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OpenTrials
Completed

NCT Number: NCT03609203

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 Weeks of Strength Trailing

Other

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

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

Other

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

Primary outcomes

  1. Self-reported outcomes of self-efficacy

    Time frame: 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 outcomes

  1. Biomarkers of inflammaging in the blood

    Time frame: Week 10

    To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2018
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.