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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06039488
Other study ID # Pro00109975
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 15, 2021
Est. completion date January 2027

Study information

Verified date September 2023
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date January 2027
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bellarmine Norton Assessment Tool (2-minute Step Test) 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
Primary Bellarmine Norton Assessment Tool (Timed Arm Curl) Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds) 0 and 8-weeks
Primary Bellarmine Norton Assessment Tool (30 second Chair Stand) Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds 0 and 8-weeks
Secondary Fatigue 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
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