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



Status:Recruiting
Healthy:No
Age Range:21 - Any
Updated:9/15/2018
Start Date:September 10, 2018
End Date:January 1, 2025
Contact:Timothy Krepski, RN
Email:tkrepsk1@fairview.org
Phone:612-273-2800

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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.


Inclusion Criteria:

- HCT recipients

- Age ≥ 21 years

- Between 18 and 36 months post-allogeneic HCT at the time of enrollment

- In remission from hematologic malignancy, not currently receiving maintenance
chemotherapy, immunotherapy, or targeted therapy

- 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 ≥ 1.0

- Pre-transplant left ventricular ejection fraction ≥ 50%

- Identified as pre-frail or frail (e.g., meeting at least 2 of the following 5
criteria), as previously reported10:

- (1) Clinically underweight. This criterion is met based upon BMI ≤ 18.5 or
answering "Yes" to the following question: "In the last year, have you lost more
than 10 pounds unintentionally (i.e., not due to dieting or exercise)?"

- (2) Exhaustion. Using the CES-D Depression Scale (available at
https://tinyurl.com/y9ekgsft), the following two statements are read. (a) I felt
that everything I did was an effort; (b) I could not get going. The question is
asked "How often in the last week did you feel this way?" 0 = rarely or none of
the time (<1 day), 1 = some or a little of the time (1-2 days), 2 = a moderate
amount of the time (3-4 days), or 3 = most of the time. Subjects answering "2" or
"3" to either of these questions are categorized as frail by the exhaustion
criterion.

- (3) Low energy expenditure. Men: Those with Kcals of physical activity per week
≤383 are frail. Women: Those with Kcals per week ≤270 are frail. We will estimate
Kcals of activity per week using the IPAQ elderly short form, available at
https://tinyurl.com/y9amqq24.

- (4) Slowness. This is based upon a 15-foot walk.

- (5) Weakness. This is based upon measurements from a hand dynamometer.

- 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)

- Has an adult (age ≥ 21) friend or relative who is willing to serve as an exercise
partner and healthy control for the study

- Willing and able to sign voluntary written consent

- Healthy Controls

- Age ≥ 21 years

- Karnofsky performance status ≥ 50%

- Body Mass Index ≥ 18 and ≤ 40

- No history of autoimmune or inflammatory disease

- 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)

- 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

- Current use of insulin or other oral hypoglycemic agents

- Peripheral neuropathy grade 2 or greater

- History of osteoporotic fracture

- Current tobacco or marijuana use

- Myocardial infarction or stroke within 6 months

- Any medical condition that the consenting medical provider deems would make the
participant unsafe to perform a 10-week strength training program

- Pre-existing known hypercholesterolemia, hypertriglyceridemia, or mixed hyperlipidemia
requiring medical treatment

• Current use of lipid lowering agents including HMG-CoA reductase inhibitors, vitamin
B3, bile-acid sequestrants, fibrates, 2-azetidiones, omega-3-acids, MTP-inhibitors, or
combination therapy

- Are currently pregnant or may become pregnant

- BMI > 40
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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mi
from
Minneapolis, MN
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