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

NCT05945121 | Recruiting

• 3 other identifiers: UMCC 2023.004HUM00223835U24HL157560
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiovascular disease

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (4)

• Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.

  8 weeks post enrollment

• Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program

  8 weeks post enrollment

• Difference in biomarkers after an 8-week cardio-oncology prehabilitation program

  8 weeks post enrollment

• Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program

  8 weeks post enrollment

Study Arms (1)

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.

Other: Cardio-oncology program

Interventions

Cardio-oncology program OTHER

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)

Cardio-oncology program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Salim Hayek

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: July 14, 2023
• Study Start: August 25, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)