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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724137
• Other study ID #: 643239-10
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short term adherence to treatment as measured by physical therapist.	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.
Secondary	Self report long-term adherence to treatment as measured by research assistant.	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).	6 months after discharge from physical therapy rehab
Secondary	Reporting of adverse events	This time frame is open-ended by design. The goal is to model our trial off of 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.
Secondary	Number participants excluded from study as measured by research assistant.	Number of participants that do not meet inclusion criteria.	At initial physical therapy evaluation.
Secondary	Reason why the participant was excluded from the study.	Categories: 1) no time/too busy 2) too much trouble 3) illness (self) 4) illness family 5) not interested 6) concerned about injury/pain 7) concerned about quality of care 8) refused	At initial physical therapy evaluation.
Secondary	Self reported kinesiophobia using the Tampa-15 Scale for Kinesiophobia.	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.
Secondary	Self reported self-efficacy using the Self-Efficacy Scale for Exercise.	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.
Secondary	Intervention Fidelity using electronic medical records and digital audio recordings.	The goal is to investigate how consistent the physical activity intervention is provided to the patients. Consistency will be measured using two methods. The first is to use the EMR to check if current steps/day were recorded by the treating PT. The second is to use the digital audio recording in a subset of patients to evaluate if steps/day from the past week were reviewed by the treating PT, and if a step goal was discussed for the next week. 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).	During outpatient physical therapy rehab which is expected to be 8 weeks.
Secondary	Self reported pain catastrophizing using the Pain Catastrophizing Scale (PSC)	This time frame is open-ended by design. Our 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.