Trial Outcomes & Findings for Progressive Resistance Training for the Improvement of Physical Function (NCT NCT04247425)

NCT ID: NCT04247425

Last Updated: 2022-08-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: From the time of enrollment up to 3 months end-of-intervention assessments
• Results posted on: 2022-08-08

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progressive Resistance Training for the Improvement of Physical Function

Baseline characteristics by cohort

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: From the time of enrollment up to 3 months end-of-intervention assessments

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

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Retention	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=9 Participants 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 Adherence	7 Participants

PRIMARY outcome

Timeframe: From the time of enrollment up to completion of 12 week exercise intervention

Number of participants that experienced exercise-related SAEs

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Frequency of Related Serious Adverse Events (SAEs)	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Individualized Progressive Resistance Training (PRT) Prescriptions	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value Baseline	45.6 score on a scale Standard Deviation 9.4
Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value End of Treatment	47.2 score on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Change in Short Form-36 Physical Function Score Baseline	43.3 score on a scale Standard Deviation 8.4
Change in Short Form-36 Physical Function Score End of Treatment	49.1 score on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) Baseline	28.6 arbitrary units Standard Deviation 32.9
Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ) End of Treatment	20.8 arbitrary units Standard Deviation 12.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (Resistance Training, Exercise Counseling) n=10 Participants 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
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) Baseline	30.2 score on a scale Standard Deviation 14.8
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F) End of Treatment	40.1 score on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to completion of 12 week exercise intervention

Population: Data could not be collected due to COVID restrictions

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

Outcome measures

Outcome data not reported

Adverse Events

Supportive Care (Resistance Training, Exercise Counseling)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lara Davis, MD

Oregon Health & Science University

Phone: 5034948423

Email: davisla@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place