Influence of Manual Physical Therapy on Habitual Activity in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Relationship of Manual Physical Therapy to Habitual Physical Activity and Sleep Behavior for Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03573141
• Other study ID #: C.2017.167
• Status: Active, not recruiting
• Start date: January 5, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2018
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators assessed overall physical activity and sleep quality in subjects with knee osteoarthritis(OA) at baseline, and at four and 12 weeks following initiation of physical therapy. Subjects received a course of manual physical therapy with interventions targeted to relevant impairments in the lower quarter. No progressive activity intervention or guidance on sleep hygiene was included. The purpose of this study was to assess a relationship between manual physical therapy and habitual physical activity and sleep behavior in individuals with knee OA.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Knee pain and crepitus with active motion and morning stiffness < 30 minutes and age > 38 years old.

2. Knee pain and crepitus with active motion and morning stiffness < 30 minutes and bony enlargement.

3. Knee pain and no crepitus and bony enlargement.

Participants will have to meet all of the following additional inclusion criteria:

1. Age > 38 years old.

2. Tricare beneficiary

3. Ability to read and speak English well enough to provide informed consent and follow study instructions

4. Knee OA is the participant's most physically limiting condition as determined by patient's self report.

5. Able to ambulate 20 meters (65.6 feet) feet without an assistive device.

6. Radiographic findings of knee OA

Exclusion Criteria:

• 1.) Presence of any medical "Red Flags" affecting the knee:

1. Tumor, neoplasm etc. affecting the knee

2. Current or past history of rheumatoid arthritis or similar rheumatic condition

3. Current or past history of gout or pseudogout affecting the knee

4. Active Infection in the knee within the past 12 months

2.) Inability to participate in the therapy plan prescribed by the treating therapist 3.) Any prior Physical Therapy for the knee in the past 12 months 4.) Injection to the knee joint within the previous 30 days 5.) Surgical procedure on either lower extremity within the past 6 months 6.) Any prior lower extremity joint replacement surgery 7.) A physical impairment unrelated to the knee that prevents the subject from safely participating in any aspect of the study 8.) History of cardiac, respiratory, or musculoskeletal disorders (e.g. amputation) that restrict lower extremity function. 9.) Any physical, psychological, or emotional condition that is more symptom producing, or activity limiting than their knee OA.

10.) Any condition that disrupts sleep more than knee OA, such as a sleep disorder or Obstructive Sleep Apnea 11.) Inability to speak/read English adequately to understand and provide informed consent 12.) Pregnant or intending to become pregnant in the next year 13.) Military service members in a WTU (Warriors in Transition Unit) or service equivalent or pending a medical evaluation board/discharge process. For non-military personnel, anyone that is pending or undergoing any litigation. 14.) WOMAC Score < 30 15.) Unable to provide informed consent to participate in the study

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Physical Therapy
Subjects received a comprehensive physical therapy evaluation after baseline data collection and received a normal course pf physical therapy treatment based on impairments identified.

Locations

Country	Name	City	State
United States	Jennifer Moreno Clinic	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Steps Per Day from baseline to 4 weeks and 12 weeks	Steps per day were measured with an ActiGraph accelerometer (model wGT9X Link), ActiGraph Corp., Pensacola FL). The ActiGraph accelerometer measures triaxial acceleration and provides information about the intensity and duration of the physical activity associated with movement.	1 week of monitoring at baseline, 4 weeks and 12 weeks
Primary	Change in Total Sedentary Time from baseline to 4 weeks and 12 weeks	Total Sedentary Time was measured with an ActiGraph accelerometer (model wGT9X Link), ActiGraph Corp., Pensacola FL). The ActiGraph accelerometer measures triaxial acceleration and provides information about the intensity and duration of the physical activity associated with movement. Total time spent in sedentary was calculated based on established on established cut points, reported in minutes per day and converted to a percentage of daily activity. Higher percentage indicated more time spent in sedentary behavior.	1 week of monitoring at baseline, 4 weeks and 12 weeks
Primary	Change in Sleep Efficiency from baseline to 4 weeks and 12 weeks	Sleep efficiency is defined as the total sleep time relative to the time in bed. Higher scores indicated better sleep efficiency, with scores above 85 considered to be in the normal range. Sleep monitoring was performed using the Micro Motionlogger Sleep Watch (Ambulatory Monitoring Inc., Ardsley, NY) on the non-dominant wrist.	1 week of monitoring at baseline, 4 weeks and 12 weeks
Primary	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 4 weeks and 12 weeks	The primary patient-reported outcome was the Western Ontario and McMaster's University Arthritis Index(WOMAC). It is a widely used, proprietary standardized questionnaire used by health professionals to evaluate the condition of patients with OA of the knee and hip, including pain, stiffness, and physical functioning. This scale runs from 0 to 240 points with lower scores indicating improved symptoms and function.	Collected at baseline, 4 weeks and 12 weeks
Secondary	Change in 400-meter walk time from baseline to 4 weeks and 12 weeks	The 400-meter walk test was administered to quantify walking endurance. The test was conducted a 100-meter-long course with four lengths being completed. Timing using a digital stopwatch began from the initial movement from standing at the start until the subject completed the fourth length of the course. Total time (sec) was recorded, with longer time indicating worse physical function	Collected at baseline, 4 weeks and 12 weeks
Secondary	Change in 20-meter walk time from baseline to 4 weeks and 12 weeks	The 20-meter walk test was performed in a hallway located in the PT Clinic which was free from any potential barriers to ambulation. The 20-meter walk course was clearly marked with bright cones at each end. Participants were instructed to wear their regular footwear and to use any assistive devices they normally use for ambulation. Total time (sec) was recorded and converted to meters per second, with a lower value indicating worse physical function.	Collected at baseline, 4 weeks and 12 weeks
Secondary	Change in Timed Up and Go (TUG) time from baseline to 4 weeks and 12 weeks	The TUG is a simple test of mobility designed to assess dynamic balance. Participants were expected to wear their regular footwear and use any assistive devices they normally use for ambulation. Total time (sec) was recorded with a lower value indicating worse physical function.	Collected at baseline, 4 weeks and 12 weeks
Secondary	Change in Five Times Sit to Stand(5TSTS)time from from baseline to 4 weeks and 12 weeks	The 5TSTS was used to determine lower extremity functional strength. Participants were instructed to stand from a chair and return to sitting five times as quickly as possible with arms folded across the chest. Total time in seconds was measured with a digital stopwatch and started with initial movement to stand on the first repetition and ended after completely standing upright on the 5th repetition, with longer time indicating worse physical function	Collected at baseline, 4 weeks and 12 weeks
Secondary	Change in acceleration while stepping off a curb from baseline to 4 weeks and 12 weeks	Vertical acceleration forces were measured with Shimmer3 monitors (Shimmer Sensing, Dublin, Ireland) at the waist and lower leg in order to assess instrumented evaluation of stepping off a raised platform while walking. This task is ubiquitous in daily activity throughout the lifespan. There is no greater risk with this test than stepping off a typical curb. Participants completed the task under close supervision by research staff by stepping down from a 20 cm raised platform in the PT clinic to simulate a curb. 5 trials were completed with both lower extremities at each time point.	Collected at baseline, 4 weeks and 12 weeks