Clinical trial NCT02724137: A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Pilot Study
Official title: A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Total Knee Replacement
Physical Therapy
Fitbit®
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 43
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to:

1. Determine whether the Physical Therapy (PT) \& Fitbit® intervention should proceed to a full-scale clinical trial. This decision will be based on three hypotheses: Treatment promise (Hypothesis 1A): People in the PT \& Fitbit® will walk 1250 more steps/day and spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control at discharge and at 6 months and 12 months, Safety (Hypothesis 1B): \< 5% will have adverse events because of the intervention, A research assistant will collect data on adverse events that occur from the time of randomization until the last follow-up visit 3 months after discharge from PT. An adverse event is any unfavorable or unintended diagnosis, sign, symptom, or disease temporarily associated with the study intervention, which may or may not be related to the intervention. Adverse events include any new events not present during the pre-intervention period or events that were present during the pre-intervention period which have increased in severity. Major adverse events, such as infection, re-hospitalization or development of new comorbidities will also be noted. Recruitment (Hypothesis 1C): 75 recruited, 90% to complete trial, and 85% complete visit at 6 months and 12 months.
2. To evaluate the short- and long-term adherence of the PT \& Fitbit® intervention. Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT\& Fitbit® group will wear the Fitbit® and participate in goal setting and behavioral counseling while in PT. Long-term Adherence (Hypothesis 2B): 75% of PT \& Fitbit® will wear the Fitbit® at 6 months and 12 months.
3. To quantify changes in potential underlying mechanisms for increased physical activity. (Hypothesis 3): Change in self-efficacy for physical activity, walking endurance and participation in daily activities will be associated with improvements in physical activity.
4. To assess intervention fidelity (Hypothesis 4): (4a) using the electronic medical record, the treating PT will check off that they 1) reviewed physical activity recorded by the Fitbit® and 2) discussed step goals for all study subjects randomized to the intervention group. (4b) treating PTs will be asked to audio record five-intervention interactions/week using a digital audio recorder. A research assistant will then assess whether the PT 1) reviewed physical activity and 2) discussed step goals. Lastly, the duration of the intervention will be noted.

Detailed description: The study is a pilot study to determine the feasibility of a full trial.

Eligibility criteria: Inclusion Criteria:

* Over the age of 45
* Seeking outpatient physical therapy after unilateral TKR

Exclusion Criteria:

* Not interested in increasing physical activity
* Co-morbidities other than unilateral TKR that limit physical activity
* Planning on having another lower extremity surgery in the next 6 months
* Have had another lower extremity surgery in the past 6 months

Primary outcomes:
measure: Physical activity measured by the Actigraph GT3X monitor
timeFrame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. Also at 6-months and 12-months from discharge from physical therapy rehab.
Secondary outcomes:
measure: Short term adherence to treatment as measured by physical therapist.
timeFrame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
measure: Self report long-term adherence to treatment as measured by research assistant.
timeFrame: 6 months after discharge from physical therapy rehab
measure: Reporting of adverse events
timeFrame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
measure: Number participants excluded from study as measured by research assistant.
timeFrame: At initial physical therapy evaluation.
measure: Reason why the participant was excluded from the study.
timeFrame: At initial physical therapy evaluation.
measure: Self reported kinesiophobia using the Tampa-15 Scale for Kinesiophobia.
timeFrame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
measure: Self reported self-efficacy using the Self-Efficacy Scale for Exercise.
timeFrame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
measure: Intervention Fidelity using electronic medical records and digital audio recordings.
timeFrame: During outpatient physical therapy rehab which is expected to be 8 weeks.
measure: Self reported pain catastrophizing using the Pain Catastrophizing Scale (PSC)
timeFrame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Daniel K White, PT, ScD, MSc
role: PRINCIPAL_INVESTIGATOR
References: