Progressive Resistance Training for the Improvement of Physical Function

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04247425
• Collaborator: National Cancer Institute (NCI) (NIH), Oregon Health and Science University (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 26.2
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Other: Exercise Counseling; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training	N/A

Detailed Description

PRIMARY OBJECTIVE:

1. To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors.

SECONDARY OBJECTIVES:

1. To assess secondary measures of feasibility of a home-based, individualized PRT program in sarcoma survivors.

2. To determine if a 3-month PRT program improves physical function in sarcoma survivors.

EXPLORATORY OBJECTIVE:

1. 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

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
• Actual Study Start Date: Jun 28, 2019
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

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.	Other: Exercise Counseling; Receive instructional guidance; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment ; Other: Questionnaire Administration; Ancillary studies; Other: Resistance Training; Complete progressive resistance training; Other Names: Strength Training

Outcome Measures

Primary Outcome Measures

1. Retention [From the time of enrollment up to 3 months end-of-intervention assessments]

   Number of evaluable participants who completed end-of-intervention assessments

2. Exercise Adherence [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.

3. Frequency of Related Serious Adverse Events (SAEs) [From the time of enrollment up to completion of 12 week exercise intervention]

   Number of participants that experienced exercise-related SAEs

Secondary Outcome Measures

1. Individualized Progressive Resistance Training (PRT) Prescriptions [From the time of enrollment up to completion of 12 week exercise intervention]

   Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.

2. Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value [Baseline up to completion of 12 week exercise intervention]

   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.

3. Change in Short Form-36 Physical Function Score [Baseline up to completion of 12 week exercise intervention]

   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.

4. Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) [Baseline up to completion of 12 week exercise intervention]

   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.

5. Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) [Baseline up to completion of 12 week exercise intervention]

   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.

6. Difference in 1-repetition Maximum (Kilogram) [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.

7. Change in Short Physical Performance Battery Score [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

8. Change in Grip Strength (Kilogram) [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

9. Change in Gait and Balance [Baseline up to completion of 12 week exercise intervention]

   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

10. Change in Instrumented 6-minute Walk Test [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

11. Change in Instrumented Postural Sway [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

12. Change in Instrumented Timed up and go Test [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• National Cancer Institute (NCI)
• Oregon Health and Science University

Investigators

• Principal Investigator: Lara E Davis, OHSU Knight Cancer Institute

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Apr 16, 2020

More Information

Publications

None provided.

• Responsible Party: Lara Davis, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT04247425
• Other Study ID Numbers: STUDY00019942; NCI-2019-05865; SOL-19103-L; STUDY00019942; P30CA069533
• First Posted: Jan 30, 2020
• Last Update Posted: Aug 8, 2022
• Last Verified: Jul 1, 2022

• 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
• Additional relevant MeSH terms: Sarcoma

Study Results

Participant Flow

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Period Title: Overall Study
STARTED	10
COMPLETED	9
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 90%
>=65 years	1 10%
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	9 90%
Unknown or Not Reported	1 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	10 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Count of Participants [Participants]	9 90%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	9
Count of Participants [Participants]	7 70%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Count of Participants [Participants]	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Count of Participants [Participants]	10 100%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Baseline	45.6 (9.4)
End of Treatment	47.2 (8.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Resistance Training, Exercise Counseling)
	Comments	Baseline compared to end of 12 week exercise intervention
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Baseline	43.3 (8.4)
End of Treatment	49.1 (6.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Resistance Training, Exercise Counseling)
	Comments	Baseline compared to end of 12 week exercise intervention
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Baseline	28.6 (32.9)
End of Treatment	20.8 (12.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Resistance Training, Exercise Counseling)
	Comments	Baseline compared to end of 12 week exercise intervention
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	10
Baseline	30.2 (14.8)
End of Treatment	40.1 (10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Supportive Care (Resistance Training, Exercise Counseling)
	Comments	Baseline compared to end of 12 week exercise intervention
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data could not be collected due to COVID restrictions

Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
Measure Participants	0

Adverse Events

Time Frame	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.
Arm/Group Title	Supportive Care (Resistance Training, Exercise Counseling)
Arm/Group 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
All Cause Mortality
	Supportive Care (Resistance Training, Exercise Counseling)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Supportive Care (Resistance Training, Exercise Counseling)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Supportive Care (Resistance Training, Exercise Counseling)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

The COVID pandemic resulted in extensive protocol revisions to pivot from in person assessments to telehealth. Multiple secondary endpoints were therefore not collected

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.