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

Completed

• Conditions: Allogeneic HCT Survivors
• Interventions: Other: 10 Weeks of Strength Trailing

• Registration Number: NCT03609203
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-08-01
• Study Start: 2018-09-10
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	10 Weeks of Strength Trailing	-
Patients	10 Weeks of Strength Trailing	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States