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

NCT ID: NCT03609203

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2021-03-31

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.

Conditions

Allogeneic HCT Survivors

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

10 Weeks of Strength Trailing

Intervention Type: 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

Intervention Type: 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

Controls

10 Weeks of Strength Trailing

Intervention Type: 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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shernan G Holtan, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Hematology, Oncology and Transplantation, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MT2018-09R

Identifier Type: OTHER

Identifier Source: secondary_id

2018NTLS073

Identifier Type: -

Identifier Source: org_study_id