Effectiveness of a Cancer Exercise Program

Sponsor

University of South Carolina (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06039488

Collaborator

(none)

150

Enrollment

Location

Arm

64.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 15, 2021

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Bellarmine Norton Assessment Tool (2-minute Step Test) [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
Bellarmine Norton Assessment Tool (Timed Arm Curl) [0 and 8-weeks]
Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds)
Bellarmine Norton Assessment Tool (30 second Chair Stand) [0 and 8-weeks]
Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds

Secondary Outcome Measures

Fatigue [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Carolina	Columbia	South Carolina	United States	29205

Sponsors and Collaborators

University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ciaran Fairman, Assistant Professor, University of South Carolina

ClinicalTrials.gov Identifier:

NCT06039488

Other Study ID Numbers:

Pro00109975

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ciaran Fairman, Assistant Professor, University of South Carolina

Exercise

Study Results

No Results Posted as of Sep 15, 2023