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

University of Delaware

Status: Completed

Conditions: Physical Activity

Treatments: Behavioral: Fitbit®; Other: Physical Therapy Rehab

Study type: Interventional

Funder types: Other

Identifiers

NCT02724137

643239-10

Details and patient eligibility

About

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.

Full description

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

Enrollment: 43 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Physical Therapy Rehab and Fitbit®

Experimental group

Description:

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

Treatment:

Behavioral: Fitbit®

Other: Physical Therapy Rehab

Physical Therapy Rehab

Active Comparator group

Description:

Standard outpatient physical therapy rehabilitation after total knee replacement.

Treatment:

Other: Physical Therapy Rehab