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Recruiting NCT05945121

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

No phase Interventional Hematopoietic Stem Cell Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardio-oncology program.
Who it may be relevant to
Registry conditions: Hematopoietic Stem Cell Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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 measures

  • 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]
Secondary outcome measures (4)
  • Symptom assessment scores after an 8-week cardio-oncology prehabilitation program. [Time frame: 8 weeks post enrollment]
  • Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program [Time frame: 8 weeks post enrollment]
  • Difference in biomarkers after an 8-week cardio-oncology prehabilitation program [Time frame: 8 weeks post enrollment]
  • Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program [Time frame: 8 weeks post enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Michigan Rogel Cancer Center — Ann Arbor

Identifiers

NCT: NCT05945121 · UMCC 2023.004 · HUM00223835 · U24HL157560

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗