Improve Outcomes for Older Allogeneic Transplant Recipients

Study Overview
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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.

Official Title
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Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients

Conditions
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Allogeneic Transplantation

Intervention / Treatment
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* Behavioral: Exercise Program (Cohort A Prehab)
* Behavioral: Exercise Program (Cohort B Rehab)


Participation Criteria
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Eligibility Criteria
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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 1. Comorbid disability or illness that prevents safe exercise.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A (Prehab)<br>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)<br>* 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.<br>|
| Experimental: Cohort B (Rehab)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |