Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients
|
Other: 10 Weeks of Strength Trailing
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
Other: Group Nutrition Discussion: week 1, week 5 and week 10
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
|
| Controls
|
Other: 10 Weeks of Strength Trailing
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
Other: Group Nutrition Discussion: week 1, week 5 and week 10
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
|
Outcome Measures
Primary Outcome Measures
- Self-reported outcomes of self-efficacy [Week 10]
To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls.
Secondary Outcome Measures
- Biomarkers of inflammaging in the blood [Week 10]
To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls.
Eligibility Criteria
Criteria
Healthy Volunteers: must be the friends or relatives of the cancer patients enrolled in this study.
Inclusion Criteria:
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HCT recipients
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Age ≥ 18 years
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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
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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
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Karnofsky performance status ≥ 50% (Appendix III)
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Platelet count ≥ 50,000 without transfusions
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Absolute neutrophil count ≥ 1
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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)
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Currently reside within the Minneapolis-St. Paul metro area
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Has an adult (age ≥ 18) friend or relative who is willing to serve as an exercise partner and healthy control for the study
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If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment
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Willing and able to sign voluntary written consent
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Healthy Controls
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Age ≥ 18 years
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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
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Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed
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Use of ≥ 20+ mg prednisone daily
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Current or planned use of investigational drugs during the study period
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Myocardial infarction or stroke within 6 months
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Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html)
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Any medical condition that the consenting medical provider deems would make the participant unsafe to perform a 10-week strength training program
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Are currently pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- Masonic Cancer Center, University of Minnesota
Investigators
- Principal Investigator: Shernan G Holtan, MD, Division of Hematology, Oncology and Transplantation, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018NTLS073
- MT2018-09R