Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-29
Brief Title:
Effectiveness of an Aerobic Exercise Program in Cancer Survivors
Sponsor:
Holy Name Medical Center Inc
Organization:
Holy Name Medical Center Inc
Study Overview
Official Title:
Effectiveness of a Structured Aerobic Exercise Program in Cancer Survivors - A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESAP-CS
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 EndpointsOutcomes
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
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 EndpointsOutcomes
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None