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Trial record 15 of 16 for:    +yoga+arthritis

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

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ClinicalTrials.gov Identifier: NCT01832155
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : March 4, 2014
Last Update Posted : April 23, 2015
Sponsor:
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

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
Enrollment 36
Recruitment Details 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 No significant events and approaches for the overall study following participant enrollment/prior to group assignment.
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description

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.

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.

Period Title: Beginning of Study: Baseline at 0 Week
Started 18 18
Completed 17 18
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Mid-point of Study: 0 - 4 Weeks
Started 17 18
Completed 16 18
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Period Title: End of Study: 4 - 8 Weeks
Started 16 18
Completed 16 18
Not Completed 0 0
Arm/Group Title Wait List Control Yoga Intervention Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
18
 100.0%
18
 100.0%
36
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
71.9  (6.0) 71.9  (5.4) 71.9  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
18
 100.0%
18
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Absolute Value of OA Symptoms at 8 Weeks
Hide Description Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: units on a scale
39.3  (3.0) 31.0  (3.0)
2.Primary Outcome
Title Absolute Value of OA Pain at 8 Weeks
Hide Description A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Control Group Yoga Intervention Group
Hide Arm/Group Description:
Participants in the control group received the same Hatha yoga program at the end of 8 weeks when the intervention group completed their intervention classes.

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.

Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: Number of pain medication/day
1  (1.4) 1  (1.3)
3.Secondary Outcome
Title Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks
Hide Description Secondary outcome measures included physical performance of the LE which was assessed using the Short Physical Performance Battery (SPPB) developed by the National Institute on Aging. The test consists of three components: repeated chair stands (4 points), balance (4 points), and timed 8" walk (4 points). A maximum score of 12 points can be achieved. Higher values indicate better physical functions.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: units on a scale
9.0  (.37) 10.0  (.37)
4.Secondary Outcome
Title Absolute Value of Quality of Sleep at 8 Weeks
Hide Description Pittsburgh Sleep Quality Index (PSQI) was used to measure quality of sleep. The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0–3 whereby 3 reflects the negative extreme on the Likert Scale. The 7 component scores are added to obtain a global score ranging from 0–21, with higher scores indicating worse sleep quality. A global score of ≥ 5 on the PSQI total scale, which is computed as a sum of the seven subscales (e.g., sleep quality, sleep latency, sleep duration, sleep disturbance, sleep efficiency, and use sleep medication) is associated with clinically significant sleep disruptions, including insomnia and major mood disorders.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: units on a scale
6.1  (.52) 5.0  (.52)
5.Secondary Outcome
Title Absolute Value of Quality of Life at 8 Weeks
Hide Description The self-perceived quality of life was assessed using the Short Form Health Survey (SF-12) which measures a total of 8 health domains: 4 physical and 4 mental component summary scales. Physical Health (physical functioning, role-physical, bodily pain, and general health)and Mental Health (vitality, social functioning, role-emotional, and mental health) Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The Cantril Self-Anchoring Ladder that measures both "current" and "in 5 years" using steps from 0 to 10, where "0" represents the worst possible life and "10" represents the best possible life.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: units on a scale
SF12 MCS 51.7  (1.2) 49.7  (1.2)
SF12 PCS 38.7  (1.0) 38.0  (.98)
Cantril Ladder current 7.7  (.37) 7.5  (.37)
Cantril Ladder in 5 years 7.8  (.32) 7.2  (.32)
6.Secondary Outcome
Title Absolute Value of BMI at 8 Weeks
Hide Description BMI was calculated using the participant's weight and height, kg/m^2.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: kg/m^2
28.9  (.16) 28.7  (.16)
7.Other Pre-specified Outcome
Title Feasibility Measures - Retention
Hide Description Feasibility was measured by the retention rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Participants' class attendance (average number of classes attended) was evaluated.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Class Rentention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Mean (Full Range)
Unit of Measure: classes
6
(1 to 8)
8.Other Pre-specified Outcome
Title Feasibility Measures - Adherence
Hide Description Feasibility was also measured by the home practice adherence rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Home yoga practice adherence was determined by participants' report of the average number of minutes of yoga practiced at home.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 33
Mean (Full Range)
Unit of Measure: minutes/week
112
(21 to 190)
9.Other Pre-specified Outcome
Title Feasibility Measure - Acceptability
Hide Description Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment. Upon completion of the yoga program, perceived level of program difficulty was rated by participants using a scale of 1 - 10 where 10 represents "extremely difficult" and a scale of 1 - 10 where 10 represents "most enjoyable" was used to measure perceived level of program enjoyment. Data from both intervention and wait-list control (during the intervention period) groups were collected.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title About the Yoga Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Mean (Full Range)
Unit of Measure: units on a scale
Level of difficulty
4
(0 to 9)
level of enjoyment
9
(5 to 10)
10.Other Pre-specified Outcome
Title Feasibility Measure - Safety
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Both Groups During Yoga Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: injuries
Number of yoga related injuries in class 0
Number of yoga home practice related injuries 0
11.Other Pre-specified Outcome
Title Feasibility Measure - Recruitment
Hide Description The number of months it took to recruit 36 participants.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: months
9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wait List Control Yoga Intervention
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Wait List Control Yoga Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Wait List Control Yoga Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wait List Control Yoga Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
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.
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
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