RecruitingObservational

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

NCT ID: NCT06610396Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Last updated: 2025-02-26

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.

Outcome measures

Primary

Change in Adipose Tissue (InBody, kg)
Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis
Time frame: 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.
Time frame: 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
Time frame: Baseline and study completion, up to 6 months.

Secondary

Intervention Compliance Rate during Exercise Program (Adherence)
Time frame: Through study completion, up to 6 months.
Feasibility of the Exercise Program
Time frame: Through study completion, up to 6 months.
Adverse Events (Safety)
Time frame: Through study completion, up to 6 months.
Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment
Time frame: Baseline and study completion, up to 6 months.
Changes in Functional Mobility Score at baseline and post-exercise assessment
Time frame: Baseline and study completion, up to 6 months.
Changes in Y-Balance Test Scores at baseline and post-exercise assessment
Time frame: Baseline and study completion, up to 6 months.
Changes in EuroQol-5 Dimensions (EQ-5D) at baseline and post-exercise assessment
Time frame: 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
Time frame: Baseline and study completion, up to 6 months.
Changes in General Anxiety Disorder-7 (GAD7) anxiety score at baseline and post-exercise assessment
Time frame: Baseline and study completion, up to 6 months.
Changes in grip strength at baseline, throughout, and post- exercise assessment
Time frame: Through study completion, up to 6 months.
Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment
Time frame: Through study completion, up to 6 months.
Changes in resting metabolic rate at baseline and post-exercise assessment
Time frame: Through study completion, up to 6 months.

Eligibility criteria

Sex: AllAge: 20 Years to 89 YearsHealthy volunteers: No

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 locations (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Recruiting

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412-330-6151 clinicaltrials@ahn.org