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

NCT06610396 | Recruiting DMC

• 1 other identifier: 2024-115-SG
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

exercise; resistance training

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Intervention Compliance Rate during Exercise Program (Adherence)

  Through study completion, up to 6 months.

• Feasibility of the Exercise Program

  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

  Baseline and study completion, up to 6 months.

• Changes in Functional Mobility Score at baseline and post-exercise assessment

  Baseline and study completion, up to 6 months.

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 20-89 years
• 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.
• Participants must be determined capable of engaging in resistance training by exercise personnel and/or study PI and must be able to stand.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Colin Champ, MD

  AHN Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Contact

CONTACT

412-330-6151; ctgov@ahn.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

US (1)