Knee OsteoarthritisNCT03573141
Influence of Manual Physical Therapy on Habitual Activity in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Brooke Army Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Physical Therapy
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: Military Retirees and dependents receiving care for primary diagnosis of knee osteoarthritis.
Who may be able to join
- 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.
- Participants will have to meet all of the following additional inclusion criteria:
- Age > 38 years old.
- Tricare beneficiary
Show all 10Show fewer
- 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
Who cannot join
- 1.) 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jennifer Moreno Clinic
Fort Sam Houston, Texas, 78234
About this study
Official title: The Relationship of Manual Physical Therapy to Habitual Physical Activity and Sleep Behavior for Patients With Knee Osteoarthritis
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
- Being tested
- Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Subjects received a comprehensive physical therapy evaluation after baseline data collection and received a normal course pf physical therapy treatment based on impairments identified.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: Collected at baseline, 4 weeks and 12 weeks
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.
Measured: Collected at baseline, 4 weeks and 12 weeks
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.
Measured: 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
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
Measured: Collected at baseline, 4 weeks and 12 weeks
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.
Measured: Collected at baseline, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start5 Jan 2018
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Nathan Parsons, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573141
- Sponsor's protocol ID
- C.2017.167
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Manual Physical Therapy to Habitual Physical Activity and Sleep Behavior for Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03573141
- Acronym / sponsor ID
- C.2017.167
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee OA patients receiving Physical Therapy | – | Other: Physical TherapyOnly 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. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Military Retirees and dependents receiving care for primary diagnosis of knee osteoarthritis.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 1.) Presence of any medical "Red Flags" affecting the knee:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapySubjects received a comprehensive physical therapy evaluation after baseline data collection and received a normal course pf physical therapy treatment based on impairments identified. | Other | Knee OA patients receiving Physical Therapy |
Primary outcome
Change in Total Steps Per Day from baseline to 4 weeks and 12 weeks
Time frame: 1 week of monitoring at baseline, 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.
Change in Total Sedentary Time from baseline to 4 weeks and 12 weeks
Time frame: 1 week of monitoring at baseline, 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.
Change in Sleep Efficiency from baseline to 4 weeks and 12 weeks
Time frame: 1 week of monitoring at baseline, 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.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 4 weeks and 12 weeks
Time frame: Collected at baseline, 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.
5 secondary outcomes
Change in 400-meter walk time from baseline to 4 weeks and 12 weeks
Time frame: Collected at baseline, 4 weeks and 12 weeks
Change in 20-meter walk time from baseline to 4 weeks and 12 weeks
Time frame: Collected at baseline, 4 weeks and 12 weeks
Change in Timed Up and Go (TUG) time from baseline to 4 weeks and 12 weeks
Time frame: 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
Time frame: Collected at baseline, 4 weeks and 12 weeks
Change in acceleration while stepping off a curb from baseline to 4 weeks and 12 weeks
Time frame: Collected at baseline, 4 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Steps Per Day from baseline to 4 weeks and 12 weeks (time frame: 1 week of monitoring at baseline, 4 weeks and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.