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

March 31, 2022 updated by: Masonic Cancer Center, University of Minnesota

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Masonic Cancer Center, University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shernan G Holtan, MD, Division of Hematology, Oncology and Transplantation, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allogeneic HCT Survivors

Clinical Trials on 10 Weeks of Strength Trailing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings