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NCT Number: NCT06610396

Ex Onc SLED: A 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Adipose Tissue (InBody, kg)

    Time frame: Baseline and study completion, up to 6 months.

    Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis

  2. Change in Adipose Tissue (Ultrasound, Lbs)

    Time frame: Baseline and study completion, up to 6 months.

    Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound.

  3. Change in Muscle Mass

    Time frame: Baseline and study completion, up to 6 months.

    Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) and percent fat-free mass (measured by ultrasound) from baseline to six months

Secondary outcomes

  1. Intervention Compliance Rate during Exercise Program (Adherence)

    Time frame: Through study completion, up to 6 months.

    Percentage of exercise sessions attended by each participant

  2. Feasibility of the Exercise Program

    Time frame: Through study completion, up to 6 months.

    Tracking of participant completion status.

  3. Adverse Events (Safety)

    Time frame: Through study completion, up to 6 months.

  4. Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment

    Time frame: Baseline and study completion, up to 6 months.

    An individual stands from a chair, walks ten feet and back, and then sits down. This is timed and recorded in seconds.

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

    Time frame: Baseline and study completion, up to 6 months.

    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.

  6. Changes in Y-Balance Test Scores at baseline and post-exercise assessment

    Time frame: Baseline and study completion, up to 6 months.

    Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.

  7. 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.

    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.

  8. 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.

    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.

  9. 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.

    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.

  10. Changes in grip strength at baseline, throughout, and post- exercise assessment

    Time frame: Through study completion, up to 6 months.

    Assessed via a Jamar Hand Dynamometer Grip Strength Measurement Meter bilaterally at the neutral position and with the arm over the head

  11. Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment

    Time frame: Through study completion, up to 6 months.

    Maximum weight lifted during sled training

  12. Changes in resting metabolic rate at baseline and post-exercise assessment

    Time frame: Through study completion, up to 6 months.

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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