medical management of CV risk factors occurring over 8 weeks.

Interventions

Cardio-oncology program

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)

Primary outcome measure

  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data). [ Time Frame: 8 weeks post enrollment ]
  • Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction). [ Time Frame: 8 weeks post enrollment ]
  • Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in anaerobic threshold). [ Time Frame: 8 weeks post enrollment ]
  • Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in VO2peak). [ Time Frame: 8 weeks post enrollment ]
  • Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (comparison of V02 peak to predicted). [ Time Frame: 8 weeks post enrollment ]
  • Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER). [ Time Frame: 8 weeks post enrollment ]
  • Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (VE/VC02 slope). [ Time Frame: 8 weeks post enrollment ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

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

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

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

Principal Investigator:

Salim Hayek

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

May 4, 2026

Last verified

May, 2026

Keywords

  • Cardiovascular disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-05-04.