Effectiveness of an Aerobic Exercise Program in Cancer Survivors.

Aerobic Exercise Clinical Trial

— ESAP-CS  

Official title:

Effectiveness of a Structured Aerobic Exercise Program in Cancer Survivors - A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254989
• Other study ID #: 24-01-HN
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Holy Name Medical Center, Inc.
• Contact: George Miller, MD
• Phone: 2015307934
• Email: Gemiller[@]holyname.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aerobic Exercise

Intervention

Other:
• Aerobic 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Holy Name Medical Center, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of providing a structured in-person aerobic exercise intervention	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.	6 months
Secondary	Weight in Lbs	Change in weight (Lbs) from baseline	6 months
Secondary	Blood Pressure in mmHg	Change in blood pressure (mmHg) from baseline	6 months
Secondary	Heart Rate in bpm	Change in Heart rate (bpm) from baseline	6 months
Secondary	Body Mass Index (BMI) in Kg/m2	Change in BMI from baseline. BMI will be calculated as weight (kg)/height (m2).	6 months
Secondary	Predicted VO2 max in ml/kg/min	Change in predicted VO2 max from baseline calculated as the milliliters of Oxygen used per kg of body weight per minute	6 months
Secondary	Percentage lean body mass	Change in lean body mass percentage from baseline	6 months
Secondary	Percentage visceral fat	Change in visceral fat percentage from baseline	6 months
Secondary	Percentage total body fat	Change in total body fat percentage from baseline	6 months
Secondary	Hip circumference measurement in cm	Change in hip circumference measurements from baseline	6 months
Secondary	Waist circumference measurement in cm	Change in waist circumference measurements from baseline	6 months
Secondary	Neck circumference measurements in cm	Change in Neck circumference measurements from baseline	6 months
Secondary	Laboratory Assessments of Nutrition, Glucose control and cardiovascular health	Change in laboratory Assessments of Nutrition, Glucose control and cardiovascular health	6 months
Secondary	Average daily step count	Change in average daily step count from baseline	6 months