Trial Outcomes & Findings for The PATH Study to Promote Physical Activity After Knee Replacement (NCT NCT03768206)

NCT ID: NCT03768206

Last Updated: 2021-07-21

Results Overview

Feasibility will be determined based on the number of participants enrolled vs. the number approached

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-07-21

Participant Flow

Participant milestones

Measure	PATH PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.	PATH-12 PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Overall Study STARTED	24	21
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	PATH PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.	PATH-12 PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Participants were only included if they had 4 valid days of at least 10 hours of wear time

Baseline characteristics by cohort

Measure	PATH n=24 Participants PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.	PATH-12 n=21 Participants PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=24 Participants	11 Participants n=21 Participants	17 Participants n=45 Participants
Age, Categorical >=65 years	18 Participants n=24 Participants	10 Participants n=21 Participants	28 Participants n=45 Participants
Age, Continuous	67.2 years STANDARD_DEVIATION 5.4 • n=24 Participants	63.3 years STANDARD_DEVIATION 8.1 • n=21 Participants	65.4 years STANDARD_DEVIATION 7.0 • n=45 Participants
Sex: Female, Male Female	16 Participants n=24 Participants	11 Participants n=21 Participants	27 Participants n=45 Participants
Sex: Female, Male Male	8 Participants n=24 Participants	10 Participants n=21 Participants	18 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=24 Participants	21 Participants n=21 Participants	45 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Asian	1 Participants n=24 Participants	0 Participants n=21 Participants	1 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	5 Participants n=24 Participants	8 Participants n=21 Participants	13 Participants n=45 Participants
Race (NIH/OMB) White	18 Participants n=24 Participants	13 Participants n=21 Participants	31 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=45 Participants
Region of Enrollment United States	24 participants n=24 Participants	21 participants n=21 Participants	45 participants n=45 Participants
Moderate-vigorous intensity physical activity	37.8 minutes/week STANDARD_DEVIATION 56.8 • n=22 Participants • Participants were only included if they had 4 valid days of at least 10 hours of wear time	23.5 minutes/week STANDARD_DEVIATION 22.3 • n=17 Participants • Participants were only included if they had 4 valid days of at least 10 hours of wear time	31.5 minutes/week STANDARD_DEVIATION 45.2 • n=39 Participants • Participants were only included if they had 4 valid days of at least 10 hours of wear time

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants analyzed reflects the total number of participants that were approached and screened for participation

Feasibility will be determined based on the number of participants enrolled vs. the number approached

Outcome measures

Measure	Total Participants Approached n=136 Participants The total number of participants that were screened for participation in the study	PATH-12 PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Number of Participants Enrolled	45 Participants	—

PRIMARY outcome

Timeframe: 12 weeks

Acceptability will be determined by the percentage of participants completing the 12 week assessment.

Outcome measures

Measure	Total Participants Approached n=24 Participants The total number of participants that were screened for participation in the study	PATH-12 n=21 Participants PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Percentage of Participants Who Complete the 12 Week Assessment	22 Participants	19 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Only participants with 4 valid days of activity monitor wear (at least 10 hours of wear time) were included in analyses

Total number of minutes of objectively-measured moderate-vigorous intensity (>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.

Outcome measures

Measure	Total Participants Approached n=20 Participants The total number of participants that were screened for participation in the study	PATH-12 n=18 Participants PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
Moderate-Vigorous Intensity Physical Activity	48.5 minutes/week Standard Deviation 55.4	57.4 minutes/week Standard Deviation 62.9

Adverse Events

PATH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATH-12

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

Christine Pellegrini

University of South Carolina

Phone: 803-777-0911

Email: pellegca@mailbox.sc.edu

Results disclosure agreements

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