Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

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.

Exercise Counseling

Quality-of-Life Assessment

Questionnaire Administration

Resistance Training

Lara E Davis

This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an independent lifestyle. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

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

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

EXPLORATORY OBJECTIVE:

I. To determine if a 3 month resistance training program improves body composition and bone mineral density.

OUTLINE:

Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.

After completion of study, patients are followed up at 3 months.

Progressive Resistance Training for the Improvement of Physical Function

A Resistance Training Program to Improve Physical Function in Sarcoma Survivors

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

Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.

Number of participants that experienced exercise-related SAEs

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

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.

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.

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.

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.

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.

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 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

National Cancer Institute (NCI)

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

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

Supportive Care (Resistance Training, Exercise Counseling)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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

Lara Davis, MD

Retention

Exercise Adherence

Frequency of Related Serious Adverse Events (SAEs)

Individualized Progressive Resistance Training (PRT) Prescriptions

Baseline compared to end of 12 week exercise intervention

Spots Global Cancer Trial Database for Progressive Resistance Training for the Improvement of Physical Function

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial