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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Other: Cardio-oncology program

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cancer AnswerLine; Phone Number: 1-800-865-1125; Email: CancerAnswerLine@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Rogel Cancer Center
      • Principal Investigator: Salim Hayek
      • Contact: Cancer AnswerLine; Phone Number: 800-865-1125; Email: CancerAnswerLine@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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.	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.	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.	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	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	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	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	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	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	8 weeks post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	8 weeks post enrollment

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Salim Hayek, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: UMCC 2023.004; HUM00223835 (Other Identifier: University of Michigan); U24HL157560 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No