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
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Clinical Trials Contact
- Phone Number: 412-330-6151
- Email: ctgov@ahn.org
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Adipose Tissue (InBody, kg)
Time Frame: Baseline and study completion, up to 6 months.
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Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis
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Baseline and study completion, up to 6 months.
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Change in Adipose Tissue (Ultrasound, Lbs)
Time Frame: Baseline and study completion, up to 6 months.
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Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound.
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Baseline and study completion, up to 6 months.
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Change in Muscle Mass
Time Frame: Baseline and study completion, up to 6 months.
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Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) and percent fat-free mass (measured by ultrasound) from baseline to six months
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Baseline and study completion, up to 6 months.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Compliance Rate during Exercise Program (Adherence)
Time Frame: Through study completion, up to 6 months.
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Percentage of exercise sessions attended by each participant
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Through study completion, up to 6 months.
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Feasibility of the Exercise Program
Time Frame: Through study completion, up to 6 months.
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Tracking of participant completion status.
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Through study completion, up to 6 months.
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Adverse Events (Safety)
Time Frame: Through study completion, up to 6 months.
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Through study completion, up to 6 months.
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Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment
Time Frame: Baseline and study completion, up to 6 months.
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An individual stands from a chair, walks ten feet and back, and then sits down.
This is timed and recorded in seconds.
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Baseline and study completion, up to 6 months.
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Changes in Functional Mobility Score at baseline and post-exercise assessment
Time Frame: Baseline and study completion, up to 6 months.
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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.
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Baseline and study completion, up to 6 months.
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Changes in Y-Balance Test Scores at baseline and post-exercise assessment
Time Frame: Baseline and study completion, up to 6 months.
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Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.
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Baseline and study completion, up to 6 months.
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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.
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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.
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Baseline assessment (prior to program) and at exercise program completion.
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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.
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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.
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Baseline and study completion, up to 6 months.
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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.
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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.
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Baseline and study completion, up to 6 months.
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Changes in grip strength at baseline, throughout, and post- exercise assessment
Time Frame: Through study completion, up to 6 months.
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Assessed via a Jamar Hand Dynamometer Grip Strength Measurement Meter bilaterally at the neutral position and with the arm over the head
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Through study completion, up to 6 months.
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Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment
Time Frame: Through study completion, up to 6 months.
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Maximum weight lifted during sled training
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Through study completion, up to 6 months.
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Changes in resting metabolic rate at baseline and post-exercise assessment
Time Frame: Through study completion, up to 6 months.
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Through study completion, up to 6 months.
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Colin Champ, MD, AHN Radiation Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2024-115-SG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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