SarcomaNCT04247425
Progressive Resistance Training for the Improvement of Physical Function
A study testing Exercise Counseling, Quality-of-Life Assessment and Questionnaire Administration in people with Sarcoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Exercise Counseling, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Sarcoma
- Being tested
- Exercise Counseling, Quality-of-Life Assessment, Questionnaire Administration, Resistance Training
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CounselingOther
Receive instructional guidance
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Resistance TrainingOther
Also called Strength Training
Complete progressive resistance training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Counseling; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Number of evaluable participants who completed end-of-intervention assessments
Measured: 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.
Measured: 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
Measured: From the time of enrollment up to completion of 12 week exercise intervention
Secondary outcomes (12)
Individualized Progressive Resistance Training (PRT) Prescriptions
Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to completion of 12 week exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start28 Jun 2019
- Primary completion1 Jan 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Responsible party
- Principal investigator, Lara Davis, OHSU Knight Cancer Institute
- Investigators
- Lara E Davis, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247425
- Sponsor's protocol ID
- STUDY00019942
- Other IDs
- NCI-2019-05865, SOL-19103-L, STUDY00019942, P30CA069533
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2020
- Last updated
- 8 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42343234
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
- ClinicalTrials.gov ID
- NCT04247425
- Acronym / sponsor ID
- STUDY00019942
- Conditions
- Sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 8 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (resistance training, exercise counseling) | Experimental | Other: Exercise Counseling, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Resistance TrainingPatients 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise CounselingReceive instructional guidance | Other | Supportive Care (resistance training, exercise counseling) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (resistance training, exercise counseling) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (resistance training, exercise counseling) |
| Resistance TrainingAlso: Strength TrainingComplete progressive resistance training | Other | Supportive Care (resistance training, exercise counseling) |
Primary outcome
Retention
Time frame: From the time of enrollment up to 3 months end-of-intervention assessments
Number of evaluable participants who completed end-of-intervention assessments
Exercise Adherence
Time frame: From the time of enrollment up to completion of 12 week exercise intervention
Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.
Frequency of Related Serious Adverse Events (SAEs)
Time frame: From the time of enrollment up to completion of 12 week exercise intervention
Number of participants that experienced exercise-related SAEs
12 secondary outcomes
Individualized Progressive Resistance Training (PRT) Prescriptions
Time frame: 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
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Short Form-36 Physical Function Score
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)
Time frame: Baseline up to completion of 12 week exercise intervention
Difference in 1-repetition Maximum (Kilogram)
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Short Physical Performance Battery Score
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Grip Strength (Kilogram)
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Gait and Balance
Time frame: 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
Change in Instrumented Postural Sway
Time frame: Baseline up to completion of 12 week exercise intervention
Change in Instrumented Timed up and go Test
Time frame: Baseline up to completion of 12 week exercise intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42343234Davis 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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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.
Lara E Davis principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Counseling, Quality-of-Life Assessment and Questionnaire Administration in people with Sarcoma, run by OHSU Knight Cancer 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 8 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention (time frame: From the time of enrollment up to 3 months end-of-intervention assessments). 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?
On the ClinicalTrials.gov record for NCT04247425, which also lists 1 linked publication.
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 Aug 2022.