Aerobic Exercise
Conditions
Keywords
Exercise, Cancer, Survivorship
Brief summary
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.
Detailed 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: 1. Quantify the number of patients who successfully enroll and complete the Program. 2. 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
Interventions
OTHERAerobic Exercise
Participants will engage in aerobic exercise at HNH fitness at a minimum of 2 days a week for 12 weeks. Participants will have their daily step count collected via the Fitbit during this period. VO2 measurements will also be collected during active intervention using the UNCCRI protocol. The structured aerobic exercise program (Weeks 3-14) will entail 30 minutes of aerobic activity, 3 days a week, on the treadmill, at a goal of between 50 to 70% of predicted VO2 maximum heart rate. All structured aerobic program sessions will take place at Holy Name Health (HNH) Fitness and will be overseen by our collaborator and Director of Human Performance (Reg Grant). Exercise data will be recorded in the Technogym MyWellness cloud. Participants who drop out or discontinue attendance (defined as 4 consecutive sessions missed without notification of absence) before completion of the 12-week study intervention period will be replaced.
Sponsors
Holy Name Medical Center, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of providing a structured in-person aerobic exercise intervention | 6 months | To determine the feasibility of providing a structured in-person aerobic exercise training intervention to cancer survivor patients by determining the percentage of enrolled patients who complete the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate in bpm | 6 months | Change in Heart rate (bpm) from baseline |
| Weight in Lbs | 6 months | Change in weight (Lbs) from baseline |
| Body Mass Index (BMI) in Kg/m2 | 6 months | Change in BMI from baseline. BMI will be calculated as weight (kg)/height (m2). |
| Predicted VO2 max in ml/kg/min | 6 months | Change in predicted VO2 max from baseline calculated as the milliliters of Oxygen used per kg of body weight per minute |
| Percentage lean body mass | 6 months | Change in lean body mass percentage from baseline |
| Percentage visceral fat | 6 months | Change in visceral fat percentage from baseline |
| Blood Pressure in mmHg | 6 months | Change in blood pressure (mmHg) from baseline |
| Hip circumference measurement in cm | 6 months | Change in hip circumference measurements from baseline |
| Waist circumference measurement in cm | 6 months | Change in waist circumference measurements from baseline |
| Neck circumference measurements in cm | 6 months | Change in Neck circumference measurements from baseline |
| Laboratory Assessments of Nutrition, Glucose control and cardiovascular health | 6 months | Change in laboratory Assessments of Nutrition, Glucose control and cardiovascular health |
| Average daily step count | 6 months | Change in average daily step count from baseline |
| Percentage total body fat | 6 months | Change in total body fat percentage from baseline |
Contacts
Primary ContactGeorge Miller, MD
Backup ContactDan Rector, RN
Outcome results
None listed