Influence of Manual Physical Therapy on Habitual Activity in Knee Osteoarthritis

NCT03573141 | Unknown

• 1 other identifier: C.2017.167
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Change in 400-meter walk time from baseline to 4 weeks and 12 weeks

  Collected at baseline, 4 weeks and 12 weeks

• Change in 20-meter walk time from baseline to 4 weeks and 12 weeks

  Collected at baseline, 4 weeks and 12 weeks

• Change in Timed Up and Go (TUG) time from baseline to 4 weeks and 12 weeks

  Collected at baseline, 4 weeks and 12 weeks

• Change in Five Times Sit to Stand(5TSTS)time from from baseline to 4 weeks and 12 weeks

  Collected at baseline, 4 weeks and 12 weeks

• Change in acceleration while stepping off a curb from baseline to 4 weeks and 12 weeks

  Collected at baseline, 4 weeks and 12 weeks

Study Arms (1)

Knee OA patients receiving Physical Therapy

Only 1 group was included in this study. Subject's physical activity and sleep quality were assessed at baseline, prior to treatment. Follow up data was collected immediately after a course of physical therapy then again 8 weeks later.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

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

Knee OA patients receiving Physical Therapy

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Military Retirees and dependents receiving care for primary diagnosis of knee osteoarthritis.

You may qualify if:

• Knee pain and crepitus with active motion and morning stiffness \< 30 minutes and age \> 38 years old.
• Knee pain and crepitus with active motion and morning stiffness \< 30 minutes and bony enlargement.
• Knee pain and no crepitus and bony enlargement.
• Age \> 38 years old.
• Tricare beneficiary
• Ability to read and speak English well enough to provide informed consent and follow study instructions
• Knee OA is the participant's most physically limiting condition as determined by patient's self report.
• Able to ambulate 20 meters (65.6 feet) feet without an assistive device.
• Radiographic findings of knee OA

You may not qualify if:

• ) Presence of any medical "Red Flags" affecting the knee:
• Tumor, neoplasm etc. affecting the knee
• Current or past history of rheumatoid arthritis or similar rheumatic condition
• Current or past history of gout or pseudogout affecting the knee
• Active Infection in the knee within the past 12 months
• ) 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.
• ) 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Jennifer Moreno Clinic

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Fellow-in-Training, Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 29, 2018
• Study Start: January 5, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)