Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training

Study Overview
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Brief Summary
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This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.

Official Title
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Improving Self-Efficacy and Resolving Inflammaging in Allogeneic Hematopoietic Cell Transplant Survivors Through Personalized Strength Programming: A Pilot Study

Conditions
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Allogeneic HCT Survivors

Intervention / Treatment
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* Other: 10 Weeks of Strength Trailing
* Other: Group Nutrition Discussion: week 1, week 5 and week 10


Participation Criteria
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Eligibility Criteria
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Healthy Volunteers: must be the friends or relatives of the cancer patients enrolled in this study. Inclusion Criteria: HCT recipients Age ≥ 18 years Greater than 6 months after completing systemic multiagent chemotherapy (greater than 12 months for HCT participants) at the time of enrollment. Maintenance chemotherapy is allowed In remission from cancer Off immunosuppression, or on a stable immunosuppression regimen with prednisone doses ≤ 20 mg daily, with no changes planned to the immunosuppression regimen during the study period Karnofsky performance status ≥ 50% (Appendix III) Platelet count ≥ 50,000 without transfusions Absolute neutrophil count ≥ 1 Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw) Currently reside within the Minneapolis-St. Paul metro area Has an adult (age ≥ 18) friend or relative who is willing to serve as an exercise partner and healthy control for the study If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment Willing and able to sign voluntary written consent Healthy Controls Age ≥ 18 years Karnofsky performance status ≥ 50% Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw) Currently reside within the Minneapolis-St. Paul metro area If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment Willing and able to sign voluntary written consent Exclusion Criteria for both Cancer Survivors and Controls Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed Use of ≥ 20+ mg prednisone daily Current or planned use of investigational drugs during the study period Myocardial infarction or stroke within 6 months Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html) Any medical condition that the consenting medical provider deems would make the participant unsafe to perform a 10-week strength training program Are currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br> | Other: 10 Weeks of Strength Trailing<br>* Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples<br>Other: Group Nutrition Discussion: week 1, week 5 and week 10<br>* Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples<br>|
| Controls<br> | Other: 10 Weeks of Strength Trailing<br>* Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples<br>Other: Group Nutrition Discussion: week 1, week 5 and week 10<br>* Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported outcomes of self-efficacy | To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls. | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of inflammaging in the blood | To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls. | Week 10 |