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Yoga for Managing Knee Osteoarthritis in Older Women: a Feasibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832155
First Posted: April 15, 2013
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The John A. Hartford Foundation
Midwest Nursing Center Consortium Research Network
University of St Catherine St Paul MN
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: July 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Conditions: Osteoarthritis, Knee
Quality of Life
Poor Quality Sleep
Physical Impairment
Interventions: Behavioral: Hatha yoga
Behavioral: Hatha Yoga

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took 9 months through placing flyers in various community centers; distributing press releases to the University’s Alumnae Newsletter, community newsletters and newspapers; presenting health talks at community senior programs; and accessing the data base and mailing invitation letters out to patients from the University Clinic.

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

Reporting Groups
  Description
Wait List Control

The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.

Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes.

Yoga Intervention

The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.

Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques.


Participant Flow for 3 periods

Period 1:   Beginning of Study: Baseline at 0 Week
    Wait List Control   Yoga Intervention
STARTED   18   18 
COMPLETED   17   18 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 

Period 2:   Mid-point of Study: 0 - 4 Weeks
    Wait List Control   Yoga Intervention
STARTED   17   18 
COMPLETED   16   18 
NOT COMPLETED   1   0 
Protocol Violation                1                0 

Period 3:   End of Study: 4 - 8 Weeks
    Wait List Control   Yoga Intervention
STARTED   16   18 
COMPLETED   16   18 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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
Wait List Control

The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.

Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes.

Yoga Intervention

The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.

Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques.

Total Total of all reporting groups

Baseline Measures
   Wait List Control   Yoga Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   18   18   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.9  (6.0)   71.9  (5.4)   71.9  (5.7) 
Gender 
[Units: Participants]
     
Female   18   18   36 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   18   18   36 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Value of OA Symptoms at 8 Weeks   [ Time Frame: 8 weeks ]

2.  Primary:   Absolute Value of OA Pain at 8 Weeks   [ Time Frame: 8 weeks ]

3.  Secondary:   Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks   [ Time Frame: 8 weeks ]

4.  Secondary:   Absolute Value of Quality of Sleep at 8 Weeks   [ Time Frame: 8 weeks ]

5.  Secondary:   Absolute Value of Quality of Life at 8 Weeks   [ Time Frame: 8 weeks ]

6.  Secondary:   Absolute Value of BMI at 8 Weeks   [ Time Frame: 8 weeks ]

7.  Other Pre-specified:   Feasibility Measures - Retention   [ Time Frame: 8 weeks ]

8.  Other Pre-specified:   Feasibility Measures - Adherence   [ Time Frame: 8 Weeks ]

9.  Other Pre-specified:   Feasibility Measure - Acceptability   [ Time Frame: 8 weeks ]

10.  Other Pre-specified:   Feasibility Measure - Safety   [ Time Frame: 8 weeks ]

11.  Other Pre-specified:   Feasibility Measure - Recruitment   [ Time Frame: 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Limitations: Small sample size without blinding. Strengths: Randomized controlled design, data collection at multiple time points and the use of a yoga expert panel to design the yoga program specifically for older women with knee osteoarthritis.


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


Results Point of Contact:  
Name/Title: Corjena Cheung, Assistant Professor
Organization: University of Minnesota
phone: 612-624-5198
e-mail: corjena@umn.edu


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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01832155     History of Changes
Other Study ID Numbers: Yoga4OA
First Submitted: April 4, 2013
First Posted: April 15, 2013
Results First Submitted: July 19, 2013
Results First Posted: March 4, 2014
Last Update Posted: April 23, 2015