Improve Outcomes for Older Allogeneic Transplant Recipients

NCT ID: NCT05612789

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2031-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Allogeneic Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Program (Cohort A Prehab)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Exercise Program (Cohort B Rehab)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon McCurdy, MD

Role: PRINCIPAL_INVESTIGATOR

Penn Medicine

Locations

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Penn Medicine

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacqui Rick

Role: CONTACT

2152209675

Facility Contacts

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Jacqui Rick

Role: primary

215-220-9675

Other Identifiers

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Penn IRB# 851615

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 07422

Identifier Type: -

Identifier Source: org_study_id

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