An interventional study of Aerobic Exercise in Aerobic Exercise, sponsored by Holy Name Medical Center, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Holy Name Medical Center, Inc. · Not applicable, Interventional, and Other
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.
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:
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
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Holy Name Medical Center, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Compared within Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 6 months
Weight in Lbs
Change in weight (Lbs) from baseline
Time frame: 6 months
Blood Pressure in mmHg
Change in blood pressure (mmHg) from baseline
Time frame: 6 months
Heart Rate in bpm
Change in Heart rate (bpm) from baseline
Time frame: 6 months
Body Mass Index (BMI) in Kg/m2
Change in BMI from baseline. BMI will be calculated as weight (kg)/height (m2).
Time frame: 6 months
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
Time frame: 6 months
Percentage lean body mass
Change in lean body mass percentage from baseline
Time frame: 6 months
Percentage visceral fat
Change in visceral fat percentage from baseline
Time frame: 6 months
Percentage total body fat
Change in total body fat percentage from baseline
Time frame: 6 months
Hip circumference measurement in cm
Change in hip circumference measurements from baseline
Time frame: 6 months
Waist circumference measurement in cm
Change in waist circumference measurements from baseline
Time frame: 6 months
Neck circumference measurements in cm
Change in Neck circumference measurements from baseline
Time frame: 6 months
Laboratory Assessments of Nutrition, Glucose control and cardiovascular health
Change in laboratory Assessments of Nutrition, Glucose control and cardiovascular health
Time frame: 6 months
Average daily step count
Change in average daily step count from baseline
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Holy Name Medical Center, Inc.