Ex Onc SLED: a Study Utilizing a Weighted Sled for Horizontal Resistance Training

Ex Onc SLED: a Pilot Study Utilizing a Weighted Sled for Horizontal Resistance Training

This protocol seeks to analyze patient adherence and outcomes after monitored exercise sessions utilizing primarily weighted sled pushes and pulls for linearly progressed resistance training of individuals who have been diagnosed with cancer.

Study Overview

• Status: Recruiting
• Conditions: Cancer

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Clinical Trials Contact; Phone Number: 412-330-6151; Email: ctgov@ahn.org

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
      • Contact: Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with cancer on an exercise program at the AHN Exercise Oncology and Resiliency Center

Description

Inclusion Criteria:

1. Age 20-89 years
2. Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment. They should also consent to use adequate contraception during the course of the study.
3. Participants must be determined capable of engaging in resistance training by exercise personnel and/or study PI and must be able to stand.
4. Participants must complete an assessment by EOC staff and be determined safe to engage in the workout regimen by the study exercise personnel. Any individuals not deemed safe to participate in the basic EOC exercise program will be referred to physical therapy or elsewhere

Exclusion Criteria:

1. Severe arthritic, joint, cardiovascular, or musculoskeletal condition that would interfere with exercise program
2. Individuals deemed able to engage in more intense resistance training utilizing compound movements will not be eligible
3. Pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adipose Tissue (InBody, kg)	Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis	Baseline and study completion, up to 6 months.
Change in Adipose Tissue (Ultrasound, Lbs)	Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound.	Baseline and study completion, up to 6 months.
Change in Muscle Mass	Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) and percent fat-free mass (measured by ultrasound) from baseline to six months	Baseline and study completion, up to 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Compliance Rate during Exercise Program (Adherence)	Percentage of exercise sessions attended by each participant	Through study completion, up to 6 months.
Feasibility of the Exercise Program	Tracking of participant completion status.	Through study completion, up to 6 months.
Adverse Events (Safety)		Through study completion, up to 6 months.
Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment	An individual stands from a chair, walks ten feet and back, and then sits down. This is timed and recorded in seconds.	Baseline and study completion, up to 6 months.
Changes in Functional Mobility Score at baseline and post-exercise assessment	During the test, 7 movement patterns are assessed and each one is rated between 0 and 3 by an examiner. These movements include the deep squat, hurdle step, inline lunge, shoulder mobility test, active straight leg raise, trunk stability push up, and rotary stability test. A score of zero is given if any pain is felt during the movement, 1 if the subject is unable to perform the movement, 2 if the subject performs the movement through compensatory movements, and 3 if the movement is performed correctly. Each movement score is summed and a final score out of 21 is calculated. A score below 14 is felt to identify individuals at risk of injury.	Baseline and study completion, up to 6 months.
Changes in Y-Balance Test Scores at baseline and post-exercise assessment	Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.	Baseline and study completion, up to 6 months.
Changes in EuroQol-5 Dimensions (EQ-5D) at baseline and post-exercise assessment	EuroQol-5 Dimensions-5 Levels total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). This is calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of "no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"/"unable to", respectively. Higher scores mean worse outcomes.	Baseline assessment (prior to program) and at exercise program completion.
Changes in Patient Health Questionnaire-9 (PHQ9) depression score at baseline and post-exercise assessment	Patient Health Questionnaire-9 total score for the 9 questions ranges from 0 (no depression) to 27 (highest level of depression). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.	Baseline and study completion, up to 6 months.
Changes in General Anxiety Disorder-7 (GAD7) anxiety score at baseline and post-exercise assessment	General Anxiety Disorder-7 total score for the seven questions ranges from 0 (no anxiety) to 21 (highest level of anxiety). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of "not at all", "several days", "more than half the days", and "nearly every day", respectively. Higher scores mean a worse outcome.	Baseline and study completion, up to 6 months.
Changes in grip strength at baseline, throughout, and post- exercise assessment	Assessed via a Jamar Hand Dynamometer Grip Strength Measurement Meter bilaterally at the neutral position and with the arm over the head	Through study completion, up to 6 months.
Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment	Maximum weight lifted during sled training	Through study completion, up to 6 months.
Changes in resting metabolic rate at baseline and post-exercise assessment		Through study completion, up to 6 months.

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Investigators: Principal Investigator: Colin Champ, MD, AHN Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): September 18, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: exercise; resistance training
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 2024-115-SG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No