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Group Physical Therapy for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01058304
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : March 24, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Osteoarthritis
Interventions: Other: Group Physical Therapy for Knee OA
Other: Individual Physical Therapy for Knee OA

  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
Group Physical Therapy for Knee OA

Group Physical Therapy for Knee OA

Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.

Individual Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.


Participant Flow:   Overall Study
    Group Physical Therapy for Knee OA   Individual Physical Therapy for Knee OA
STARTED   159   161 
COMPLETED   132   128 
NOT COMPLETED   27   33 
Withdrawal by Subject                8                5 
Lost to Follow-up                13                16 
Developed exclusion criterion                6                12 



  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.
All enrolled, randomized participants

Reporting Groups
  Description
Group Physical Therapy for Knee OA

Group Physical Therapy for Knee OA

Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.

Individual Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.

Total Total of all reporting groups

Baseline Measures
   Group Physical Therapy for Knee OA   Individual Physical Therapy for Knee OA   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   161   320 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.2  (9.6)   60.8  (10.0)   60.0  (9.8) 
Gender 
[Units: Participants]
     
Female   18   20   38 
Male   141   141   282 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   68   68   136 
Non-White   91   93   184 
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 44.2  (14.9)   43.3  (14.5)   43.7  (14.7) 
[1] WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms.
Short Performance Physical Battery (SPPB) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.2  (1.9)   9.1  (2.1)   9.1  (2.0) 
[1] This battery of objective physical function tests examines participants’ balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function.


  Outcome Measures

1.  Primary:   Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)   [ Time Frame: 12-weeks, 24-weeks ]

2.  Secondary:   Short Performance Physical Battery (SPPB)   [ Time Frame: 12 weeks ]


  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
Because the target recruitment goal could not be met, a new sample size target was calculated, with a goal of being able to detect an effect size of 0.35. This translated into a target of n=226, which we exceeded by enrolling n=320.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kelli D. Allen
Organization: Health Services Research & Development, Durham VAMC
phone: 919-286-0411 ext 7090
e-mail: kelli.allen@va.gov


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01058304     History of Changes
Other Study ID Numbers: IIR 09-056
First Submitted: January 26, 2010
First Posted: January 28, 2010
Results First Submitted: March 12, 2015
Results First Posted: March 24, 2015
Last Update Posted: April 14, 2015