Effectiveness of an Aerobic Exercise Program in Cancer Survivors. (ESAP-CS)

H

Holy Name Medical Center, Inc.

Status

Not yet enrolling

Conditions

Aerobic Exercise

Treatments

Other: Aerobic Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT06254989
24-01-HN

Details and patient eligibility

About

A prospective study of cancer survivor patients enrolling in a pilot aerobic exercise program. The total enrollment will be fifteen patients. The study timeline includes a screening period of 4 weeks, baseline period of 2 weeks, and active study intervention for 12 weeks. Study enrollment will continue until all 15 subjects are enrolled or up to 12 months, whichever comes first.

Full description

Study Population: Adult cancer survivors within one year of completing cancer-directed therapy. Study Objective: To determine the feasibility of a prescription exercise program in a cancer survivor population Specific Objectives: Quantify the number of patients who successfully enroll and complete the Program. Determine a preliminary benefit, if any, of the program with regard to biometric parameters (change in systolic blood pressure, BMI, body composition, average step count, VO2 max), laboratory parameters (Hgb A1c, CRP, Lipid Profile, IL-6, Apolipoprotein B, Vitamin D-25-OH, Vitamin B12 and Folate), patient-reported wellness surveys (SEE, SRQ, Sleep Surveys). Study Endpoints/Outcomes: A. Percentage of participants who complete the Program. B. Change in systolic blood pressure C. Change in BMI D. Change in body composition E. Change in Average daily step count F. Change in predicted VO2 max F. Change in participant-reported wellness surveys (SEE, SRQ, and Sleep Surveys) G. Change in Circumference measurements (hip, waist, and neck) H. Improvement in laboratory parameters (Hgb A1c, CRP, Lipid profile, IL-6, Alipoprotein B, Vitamin D-25-OH, Vitamin B12, Folate) I. Cancer recurrence Sample Size: Fifteen subjects

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult (>18 yr.) cancer survivor patients who completed treatment within the past year and are able to physically participate in the interventional aerobic exercise program.

Exclusion criteria

  • Non-ambulatory individuals
  • Inability to communicate in English
  • Lack of transportation to/from appointments (Of note, language and transportation exclusion criteria are based on practical needs for this pilot study. If effective, services would be open to a broader array of patients).
  • On medications (e.g., Ozempic, Tirzepatide) which induce prolonged weight loss.
  • Patients who received cancer-directed therapy within the past month.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

Dan Rector, RN; George Miller, MD

Data sourced from clinicaltrials.gov

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