Hematopoietic Stem Cell TransplantNCT05945121
Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing Cardio-oncology program in people with Hematopoietic Stem Cell Transplant, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- Cardio-oncology program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu
Salim Hayek
About this study
Official title: Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
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
- Being tested
- Cardio-oncology program
- Keywords
- Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-oncology programOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Cardio-oncology program | Experimental | 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. Receives: Other: Cardio-oncology program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
Percent of eligible participants who are screened and give informed consent
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).
percentage of enrolled participants who complete pre-post CV assessments
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
the number of participants recruited per month
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).
the average amount of time required for participants to complete initial and follow-up CV assessments
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
The percentage of days of exercised out of 24 days recommended over the 8 weeks for both aerobic and resistance activities.
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).
The average duration (min) of aerobic and resistance workouts over the course of the intervention.
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data).
the percentage of missing data from study questionnaires.
Measured: 8 weeks post enrollment
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction).
Assessed qualitatively with in-depth, semi-structured, one-to-one exit interviews with participants. A member of the research team experienced with telephone interviews, but not involved in intervention delivery, will contact all patients within 1 week after completion of the final follow-up assessment.The researcher will facilitate the interviews using a conversational-style approach whilst referring to a topic guide. Topics will focus on patients' perceived expectations, benefits, motives, and barriers to the program. The researcher will additionally ask questions regarding reasons for non-adherence to the exercise intervention, and reasons for dropout amongst discontinuing patients. The topic guide will be used flexibly to allow patients to raise additional issues which they consider important to the study. Interviews will be recorded with participants knowledge and then transcribed, coded, and assessed for relevant themes and recommendations using iterative thematic analysis
Measured: 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).
change in anaerobic threshold from pre to post intervention reported in L/min
Measured: 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).
change in VO2peak from pre to post intervention reported in ml/kg/min
Measured: 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).
Comparison of V02 peak assessed after intervention in comparison to the predicted values reported as the percent difference between the values
Measured: 8 weeks post enrollment
Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER).
change in RER (a ratio between cardiac dioxide output (VCO2)/oxygen uptake (VO2)) from pre to post intervention reported as the percent difference between the values
Measured: 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).
Change in VE/VC02 slope (defined as the change in minute ventilation per unit of carbon dioxide production) from pre to post intervention
Measured: 8 weeks post enrollment
Secondary outcomes (4)
Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.
Frequency and severity of cardiovascular symptoms (fatigue, shortness of breath, edema) will be assessed using the short Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health. Items are grouped into the four domains; Physical limitation, Symptom frequency, Quality of life, and Social limitation.
Measured: 8 weeks post enrollment
Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program
Overall quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Responses are given on a single-item ranging in score from 0 to 100. A high scale score represents a higher response level.
Measured: 8 weeks post enrollment
Difference in biomarkers after an 8-week cardio-oncology prehabilitation program
High-sensitivity troponin-I (RayBiotech), B-type natriuretic peptide (BNP) (RayBiotech), and soluble urokinase plasminogen activator receptor (suPAR) (Virogates) will be measured in residual serum samples collected as part of usual care using enzyme-linked immunosorbent assays.
Measured: 8 weeks post enrollment
Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program
We will calculate the percentage of participants evaluated who end up being eligible for HSCT and compare rates to the number of participants who are referred to cardio-oncology, do not receive the intervention, and are considered ineligible.
Measured: 8 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start25 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Salim Hayek, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945121
- Sponsor's protocol ID
- UMCC 2023.004
- Other IDs
- HUM00223835, U24HL157560
- Status last verified
- May 2026
- First submitted
- 4 May 2023
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05945121
- Acronym / sponsor ID
- UMCC 2023.004
- Conditions
- Hematopoietic Stem Cell Transplant
- Keywords
- Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardio-oncology program | Experimental | Other: Cardio-oncology programThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-oncology programConsented 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) | Other | Cardio-oncology program |
Primary outcome
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
Time frame: 8 weeks post enrollment
Percent of eligible participants who are screened and give informed consent
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).
Time frame: 8 weeks post enrollment
percentage of enrolled participants who complete pre-post CV assessments
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
Time frame: 8 weeks post enrollment
the number of participants recruited per month
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).
Time frame: 8 weeks post enrollment
the average amount of time required for participants to complete initial and follow-up CV assessments
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
Time frame: 8 weeks post enrollment
The percentage of days of exercised out of 24 days recommended over the 8 weeks for both aerobic and resistance activities.
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).
Time frame: 8 weeks post enrollment
The average duration (min) of aerobic and resistance workouts over the course of the intervention.
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data).
Time frame: 8 weeks post enrollment
the percentage of missing data from study questionnaires.
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction).
Time frame: 8 weeks post enrollment
Assessed qualitatively with in-depth, semi-structured, one-to-one exit interviews with participants. A member of the research team experienced with telephone interviews, but not involved in intervention delivery, will contact all patients within 1 week after completion of the final follow-up assessment.The researcher will facilitate the interviews using a conversational-style approach whilst referring to a topic guide. Topics will focus on patients' perceived expectations, benefits, motives, and barriers to the program. The researcher will additionally ask questions regarding reasons for non-adherence to the exercise intervention, and reasons for dropout amongst discontinuing patients. The topic guide will be used flexibly to allow patients to raise additional issues which they consider important to the study. Interviews will be recorded with participants knowledge and then transcribed, coded, and assessed for relevant themes and recommendations using iterative thematic analysis
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
change in anaerobic threshold from pre to post intervention reported in L/min
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
change in VO2peak from pre to post intervention reported in ml/kg/min
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
Comparison of V02 peak assessed after intervention in comparison to the predicted values reported as the percent difference between the values
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
change in RER (a ratio between cardiac dioxide output (VCO2)/oxygen uptake (VO2)) from pre to post intervention reported as the percent difference between the values
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
Change in VE/VC02 slope (defined as the change in minute ventilation per unit of carbon dioxide production) from pre to post intervention
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salim Hayek principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-oncology program in people with Hematopoietic Stem Cell Transplant, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate). (time frame: 8 weeks post enrollment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.