Supervised Exercise for Transplant Recipients

Overseen By Jacqui Rick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Comorbid disability, illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supervised exercise program can benefit individuals undergoing allogeneic HCT, a type of bone marrow transplant. The study consists of two parts: one for participants who begin exercising before their transplant and another for those who start after their initial hospital stay. The goal is to determine if these exercise programs are feasible and beneficial for patients. This trial may suit individuals aged 60 or older with blood cancer, planning for a transplant soon, and experiencing increased difficulty with everyday activities. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance recovery and quality of life for future transplant patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a supervised exercise program for transplant recipients.

What prior data suggests that this exercise program is safe for transplant recipients?

Research shows that exercise programs are generally safe for individuals who have undergone a hematopoietic stem cell transplant (HSCT). Studies have found that these activities can improve physical health without causing harm. For example, one study found that supervised exercise programs, similar to those in cardiac rehabilitation, are well-tolerated even by individuals with serious health conditions, such as heart transplants.

Other research confirms that exercise is safe for HSCT recipients and can enhance physical abilities and overall quality of life. Additionally, evidence indicates that exercise is not only safe but also beneficial for individuals with blood-related cancers.

In summary, these findings suggest that participating in a supervised exercise program with professional guidance is safe and beneficial for transplant recipients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how tailored exercise programs can benefit transplant recipients before and after their procedures. Unlike typical recovery protocols that might not emphasize structured physical activity, this trial investigates supervised exercise both as a preparatory step (Prehab) and as rehabilitation (Rehab) after transplant. The Prehab program aims to strengthen patients even before they undergo hematopoietic cell transplantation (HCT), potentially improving outcomes. Meanwhile, the Rehab program focuses on maintaining and enhancing physical function post-transplant, especially in older adults. By examining these structured exercise regimens, researchers hope to uncover new ways to boost recovery and quality of life for transplant patients.

What evidence suggests that this exercise program is effective for transplant recipients?

Research has shown that exercise programs can greatly enhance fitness and quality of life for transplant recipients. One study found that patients in these programs improved their fitness levels by 16% to 25%. In this trial, participants will be divided into two cohorts: Cohort A (Prehab) and Cohort B (Rehab). Cohort A will engage in a supervised exercise program before their hematopoietic stem cell transplant (HSCT), while Cohort B will begin their exercise program after discharge from their initial hospital stay for HSCT. Exercise also reduces tiredness and enhances overall well-being. For patients who have undergone an HSCT, exercise helps maintain physical activity and may improve survival chances post-transplant. Strength training, in particular, prevents muscle loss and reduced activity. Overall, evidence supports that exercise positively impacts recovery and quality of life for transplant recipients. ^{2 3 6 7 8}

Who Is on the Research Team?

Shannon McCurdy, MD

Principal Investigator

Penn Medicine

Are You a Good Fit for This Trial?

This trial is for older adults (60+) who are either pre-frail or frail and are planning to undergo or have undergone an allogeneic hematopoietic cell transplant (HCT) due to a blood cancer. Participants will be split into two groups: one that starts the exercise program before HCT and another that begins after HCT.

Inclusion Criteria

I am 60 or older, planning a stem cell transplant due to blood cancer, and considered pre-frail or frail.

I am 60 or older, had or planning a stem cell transplant for blood cancer.

Exclusion Criteria

Cohorts A and B: Comorbid disability or illness that prevents safe exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Pre-frail and frail subjects attend at least twice weekly exercise sessions with a physical therapist and complete an exercise program at home prior to admission for HCT

4-6 weeks

At least 2 visits per week (in-person)

Rehabilitation

All patients 60 years and older attend at least weekly exercise sessions with a physical therapist and complete an exercise program at home through Day +100 after HCT

14 weeks

At least 1 visit per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Program (Cohort A Prehab)
• Exercise Program (Cohort B Rehab)

Trial Overview The study is testing if a supervised exercise program can improve health outcomes for those receiving allogeneic HCT. It's a pilot study, meaning it's preliminary research to see if the idea is feasible. Subjects will be divided into two cohorts based on when they start exercising relative to their transplant procedure.

How Is the Trial Designed?

Group I: Cohort B (Rehab) Experimental Treatment 1 Intervention

All patients 60 years and older upon discharge from their initial hospital stay for HCT will attend at least weekly exercise sessions with a physical therapist and be given an exercise program to complete at home with sessions continued through Day +100 after HCT.

Group II: Cohort A (Prehab) Experimental Treatment 1 Intervention

Pre-frail and frail subjects will attend at least twice weekly exercise sessions with a physical therapist and be given an exercise program to complete at home prior to admission for HCT. Patients enrolled in this cohort can continue on to Cohort B.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

Cardiac rehabilitation programs are generally safe and effective for improving the functional activities of patients with cardiac disease, but not all patients require supervised rehabilitation, especially those who were active before their cardiac event.

High-risk patients with low functional capacities (3-5 METs) benefit the most from rehabilitation, while low-risk patients (7-9 METs) may not need the program, indicating that rehabilitation should be tailored based on individual physical and psychological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation programs. Hotta, SS.[2010]

Eighteen lung transplant recipients, averaging 52 years old, participated in a qualitative study that highlighted their strong desire to regain normalcy in daily life through supervised exercise rehabilitation, which they found essential for their recovery.

The study revealed that group exercise sessions provided motivation and peer support, significantly enhancing the rehabilitation experience, although some patients faced limitations due to pre-existing or postoperative health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' expectations and experiences of rehabilitation following lung transplantation. Fuller, LM., Button, B., Tarrant, B., et al.[2014]

This systematic review aims to evaluate the benefits and harms of prehabilitation programs, primarily focused on physical exercise, for cancer patients compared to standard care, highlighting the potential for improved clinical outcomes such as aerobic capacity and reduced postoperative complications.

The review will utilize rigorous methods, including independent screening of studies and quality assessments, to ensure reliable results that can guide healthcare providers and patients in making informed decisions about prehabilitation in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for cancer patients: a systematic review of randomized controlled trials (protocol). Meneses-Echávez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

Heart transplant recipients (HTR) can successfully engage in high-volume and high-intensity exercise training, achieving exercise performance levels comparable to or even exceeding those of sedentary healthy subjects (SHS).

The study showed that the endurance training group (HTR-ET) had significantly higher exercise performance metrics, including VO2max and lactate levels, compared to other HTR groups, indicating that intensive training can enhance physical capabilities post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-volume and -intensity endurance training in heart transplant recipients. Pokan, R., Von Duvillard, SP., Ludwig, J., et al.[2019]

Exercise training significantly improves exercise capacity (measured as VO2 peak) and quadriceps muscle strength in solid organ transplant recipients, with a moderate effect size based on a systematic review of 29 studies.

Participants who engaged in exercise training also reported better health-related quality of life and improvements in diastolic blood pressure, highlighting the importance of incorporating exercise into post-transplant care despite some concerns about study bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exercise training in adult solid organ transplant recipients: A systematic review and meta-analysis. Janaudis-Ferreira, T., Tansey, CM., Mathur, S., et al.[2021]

An exercise program designed for cardiac transplant patients in England has been shown to be feasible, meaning that patients can successfully participate in it.

The program is considered beneficial, suggesting that exercise may improve health outcomes for cardiac transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Heart Transplant Patients. Roos, R.[2016]

Both exercise programs for heart transplant patients led to significant improvements in pulmonary function and functional capacity, indicating that physical therapy is beneficial in the postoperative period.

There was no significant difference in outcomes between the standard routine exercise program and the new training protocol, suggesting that any structured exercise can enhance recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized and comparative study between two intra-hospital exercise programs for heart transplant patients. Kawauchi, TS., Almeida, PO., Lucy, KR., et al.[2016]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

A 6-month unsupervised home exercise program for 30 renal transplant recipients led to significant improvements in myocardial performance, particularly in ejection fraction (EF), indicating enhanced heart function.

While the lipid profile remained stable and within a low-risk range, the study suggests that regular moderate-intensity exercise can help maintain cardiovascular health in renal transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Profile and Myocardial Performance of Renal Transplant Recipients Participating in Unsupervised Physical Exercise as a Prescription Program. Moscarelli, L., Sofi, F., Mascherini, G., et al.[2021]

Prehabilitation programs for patients undergoing major abdominal cancer surgery include a mix of exercise, nutritional, and psychological interventions, but their composition and delivery methods vary widely across studies, indicating a need for standardization.

In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care, suggesting that while prehabilitation may optimize recovery, its impact on reducing complications needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. Hijazi, Y., Gondal, U., Aziz, O.[2022]

Progressive resistance exercise (PRE) was effective in improving strength, endurance, and overall quality of life in an adolescent following a liver transplant, as demonstrated over a 20-week outpatient physical therapy program.

The intervention led to measurable improvements in functional mobility and fitness levels, suggesting that PRE-based training can be a beneficial rehabilitation strategy for adolescents post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Functional Mobility After Progressive Resistance Exercise in an Adolescent With a Liver Transplant. Burkhardt, JA., Rapport, MJK.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012812/

IMPROVE-BMT: A Pilot Randomized Controlled Trial of ... Overall, exercise adherence across all patients, regardless of transplant type, was high at an average of 91.98% (SD = 34.59), ranging from 33% ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0181313

Randomized controlled trial on the effects of a supervised high ... Median improvements in physical fitness ranged between 16 and 25% in the intervention group and between 12 and 19% in the control group. Fatigue decreased in ...

3. withpower.com withpower.com/trial/phase-allogeneic-transplantation-10-2022-e99a1

Supervised Exercise for Transplant Recipients Research shows that exercise programs can improve physical fitness, quality of life, and functional mobility in liver transplant recipients. Additionally, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208125001494

Effectiveness of Physical Exercise on Hematopoietic Stem ... Physical exercise benefits HSCT patients by improving quality of life and reducing fatigue. Evidence quality is moderate to critically low, requiring cautious ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3721148/

Exercise in Patients Receiving Hematopoietic Stem Cell ... Strength training may be an effective intervention to alleviate problems with decreased physical activity, reduced muscle mass, and fatigue in HSCT recipients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05612789

Improve Outcomes for Older Allogeneic Transplant ... This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing ...

7. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(24)00138-7/fulltext

the Active Care after Transplantation (ACT) multicentre ... Safety outcomes showed no safety concerns. After 3 months of supervised exercise intervention, HRQoL-domain physical functioning improved in ...

8. nature.com nature.com/articles/s41598-023-49420-7

Prehabilitative high-intensity interval training and ... Evidence suggests that exercise interventions in patients with haematological cancer are safe and beneficial.