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Trial Title:
Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors
NCT ID:
NCT05558384
Condition:
Cancer
Overweight and Obesity
Conditions: Official terms:
Overweight
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single-arm feasibility pilot
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Aerobic Exercise
Description:
A 15-week standardized aerobic exercise intervention.
- Frequency: 5 days/wk (2 supervised)
- Intensity: 50-59% heart rate reserve
- Time: 40 min/session (ramp up from 25-40 during first 4 weeks)
- Type: Aerobic exercise (e.g. treadmill, walking/jogging, cycling, elliptical)
Arm group label:
Aerobic exercise
Summary:
This is a pilot feasibility study of an investigation of the influence of excess
adiposity on cardiorespiratory fitness (CRF), insulin-like growth factor-1 (IGF-1), and
metabolic responses to a standardized aerobic exercise program in cancer survivors. This
investigation attempts to isolate the influence of adiposity on these responses. We will
enroll overweight, obese, and normal weight cancer survivors with a primary diagnosis of
breast, prostate, or colorectal cancer who have completed all cancer-related treatment.
Participants will engage in a 15-week aerobic exercise intervention with pre- and
post-intervention assessments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Primary cancer diagnosis of breast, prostate, or colorectal cancer
- Completion of all cancer-related treatment > than 6 months prior and < 5 years prior
to enrollment
- Ability and willingness to participate in a supervised exercise program
- All participants will be required to obtain a signed physician clearance to
participate in exercise form prior to enrollment
Exclusion Criteria:
- Presence of a secondary active cancer diagnosis or metastatic disease
- Any current cancer treatment (including hormonal treatment) or planned cancer
treatment in the next 5 months
- Greater than 100 min of self-reported regular exercise per week
- BMI < 18.5 (underweight)
- Any significant metabolic condition, such as diabetes. Individuals with pre-diabetes
or metabolic syndrome will not be excluded, but this information will be recorded.
- Any medical condition that would impact the safety of, or participation in, an
exercise program or exercise testing, including:
- Orthopedic conditions such as advanced osteoarthritis, mobility-limiting
amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
- Advanced rheumatoid arthritis or chronic widespread pain conditions such as
fibromyalgia
- Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema,
or interstitial lung disease
- Known cardiovascular disease, uncontrolled hypertension, or new cardiac event
within the past 6 months
Gender:
All
Minimum age:
21 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bennie Lindeque, MD
Phone:
303-399-8020
Email:
bennie.lindeque@cuanschutz.edu
Start date:
March 22, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558384
