Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Penn IRB# 851615 | Other Identifier | University of Pennsylvania IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (Prehab) | Experimental | 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. |
|
| Cohort B (Rehab) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Cohort A (Prehab)
Cohort B (Rehab)
Exclusion Criteria:
Cohorts A and B
1. Comorbid disability or illness that prevents safe exercise.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqui Rick | Contact | 2152209675 | Jacqui.Rick@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shannon McCurdy, MD | Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |