Back to resultsProgressive Resistance Training for the Improvement of Physical Function
Primary Purpose
Sarcoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Counseling
Quality-of-Life Assessment
Questionnaire Administration
Resistance Training
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcoma
Eligibility Criteria
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)
Sites / Locations
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (resistance training, exercise counseling)
Arm Description
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.
Outcomes
Primary Outcome Measures
Retention
Number of evaluable participants who completed 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.
Frequency of Related Serious Adverse Events (SAEs)
Number of participants that experienced exercise-related SAEs
Secondary Outcome Measures
Individualized Progressive Resistance Training (PRT) Prescriptions
Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.
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.
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.
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.
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.
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.
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
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
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
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
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
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
Full Information
NCT ID
NCT04247425
First Posted
January 24, 2020
Last Updated
July 12, 2022
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04247425
Brief Title
Progressive Resistance Training for the Improvement of Physical Function
Official Title
A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (resistance training, exercise counseling)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Counseling
Intervention Description
Receive instructional guidance
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Strength Training
Intervention Description
Complete progressive resistance training
Primary Outcome Measure Information:
Title
Retention
Description
Number of evaluable participants who completed end-of-intervention assessments
Time Frame
From the time of enrollment up to 3 months end-of-intervention assessments
Title
Exercise Adherence
Description
Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.
Time Frame
From the time of enrollment up to completion of 12 week exercise intervention
Title
Frequency of Related Serious Adverse Events (SAEs)
Description
Number of participants that experienced exercise-related SAEs
Time Frame
From the time of enrollment up to completion of 12 week exercise intervention
Secondary Outcome Measure Information:
Title
Individualized Progressive Resistance Training (PRT) Prescriptions
Description
Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.
Time Frame
From the time of enrollment up to completion of 12 week exercise intervention
Title
Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value
Description
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.
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Short Form-36 Physical Function Score
Description
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.
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)
Description
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.
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)
Description
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.
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Difference in 1-repetition Maximum (Kilogram)
Description
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.
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Short Physical Performance Battery Score
Description
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
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Grip Strength (Kilogram)
Description
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
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Gait and Balance
Description
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
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Instrumented 6-minute Walk Test
Description
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
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Instrumented Postural Sway
Description
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
Time Frame
Baseline up to completion of 12 week exercise intervention
Title
Change in Instrumented Timed up and go Test
Description
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
Time Frame
Baseline up to completion of 12 week exercise intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara E Davis
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Progressive Resistance Training for the Improvement of Physical Function
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