- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247425
Progressive Resistance Training for the Improvement of Physical Function
A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Eligible for the Sarcoma Survivorship Registry (Institutional Review Board [IRB] #12039)
- History of histologically-confirmed sarcoma
- History of treatment with surgery, radiation and/or chemotherapy for the sarcoma diagnosis
- Completion of sarcoma treatment >= 2 years prior to study enrollment
- No evidence of recurrent or residual disease on surveillance exam or imaging for at least 2 years prior to study enrollment
- 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)
- Use of a cane is permitted
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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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Ancillary studies
Other Names:
Ancillary studies
Receive instructional guidance
Complete progressive resistance training
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention
Time Frame: From the time of enrollment up to 3 months end-of-intervention assessments
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Number of evaluable participants who completed end-of-intervention assessments
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From the time of enrollment up to 3 months end-of-intervention assessments
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Exercise Adherence
Time Frame: From the time of enrollment up to completion of 12 week exercise intervention
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Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.
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From the time of enrollment up to completion of 12 week exercise intervention
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Frequency of Related Serious Adverse Events (SAEs)
Time Frame: From the time of enrollment up to completion of 12 week exercise intervention
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Number of participants that experienced exercise-related SAEs
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From the time of enrollment up to completion of 12 week exercise intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individualized Progressive Resistance Training (PRT) Prescriptions
Time Frame: From the time of enrollment up to completion of 12 week exercise intervention
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Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.
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From the time of enrollment up to completion of 12 week exercise intervention
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Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value
Time Frame: Baseline up to completion of 12 week exercise intervention
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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.
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Baseline up to completion of 12 week exercise intervention
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Change in Short Form-36 Physical Function Score
Time Frame: Baseline up to completion of 12 week exercise intervention
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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.
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Baseline up to completion of 12 week exercise intervention
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Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)
Time Frame: Baseline up to completion of 12 week exercise intervention
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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.
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Baseline up to completion of 12 week exercise intervention
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Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)
Time Frame: Baseline up to completion of 12 week exercise intervention
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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.
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Baseline up to completion of 12 week exercise intervention
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Difference in 1-repetition Maximum (Kilogram)
Time Frame: Baseline up to completion of 12 week exercise intervention
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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.
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Baseline up to completion of 12 week exercise intervention
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Change in Short Physical Performance Battery Score
Time Frame: Baseline up to completion of 12 week exercise intervention
|
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
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Baseline up to completion of 12 week exercise intervention
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Change in Grip Strength (Kilogram)
Time Frame: Baseline up to completion of 12 week exercise intervention
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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
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Baseline up to completion of 12 week exercise intervention
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Change in Gait and Balance
Time Frame: Baseline up to completion of 12 week exercise intervention
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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
Time Frame: Baseline up to completion of 12 week exercise intervention
|
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
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Change in Instrumented Postural Sway
Time Frame: Baseline up to completion of 12 week exercise intervention
|
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
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Change in Instrumented Timed up and go Test
Time Frame: Baseline up to completion of 12 week exercise intervention
|
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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lara E Davis, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00019942 (Other Identifier: OHSU Institutional Review Board)
- P30CA069533 (U.S. NIH Grant/Contract)
- NCI-2019-05865 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SOL-19103-L (Other Identifier: OHSU Knight Cancer Institute)
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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