NCT03609203已完成不适用
Improving Self-Efficacy and Resolving Inflammaging in Allogeneic Hematopoietic Cell Transplant Survivors Through Personalized Strength Programming: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Self-reported outcomes of self-efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Self-reported outcomes of self-efficacy
时间窗: Week 10
To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls.
次要结局
- Biomarkers of inflammaging in the blood(Week 10)
研究者
研究点 (1)
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