Prehabilitation Program for High-Risk Hematopoietic Stem Cell Transplant Patients
This study is testing an 8-week at-home, personalized exercise program called a "Cardio-oncology program" for people who are at high risk for heart problems and are going to have a hematopoietic stem cell transplant (HSCT). The program aims to improve your heart and lung fitness and reduce heart-related complications after your transplant. To join, you must be 18 or older, referred for HSCT, have at least one heart risk factor (like high blood pressure or diabetes), and be able to walk without help. Researchers will measure how easy it is to recruit and keep people in the program. The study is currently unclear on its status and plans to enroll 10 participants.
- Study design
- This is an interventional study with no specified phase, planning to enroll 10 participants.
- What's involved
- You would have an initial heart evaluation, participate in an 8-week at-home exercise program, and then have another heart evaluation before your transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals are measured at 8 weeks post enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Salim Hayek · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).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).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).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).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).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).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).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).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).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).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).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).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).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