CancerNCT06610396
Ex Onc SLED: A Study Utilizing A Weighted Sled for Horizontal Resistance Training
An observational study of Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 16 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed with cancer on an exercise program at the AHN Exercise Oncology and Resiliency Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Ex Onc SLED: A Pilot 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.
- Conditions
- Cancer
- Keywords
- exercise, resistance training
- Medical subject headings
- Neoplasms, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adipose Tissue (InBody, kg)
Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis
Measured: 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.
Measured: 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
Measured: Baseline and study completion, up to 6 months.
Secondary outcomes (12)
Intervention Compliance Rate during Exercise Program (Adherence)
Percentage of exercise sessions attended by each participant
Measured: Through study completion, up to 6 months.
Feasibility of the Exercise Program
Tracking of participant completion status.
Measured: Through study completion, up to 6 months.
Adverse Events (Safety)
Measured: Through study completion, up to 6 months.
Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment
An individual stands from a chair, walks ten feet and back, and then sits down. This is timed and recorded in seconds.
Measured: Baseline and study completion, up to 6 months.
Changes in Functional Mobility Score at baseline and post-exercise assessment
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.
Measured: Baseline and study completion, up to 6 months.
Changes in Y-Balance Test Scores at baseline and post-exercise assessment
Reach distances in three directions (anterior, posteromedial, and posterolateral) measured in centimeters.
Measured: Baseline and study completion, up to 6 months.
Changes in EuroQol-5 Dimensions (EQ-5D) at baseline and post-exercise assessment
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.
Measured: 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
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.
Measured: Baseline and study completion, up to 6 months.
Changes in General Anxiety Disorder-7 (GAD7) anxiety score at baseline and post-exercise assessment
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.
Measured: Baseline and study completion, up to 6 months.
Changes in grip strength at baseline, throughout, and post- exercise assessment
Assessed via a Jamar Hand Dynamometer Grip Strength Measurement Meter bilaterally at the neutral position and with the arm over the head
Measured: Through study completion, up to 6 months.
Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment
Maximum weight lifted during sled training
Measured: Through study completion, up to 6 months.
Changes in resting metabolic rate at baseline and post-exercise assessment
Measured: Through study completion, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start18 Jun 2024
- Primary completion18 Dec 2026 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Colin Champ, MD, Principal investigator, AHN Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610396
- Sponsor's protocol ID
- 2024-115-SG
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Onc SLED: A Pilot Study Utilizing A Weighted Sled for Horizontal Resistance Training
- ClinicalTrials.gov ID
- NCT06610396
- Acronym / sponsor ID
- 2024-115-SG
- Conditions
- Cancer
- Keywords
- exercise, resistance training
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with cancer on an exercise program at the AHN Exercise Oncology and Resiliency Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Champ, MD principal investigator
AHN Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adipose Tissue (InBody, kg) (time frame: Baseline and study completion, up to 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.