A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Pilot Study

NCT02724137 | Completed DMC

• 1 other identifier: 643239-10
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 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. 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. 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. 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.

Conditions

Physical Activity

Keywords

Total Knee Replacement; Physical Therapy; Fitbit®

Outcome Measures

Primary Outcomes (1)

• Physical activity measured by the Actigraph GT3X monitor

  This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).

  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 (9)

• Short term adherence to treatment as measured by physical therapist.

  Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.

• Self report long-term adherence to treatment as measured by research assistant.

  6 months after discharge from physical therapy rehab

• Reporting of adverse events

  Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.

• Number participants excluded from study as measured by research assistant.

  At initial physical therapy evaluation.

• Reason why the participant was excluded from the study.

  At initial physical therapy evaluation.

Study Arms (2)

Physical Therapy Rehab and Fitbit®

EXPERIMENTAL

Standard outpatient physical therapy rehabilitation after total knee replacement with the addition of a Fitbit® to promote physical activity.

Behavioral: Fitbit®; Other: Physical Therapy Rehab

Physical Therapy Rehab

ACTIVE COMPARATOR

Standard outpatient physical therapy rehabilitation after total knee replacement.

Other: Physical Therapy Rehab

Interventions

Fitbit® BEHAVIORAL

Participants can read how many steps/day they walked on the Fitbit® daily. The treating physical therapist reviews Fitbit® recorded steps from the previous week and together with the patient sets a new step goal. The physical therapist discusses barriers to meeting step goals are discussed. Self-reward for meeting step/goal is set weekly. Participants in this group will also receive 1-month phone calls for 6-months after completing physical therapy rehabilitation to discuss physical activity, set monthly step count goal, barriers to overcoming goal and to continue to develop a reward system for when the participant achieves their step count goal.

Physical Therapy Rehab and Fitbit®

Physical Therapy Rehab OTHER

Standard of care physical therapy after total knee replacement. The goals of physical therapy are to increase knee range of motion and strength, improve balance and agility, and increase daily walking. Physical therapy appointment times range from 45-60 minutes with appointments occurring 2 times a week for 6-8 weeks.

Physical Therapy Rehab; Physical Therapy Rehab and Fitbit®

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Daniel K White, PT, ScD, MSc

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., PT, ScD, MSc

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 31, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)