Progressive Resistance Training for the Improvement of Physical Function

Sarcoma Clinical Trial

Official title:

A Resistance Training Program to Improve Physical Function in Sarcoma Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247425
• Other study ID #: STUDY00019942
• Secondary ID: NCI-2019-05865SO
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2022
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sarcoma

Intervention

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

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Number of evaluable participants who completed end-of-intervention assessments	From the time of enrollment up to 3 months end-of-intervention assessments
Primary	Exercise Adherence	Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.	From the time of enrollment up to completion of 12 week exercise intervention
Primary	Frequency of Related Serious Adverse Events (SAEs)	Number of participants that experienced exercise-related SAEs	From the time of enrollment up to completion of 12 week exercise intervention
Secondary	Individualized Progressive Resistance Training (PRT) Prescriptions	Number of participants who received an individualized PRT prescription developed for the participant by the study exercise physiologist.	From the time of enrollment up to completion of 12 week exercise intervention
Secondary	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.	Baseline up to completion of 12 week exercise intervention
Secondary	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.	Baseline up to completion of 12 week exercise intervention
Secondary	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.	Baseline up to completion of 12 week exercise intervention
Secondary	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.	Baseline up to completion of 12 week exercise intervention
Secondary	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.	Baseline up to completion of 12 week exercise intervention
Secondary	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	Baseline up to completion of 12 week exercise intervention
Secondary	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	Baseline up to completion of 12 week exercise intervention
Secondary	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	Baseline up to completion of 12 week exercise intervention
Secondary	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	Baseline up to completion of 12 week exercise intervention
Secondary	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	Baseline up to completion of 12 week exercise intervention
Secondary	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	Baseline up to completion of 12 week exercise intervention