72 Participants Needed

Supervised Exercise for Transplant Recipients

JR
Overseen ByJacqui Rick
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abramson Cancer Center of the University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic HCT. The primary objective is to determine feasibility. Up to 60-72 evaluable subjects will be enrolled. Evaluable subjects are defined as those participating in the exercise intervention.

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 data supports the effectiveness of this treatment for transplant recipients?

Research shows that exercise programs can improve physical fitness, quality of life, and functional mobility in liver transplant recipients. Additionally, exercise is beneficial and feasible for heart transplant patients, enhancing their pulmonary function and functional capacity.12345

Is supervised exercise generally safe for transplant recipients?

Supervised exercise programs, like cardiac rehabilitation, are generally safe for patients, including those who have had heart transplants, as long as they are selected based on their physical and psychological conditions. However, patients at high risk, such as those with certain heart conditions, should be cautious and may need more careful monitoring during exercise.678910

How is the supervised exercise program treatment for transplant recipients different from other treatments?

The supervised exercise program for transplant recipients is unique because it focuses on structured physical activity to improve exercise capacity, muscle strength, and quality of life, which are not typically addressed by standard medical treatments. This program is tailored to the specific needs of transplant patients, offering both prehabilitation (before surgery) and rehabilitation (after surgery) to enhance recovery and reduce cardiovascular risks.1691112

Research Team

SM

Shannon McCurdy, MD

Principal Investigator

Penn Medicine

Eligibility Criteria

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

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

Treatment Details

Interventions

  • Exercise Program (Cohort A Prehab)
  • Exercise Program (Cohort B Rehab)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort B (Rehab)Experimental Treatment1 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 Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Exercise Training for Heart Transplant Patients.Roos, R.[2016]
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.
Quality of Life and Functional Mobility After Progressive Resistance Exercise in an Adolescent With a Liver Transplant.Burkhardt, JA., Rapport, MJK.[2021]
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.
Randomized and comparative study between two intra-hospital exercise programs for heart transplant patients.Kawauchi, TS., Almeida, PO., Lucy, KR., et al.[2016]

References

Exercise Training for Heart Transplant Patients. [2016]
Quality of Life and Functional Mobility After Progressive Resistance Exercise in an Adolescent With a Liver Transplant. [2021]
Randomized and comparative study between two intra-hospital exercise programs for heart transplant patients. [2016]
Patients' expectations and experiences of rehabilitation following lung transplantation. [2014]
A systematic review of prehabilitation programs in abdominal cancer surgery. [2022]
Cardiac rehabilitation programs. [2010]
Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]
Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]
Metabolic Profile and Myocardial Performance of Renal Transplant Recipients Participating in Unsupervised Physical Exercise as a Prescription Program. [2021]
Prehabilitation programs for cancer patients: a systematic review of randomized controlled trials (protocol). [2023]
The effects of exercise training in adult solid organ transplant recipients: A systematic review and meta-analysis. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Effect of high-volume and -intensity endurance training in heart transplant recipients. [2019]