Clinical trial NCT03573141: Influence of Manual Physical Therapy on Habitual Activity in Knee Osteoarthritis
Official title: The Relationship of Manual Physical Therapy to Habitual Physical Activity and Sleep Behavior for Patients With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2018-06-29
Enrollment: 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Military Retirees and dependents receiving care for primary diagnosis of knee osteoarthritis.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Steps Per Day from baseline to 4 weeks and 12 weeks
timeFrame: 1 week of monitoring at baseline, 4 weeks and 12 weeks
measure: Change in Total Sedentary Time from baseline to 4 weeks and 12 weeks
timeFrame: 1 week of monitoring at baseline, 4 weeks and 12 weeks
measure: Change in Sleep Efficiency from baseline to 4 weeks and 12 weeks
timeFrame: 1 week of monitoring at baseline, 4 weeks and 12 weeks
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 4 weeks and 12 weeks
timeFrame: Collected at baseline, 4 weeks and 12 weeks
Secondary outcomes:
measure: Change in 400-meter walk time from baseline to 4 weeks and 12 weeks
timeFrame: Collected at baseline, 4 weeks and 12 weeks
measure: Change in 20-meter walk time from baseline to 4 weeks and 12 weeks
timeFrame: Collected at baseline, 4 weeks and 12 weeks
measure: Change in Timed Up and Go (TUG) time from baseline to 4 weeks and 12 weeks
timeFrame: Collected at baseline, 4 weeks and 12 weeks
measure: Change in Five Times Sit to Stand(5TSTS)time from from baseline to 4 weeks and 12 weeks
timeFrame: Collected at baseline, 4 weeks and 12 weeks
measure: Change in acceleration while stepping off a curb from baseline to 4 weeks and 12 weeks
timeFrame: Collected at baseline, 4 weeks and 12 weeks
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Jennifer Moreno Clinic
state: Texas
Study officials:
References: