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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05865 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| SOL-19103-L | Other Identifier | OHSU Knight Cancer Institute | |
| STUDY00019942 | Other Identifier | OHSU Institutional Review Board | |
| P30CA069533 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
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This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an independent lifestyle. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.
PRIMARY OBJECTIVE:
I. To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors.
SECONDARY OBJECTIVES:
I. To assess secondary measures of feasibility of a home-based, individualized PRT program in sarcoma survivors.
II. To determine if a 3-month PRT program improves physical function in sarcoma survivors.
EXPLORATORY OBJECTIVE:
I. To determine if a 3 month resistance training program improves body composition and bone mineral density.
OUTLINE:
Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.
After completion of study, patients are followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (resistance training, exercise counseling) | Experimental | Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Counseling | Other | Receive instructional guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Number of evaluable participants who completed end-of-intervention assessments | From the time of enrollment up to 3 months end-of-intervention assessments |
| Exercise Adherence | Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions. | From the time of enrollment up to completion of 12 week exercise intervention |
| Frequency of Related Serious Adverse Events (SAEs) | Number of participants that experienced exercise-related SAEs | From the time of enrollment up to completion of 12 week exercise intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Individualized Progressive Resistance Training (PRT) Prescriptions | Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist. | From the time of enrollment up to completion of 12 week exercise intervention |
| Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value |
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Inclusion Criteria:
Eligible for the Sarcoma Survivorship Registry (Institutional Review Board [IRB] #12039)
Sarcoma location must have been in the extremities, body wall, pelvic/shoulder girdle or axial skeleton. Intra-thoracic, intra-abdominal or cranial sarcomas are not eligible
Currently engaging in < 1 hour of resistance exercise per week by self-report. Examples of resistance exercise include: using free weights or weight machines, push-ups, sit-ups, lunges, plank, etc.
Able and willing to commit to attending weekly video coaching sessions and independently completing weekly resistance training sessions. This requires access to internet and a device with video and audio capabilities. A webcam may be provided by the study to the participant if needed
Able and willing to commit to attending one initial in-person training session and one in-person follow-up assessment
Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
Medical contraindication(s) to any and all resistance training as determined by treating physician
Non-English speaking. At this time, we do not have resources to support translation of exercise physiologist (EP) sessions
Dependent on a mobility device (e.g., crutches, wheelchair) for independent activities of daily living (IADLs)
Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results (e.g., pregnancy)
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| Name | Affiliation | Role |
|---|---|---|
| Lara E Davis | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42343234 | Derived | Davis LE, Austin SC, Hayden JB, Doung YC, Gundle KR, Ryan CW, Stoyles SA, Winters-Stone KM. Remotely delivered resistance training program in adult sarcoma survivors: a pilot study. BMC Cancer. 2026 Jun 25. doi: 10.1186/s12885-026-16399-z. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care (Resistance Training, Exercise Counseling) | Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care (Resistance Training, Exercise Counseling) | Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention | Number of evaluable participants who completed end-of-intervention assessments | Posted | Count of Participants | Participants | From the time of enrollment up to 3 months end-of-intervention assessments |
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Adverse event data were collected from the time of consent until the end of treatment visit (12 weeks). Any clinically significant adverse events persisting at the end of treatment visit were followed until resolution, stabilization, or death, whichever came first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supportive Care (Resistance Training, Exercise Counseling) | Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks |
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The COVID pandemic resulted in extensive protocol revisions to pivot from in person assessments to telehealth. Multiple secondary endpoints were therefore not collected
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lara Davis, MD | Oregon Health & Science University | 5034948423 | davisla@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 16, 2020 | Apr 26, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Resistance Training | Other | Complete progressive resistance training |
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The PROMIS-Cancer assessment consists of 45 questions pertaining to physical function, each of which are designed as having five-point ordinal rating scales. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents "unable to do" and 5 represents "without any difficulty." Each PROMIS assessment generates a T-score, which is a standardized score with a mean of 50 and standard deviation of 10 in a reference population of cancer patients, i.e., a score of 40 is one SD lower than the mean of the reference population. A PROMIS-Cancer Physical Function score less than 50 indicates patient-reported physical function worse than the cancer patient mean. The PROMIS T-scores are summarized with mean and standard deviation, with comparison of scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. |
| Baseline up to completion of 12 week exercise intervention |
| Change in Short Form-36 Physical Function Score | The 36-Item Short Form Health Survey (SF-36) consists of a set of generic, quality-of-life measures to survey physical function in the general population. Responses range from 0 - 100, with a higher score indicating a more favorable health state. Will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Baseline up to completion of 12 week exercise intervention |
| Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) | To score the GLTEQ, the weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components as shown in the following formula: Weekly leisure activity score = (9xStrenuous) + (5x Moderate) + (3xLight). Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score). GLTEQ will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Baseline up to completion of 12 week exercise intervention |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) | Fatigue was assessed using the FACT-F scale. This is a 13 item, uni-dimensional, 5-point Likert scale, measuring physical fatigue over the past week. The scale has high internal consistency and is widely used in the literature. Responses range from 0 - 52, with a higher score indicating more fatigue. FACT-F will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Baseline up to completion of 12 week exercise intervention |
| Difference in 1-repetition Maximum (Kilogram) | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated. | Baseline up to completion of 12 week exercise intervention |
| Change in Short Physical Performance Battery Score | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Baseline up to completion of 12 week exercise intervention |
| Change in Grip Strength (Kilogram) | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Baseline up to completion of 12 week exercise intervention |
| Change in Gait and Balance | Measured by mobile sensor. Will compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Baseline up to completion of 12 week exercise intervention |
| Change in Instrumented 6-minute Walk Test | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Baseline up to completion of 12 week exercise intervention |
| Change in Instrumented Postural Sway | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Baseline up to completion of 12 week exercise intervention |
| Change in Instrumented Timed up and go Test | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Baseline up to completion of 12 week exercise intervention |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Exercise Adherence | Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions. | Posted | Count of Participants | Participants | From the time of enrollment up to completion of 12 week exercise intervention |
|
|
|
| Primary | Frequency of Related Serious Adverse Events (SAEs) | Number of participants that experienced exercise-related SAEs | Posted | Count of Participants | Participants | From the time of enrollment up to completion of 12 week exercise intervention |
|
|
|
| Secondary | Individualized Progressive Resistance Training (PRT) Prescriptions | Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist. | Posted | Count of Participants | Participants | From the time of enrollment up to completion of 12 week exercise intervention |
|
|
|
| Secondary | Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value | The PROMIS-Cancer assessment consists of 45 questions pertaining to physical function, each of which are designed as having five-point ordinal rating scales. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents "unable to do" and 5 represents "without any difficulty." Each PROMIS assessment generates a T-score, which is a standardized score with a mean of 50 and standard deviation of 10 in a reference population of cancer patients, i.e., a score of 40 is one SD lower than the mean of the reference population. A PROMIS-Cancer Physical Function score less than 50 indicates patient-reported physical function worse than the cancer patient mean. The PROMIS T-scores are summarized with mean and standard deviation, with comparison of scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to completion of 12 week exercise intervention |
|
|
|
|
| Secondary | Change in Short Form-36 Physical Function Score | The 36-Item Short Form Health Survey (SF-36) consists of a set of generic, quality-of-life measures to survey physical function in the general population. Responses range from 0 - 100, with a higher score indicating a more favorable health state. Will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to completion of 12 week exercise intervention |
|
|
|
|
| Secondary | Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) | To score the GLTEQ, the weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components as shown in the following formula: Weekly leisure activity score = (9xStrenuous) + (5x Moderate) + (3xLight). Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score). GLTEQ will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Posted | Mean | Standard Deviation | arbitrary units | Baseline up to completion of 12 week exercise intervention |
|
|
|
|
| Secondary | Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) | Fatigue was assessed using the FACT-F scale. This is a 13 item, uni-dimensional, 5-point Likert scale, measuring physical fatigue over the past week. The scale has high internal consistency and is widely used in the literature. Responses range from 0 - 52, with a higher score indicating more fatigue. FACT-F will be summarized as mean and standard deviation. Will also compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to completion of 12 week exercise intervention |
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|
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| Secondary | Difference in 1-repetition Maximum (Kilogram) | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated. | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
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| Secondary | Change in Short Physical Performance Battery Score | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
|
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| Secondary | Change in Grip Strength (Kilogram) | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
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| Secondary | Change in Gait and Balance | Measured by mobile sensor. Will compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
|
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| Secondary | Change in Instrumented 6-minute Walk Test | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
|
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| Secondary | Change in Instrumented Postural Sway | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
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| Secondary | Change in Instrumented Timed up and go Test | Compare scores at baseline and at 3 months using paired t-Test to determine if a 3-month resistance training program improves physical function. Will initially examine distribution of each outcome variable using Shapiro-Wilk test, as well as data visualization techniques as standard practice. Will consider transforming the data or adopting non-parametric approaches if normality assumption is violated | Data could not be collected due to COVID restrictions | Posted | Baseline up to completion of 12 week exercise intervention |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |