Improve Outcomes for Older Allogeneic Transplant Recipients

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Allogeneic Transplantation

Treatments: Behavioral: Exercise Program (Cohort B Rehab); Behavioral: Exercise Program (Cohort A Prehab)

Study type: Interventional

Funder types: Other

Identifiers

NCT05612789

Penn IRB# 851615 (Other Identifier)

UPCC 07422

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cohort A (Prehab)

1. Age 60 years or older.
2. Planned allogeneic HCT in the next 1-6 months.
3. Hematological malignancy as the indication for HCT.
4. Pre-frail or frail by Fried frailty phenotype.

Cohort B (Rehab)

1. Age 60 years or older.
2. Planned allogeneic HCT or HCT within the last 30 days.
3. Hematological malignancy as the indication for HCT.

Exclusion criteria

Cohorts A and B

1. Comorbid disability or illness that prevents safe exercise.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Cohort A (Prehab)

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Program (Cohort A Prehab)

Cohort B (Rehab)

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Program (Cohort B Rehab)