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NCT Number: NCT05612789

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.

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Key information

Conditions

Allogeneic Transplantation

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Jacqui Rick

CONTACT

[email protected]

215-220-9675

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort A (Prehab)

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

Cohort B (Rehab)

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

Exclusion criteria

Cohorts A and B

  • Comorbid disability or illness that prevents safe exercise.

Treatment and study plan

Exercise Program (Cohort A Prehab)

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.

Exercise Program (Cohort B Rehab)

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.

Primary outcomes

  1. Proportion of enrolled subjects who participate in the supervised exercise program

    Time frame: From 3 months prior to HCT to 100 days after HCT

  2. Median number of exercise sessions delivered pre-HCT and post-HCT.

    Time frame: From 3 months prior to HCT to 100 days after HCT

Secondary outcomes

  1. Hospital LOS for HCT

    Time frame: From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months

  2. Rate of readmission

    Time frame: From time of discharge from initial hospital stay up through 1-2 years after HCT

  3. 6-month and 1-year overall mortality

    Time frame: From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS

  4. 1-year and 2-year OS

    Time frame: From day 0 of HCT to 1-year and 2-years

  5. 1-year and 2-year PFS

    Time frame: From day 0 of HCT to 1-year and 2-years

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqui Rick

CONTACT

[email protected]

2152209675

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Nov 10, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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