Clinical trial NCT06610396: Ex Onc SLED: a Study Utilizing a Weighted Sled for Horizontal Resistance Training
Official title: Ex Onc SLED: a Pilot Study Utilizing a Weighted Sled for Horizontal Resistance Training
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: exercise
resistance training
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with cancer on an exercise program at the AHN Exercise Oncology and Resiliency Center

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Adipose Tissue (InBody, kg)
timeFrame: Baseline and study completion, up to 6 months.
measure: Change in Adipose Tissue (Ultrasound, Lbs)
timeFrame: Baseline and study completion, up to 6 months.
measure: Change in Muscle Mass
timeFrame: Baseline and study completion, up to 6 months.
Secondary outcomes:
measure: Intervention Compliance Rate during Exercise Program (Adherence)
timeFrame: Through study completion, up to 6 months.
measure: Feasibility of the Exercise Program
timeFrame: Through study completion, up to 6 months.
measure: Adverse Events (Safety)
timeFrame: Through study completion, up to 6 months.
measure: Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment
timeFrame: Baseline and study completion, up to 6 months.
measure: Changes in Functional Mobility Score at baseline and post-exercise assessment
timeFrame: Baseline and study completion, up to 6 months.
measure: Changes in Y-Balance Test Scores at baseline and post-exercise assessment
timeFrame: Baseline and study completion, up to 6 months.
measure: Changes in EuroQol-5 Dimensions (EQ-5D) at baseline and post-exercise assessment
timeFrame: Baseline assessment (prior to program) and at exercise program completion.
measure: Changes in Patient Health Questionnaire-9 (PHQ9) depression score at baseline and post-exercise assessment
timeFrame: Baseline and study completion, up to 6 months.
measure: Changes in General Anxiety Disorder-7 (GAD7) anxiety score at baseline and post-exercise assessment
timeFrame: Baseline and study completion, up to 6 months.
measure: Changes in grip strength at baseline, throughout, and post- exercise assessment
timeFrame: Through study completion, up to 6 months.
measure: Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment
timeFrame: Through study completion, up to 6 months.
measure: Changes in resting metabolic rate at baseline and post-exercise assessment
timeFrame: Through study completion, up to 6 months.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: AHN Radiation Oncology
name: Colin Champ, MD
role: PRINCIPAL_INVESTIGATOR
References: