Effectiveness of an Aerobic Exercise Program in Cancer Survivors.

NCT06254989 | Not Yet Recruiting

• 1 other identifier: 24-01-HN
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aerobic Exercise

Keywords

Exercise; Cancer; Survivorship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Weight in Lbs

  6 months

• Blood Pressure in mmHg

  6 months

• Heart Rate in bpm

  6 months

• Body Mass Index (BMI) in Kg/m2

  6 months

• Predicted VO2 max in ml/kg/min

  6 months

Interventions

Aerobic Exercise OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-ambulatory individuals
• Inability to communicate in English
• On medications (e.g., Ozempic, Tirzepatide) which induce prolonged weight loss.
• Patients who received cancer-directed therapy within the past month.

Sponsors & Collaborators

• Holy Name Medical Center, Inc.: lead

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• George Miller, MD

  Holy Name Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Miller, MD

CONTACT

2015307934; Gemiller@holyname.org

Dan Rector, RN

CONTACT

2018334742; drector@holyname.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Surgical Oncology

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 12, 2024
• Study Start: February 12, 2024
• Primary Completion: February 28, 2025
• Study Completion: June 30, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-02