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

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

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.

Study Overview

• Status: Completed
• Conditions: Allogeneic HCT Survivors
• Intervention / Treatment: Other: 10 Weeks of Strength Trailing; Other: Group Nutrition Discussion: week 1, week 5 and week 10

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A maximum of four pairs of patient/workout partners (8 subjects) should be actively participating in the 10-week group intervention on study at a time. Participants may sign consent at anytime but then begin group participation when spots become available.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Shernan G Holtan, MD, Division of Hematology, Oncology and Transplantation, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2018NTLS073; MT2018-09R (Other Identifier: University of Minnesota Masonic Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No