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

NCT ID: NCT02724137

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-11-30

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Therapy Rehab and Fitbit®

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

Group Type: EXPERIMENTAL

Fitbit®

Intervention Type: 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

Intervention Type: 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

Standard outpatient physical therapy rehabilitation after total knee replacement.

Group Type: ACTIVE_COMPARATOR

Physical Therapy Rehab

Intervention Type: 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.

Interventions

Fitbit®

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.

Intervention Type: BEHAVIORAL

Physical Therapy Rehab

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Daniel K. White

Dr., PT, ScD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel K White, PT, ScD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

643239-10

Identifier Type: -

Identifier Source: org_study_id