Effectiveness of a Cancer Exercise Program

September 12, 2023 updated by: Ciaran Fairman, University of South Carolina

The Impact of an 8-week Exercise Program on Physical Function in Individuals With Cancer

The investigators are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (>18 years old) with cancer.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29205
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults > 18 diagnosed with cancer

Exclusion Criteria:

  • unwilling to come to the on-site clinic for exercise sessions
  • any neuromuscular, cardiovascular, or psychological condition precluding safe exercise
  • unable to read/understand English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
2 days/week of resistance and cardiovascular exercise for 8-weeks
Behavioral: Exercise

A combination of resistance exercise and cardiovascular exercise (performed 2 days per week for 8-weeks) is tailored to each individual in accordance with their medical/cancer-related history, baseline assessments of physical function, and overall goals.

Resistance exercise includes 6-8 exercises targeting major muscle groups. The first week of the program is used to familiarize participants to the exercises of the program, provide coaching on safe and appropriate technique, and identifying initial load for 2 sets of 12 repetitions (equivalent to ~65% 1 repetition maximum), with a goal of working towards 4 sets of 8 reps. Additionally, participants are asked to perform 20-30 minutes of moderate-to-vigorous aerobic activity (approximately 60-85% age-predicted heart rate maximum) via walking, jogging, or cycling each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bellarmine Norton Assessment Tool (2-minute Step Test)
Time Frame: 0 and 8-weeks
2-minute Step Test: Number of times an individuals' knee reaches a predetermined heigh during a 2-minute period of marching
0 and 8-weeks
Bellarmine Norton Assessment Tool (Timed Arm Curl)
Time Frame: 0 and 8-weeks
Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds)
0 and 8-weeks
Bellarmine Norton Assessment Tool (30 second Chair Stand)
Time Frame: 0 and 8-weeks
Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds
0 and 8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 0 and 8-weeks
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: The FACIT-Fatigue scale is a 13-item scale that will be used to assess cancer-related fatigue. The FACIT-Fatigue scale is scored on a 0-4 response scale from 0 = "not at all" to 4 "very much", regarding items related to fatigue and energy in the past 7 days. Lower score indicates greater fatigue
0 and 8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00109975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe