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Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis (PATH-IN)

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ClinicalTrials.gov Identifier: NCT02312713
Recruitment Status : Completed
First Posted : December 9, 2014
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Osteoarthritis
Interventions: Behavioral: Internet Based Exercise Training
Behavioral: Physical Therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Physical Therapy

Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.

Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.

Internet Based Exercise Training

Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.

Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.

Wait List Control no intervention

Participant Flow:   Overall Study
    Standard Physical Therapy   Internet Based Exercise Training   Wait List Control
STARTED   140   142   68 
COMPLETED   129   112   63 
NOT COMPLETED   11   30   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Physical Therapy

Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be “semi-standardized,” meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.

Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.

Internet Based Exercise Training

Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals’ functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.

Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.

Wait List Control no intervention
Total Total of all reporting groups

Baseline Measures
   Standard Physical Therapy   Internet Based Exercise Training   Wait List Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 140   142   68   350 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.7  (10.3)   65.3  (11.5)   64.3  (12.2)   65.3  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      40  28.6%      44  31.0%      15  22.1%      99  28.3% 
Male      100  71.4%      98  69.0%      53  77.9%      251  71.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      4   2.9%      4   2.8%      1   1.5%      9   2.6% 
Not Hispanic or Latino      134  95.7%      138  97.2%      67  98.5%      339  96.9% 
Unknown or Not Reported      2   1.4%      0   0.0%      0   0.0%      2   0.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      1   0.7%      1   0.7%      1   1.5%      3   0.9% 
Asian      1   0.7%      8   5.6%      2   2.9%      11   3.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.7%      1   1.5%      2   0.6% 
Black or African American      24  17.1%      33  23.2%      13  19.1%      70  20.0% 
White      109  77.9%      94  66.2%      49  72.1%      252  72.0% 
More than one race      1   0.7%      2   1.4%      1   1.5%      4   1.1% 
Unknown or Not Reported      4   2.9%      3   2.1%      1   1.5%      8   2.3% 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 31.9  (8.6)   31.5  (7.8)   30.1  (7.3)   31.4  (8.0) 
Married or Living with Partner 
[Units: Participants]
Count of Participants
 80   93   42   215 
Bachelors Degree or More Education 
[Units: Participants]
Count of Participants
 86   80   42   208 
Employed 
[Units: Participants]
Count of Participants
 59   51   31   141 
Low Income Financial Status [1] 
[Units: Participants]
Count of Participants
 20   29   13   62 
[1] "Low income" defined as self report of “just meeting basic expenses” or “don’t even have enough to meet basic expenses" vs. responses of "live comfortably or "meet your basic expenses with a little left over for extras" in response to a question asking participants to "describe your household’s financial situation."
Fair or Poor Self-Reported Health [1] 
[Units: Participants]
Count of Participants
 14   22   12   48 
[1]

Participants were asked, "How would you rate your current health?" Options were: excellent, very good, good, fair and poor.

For this metric we grouped those reporting fair or poor.

Number of Joints with Arthritis Symptoms 
[Units: Joints]
Mean (Standard Deviation)
 5.5  (3.0)   5.2  (3.1)   5.5  (3.9)   5.4  (3.2) 
Self-reported Years with Arthritis Symptoms 
[Units: Years]
Mean (Standard Deviation)
 14.1  (11.6)   11.6  (11.0)   14.2  (13.0)   13.1  (11.7) 


  Outcome Measures

1.  Primary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score   [ Time Frame: baseline, 4 months, and 12 months ]

2.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale   [ Time Frame: baseline, 4 months, and 12 months ]

3.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test   [ Time Frame: baseline, 4 months, and 12 months ]

4.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time   [ Time Frame: baseline, 4 months, and 12 months ]

5.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand   [ Time Frame: baseline, 4 months, and 12 months ]

6.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go   [ Time Frame: baseline, 4 months, and 12 months ]

7.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8   [ Time Frame: baseline, 4 months, and 12 months ]

8.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)   [ Time Frame: baseline, 4 months, and 12 months ]

9.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument   [ Time Frame: baseline, 4 months, and 12 months ]

10.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument   [ Time Frame: baseline, 4 months, and 12 months ]

11.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale   [ Time Frame: baseline, 4 months, and 12 months ]

12.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)   [ Time Frame: baseline, 4 months, and 12 months ]

13.  Secondary:   Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items   [ Time Frame: baseline, 4 months, and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
1.) No new radiographs were conducted. 2) No assessment of adherence to home exercise. 3) This study was conducted in one geographic region and only included participants with regular internet access, which may limit generalizability.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kelli Allen
Organization: University of North Carolina at Chapel HIll
phone: 919-966-0558
e-mail: kdallen@email.unc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02312713     History of Changes
Other Study ID Numbers: 14-1331
First Submitted: October 20, 2014
First Posted: December 9, 2014
Results First Submitted: August 21, 2017
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017