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

University of Minnesota (UMN)

Status: Completed

Conditions: Allogeneic HCT Survivors

Treatments: Other: Group Nutrition Discussion: week 1, week 5 and week 10; Other: 10 Weeks of Strength Trailing

Study type: Observational

Funder types: Other

Identifiers

NCT03609203

2018NTLS073

MT2018-09R (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

25 participants in 2 patient groups

Patients

Treatment:

Other: 10 Weeks of Strength Trailing

Other: Group Nutrition Discussion: week 1, week 5 and week 10

Controls

Treatment:

Other: 10 Weeks of Strength Trailing

Other: Group Nutrition Discussion: week 1, week 5 and week 10