Improve Outcomes for Older Allogeneic Transplant Recipients

Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients

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.

Study Overview

• Status: Recruiting
• Conditions: Allogeneic Transplantation
• Intervention / Treatment: Behavioral: Exercise Program (Cohort A Prehab); Behavioral: Exercise Program (Cohort B Rehab)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqui Rick; Phone Number: 2152209675; Email: Jacqui.Rick@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine
      • Contact: Jacqui Rick; Phone Number: 215-220-9675; Email: Jacqui.Rick@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A (Prehab); 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.	Behavioral: Exercise Program (Cohort A Prehab); Pre-frail and frail potential HCT recipients 60 years and older will participate in a supervised exercise program from the time of enrollment up until HCT admission. Exercise compliance will be measured in part through physical activity trackers.from time of discharge from HCT until day +100 post-HCT. All HCT recipients 60 years and older will participate in a supervised exercise program from the time of discharge from HCT admission until day +100 post-HCT. Exercise compliance will be measured in part through physical activity trackers.
Experimental: Cohort B (Rehab); 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.	Behavioral: Exercise Program (Cohort B Rehab); All HCT recipients 60 years and older will participate in a supervised exercise program from the time of discharge from HCT admission until day +100 post-HCT. Exercise compliance will be measured in part through physical activity trackers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of enrolled subjects who participate in the supervised exercise program	From 3 months prior to HCT to 100 days after HCT
Median number of exercise sessions delivered pre-HCT and post-HCT.	From 3 months prior to HCT to 100 days after HCT

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital LOS for HCT	From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months
Rate of readmission	From time of discharge from initial hospital stay up through 1-2 years after HCT
6-month and 1-year overall mortality	From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS
1-year and 2-year OS	From day 0 of HCT to 1-year and 2-years
1-year and 2-year PFS	From day 0 of HCT to 1-year and 2-years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Shannon McCurdy, MD, Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UPCC 07422; Penn IRB# 851615 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No