Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors

NCT ID: NCT05558384

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2024-10-01

Brief 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.

Conditions

Cancer; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic exercise

15-week standardized aerobic exercise intervention

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

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)

Interventions

Aerobic Exercise

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Marker

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

22-0356.ccc

Identifier Type: -

Identifier Source: org_study_id