Yoga Versus Exercises for Managing OA (YEMO)
|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.|
|ClinicalTrials.gov Identifier: NCT02525341|
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Hatha yoga Other: Aerobic and strengthening exercises Other: General education||Not Applicable|
The specific aims of this pilot project are to:
Aim 1: Examine the short and long term effect of participation in an 8-week intervention of Hatha yoga (HY) on pain, stiffness, physical function of the lower extremities, physical activity, mood, fear of falling, spiritual health, and quality of life in older women with knee OA, compared with the effect in those older adults who participated in aerobic/strengthening exercise (AE) or received general OA education (GE).
Aim 2: Describe the adherence rate (class and home practices) and exercise acceptability of the HY and AE programs.
A randomized controlled trial design with three groups were used: 1) A Hatha yoga (HY) intervention group, 2) an aerobic and local muscle strengthening exercise (AE) control group, and 3) a general OA education (GE) true control group. Both yoga and exercise groups involved group and home practice sessions. Participants in the GE group received education on OA management after randomization. A weekly phone call were placed to them during the intervention period to reinforce OA knowledge. Data were collected from all participants at baseline, 4 weeks, and 8 weeks during the intervention, and quarterly for one year during the follow up period.
- Primary endpoint: OA status (pain, stiffness and function) at 8 weeks.
- Secondary endpoint: physical function of lower extremities, mood, and quality of life at 8 weeks.
- Tertiary endpoint: Long term exercise adherence and effects on outcome measures, program acceptability, and safety.
Sample Size and Recruitment Eight-three community dwelling older adults ages 60 years - 100 years old with a diagnosis of symptomatic knee OA were recruited. Recruitment were done through conducting presentations at various senior centers; distributing press release to various community newsletters, local and senior newspapers, and through working with my co-investigators, and accessing the data base and mailing invitation letters out to patients meeting demographic and diagnostic criteria from the University of Minnesota Physician Practice.
Each weekly group based session is 45 minute in length for all groups. Participants in the yoga group were recommended to practice for additional 30 minutes four times a week at home. Participants in the A/E class were recommended to practice 3 times on non-consecutive days at home as recommended by the current physical activity guidelines for older adults. To assist participants with maintaining exercise adherence and practicing yoga and aerobic/strengthening exercises at home correctly, handouts illustrating yoga/exercise activity were distributed at the end of each class. Participants also were asked to videotape and keep a log of their exercise practice during the intervention period. Video camera were provided. Long term exercise adherence was assessing using an exercise diary. Participants were asked to keep an exercise diary during the follow up period. A focus group will be conducted at the end of the follow-up period to examine the experience of using HY or AE for managing knee OA, and factors that affect participants' HY/AE adherence.
Descriptive statistics will be used to analyze and report demographic data and feasibility/acceptability data. Inferential statistics (t-test or non-parametric equivalent such as Mann-Whitney, and chi-square test) will be used to analyze the OA symptoms, physical and psychological outcomes. The α level will be set at ≤ .05.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Yoga Group
Participants in the yoga group received a total of eight weekly 45 minute yoga classes. A sequence of 8 - 10 core yoga poses, breathing and relaxation techniques were practiced in each yoga class, and 2 - 3 new poses were introduced progressively in each of the yoga session. Props such as blocks, blankets, belts, mats, and chairs were used during the session. Handouts were provided for participants to practice the yoga program for additional 30 minutes a day, 4 days a week at home.
Other: Hatha yoga
A sequence of 8 - 10 core yoga poses, breathing and relaxation techniques were practiced in each yoga class, and 2 - 3 new poses were introduced progressively in each of the yoga session. Props such as blocks, blankets, belts, mats, and chairs were used during the session.
Other Name: Yoga
Active Comparator: Aerobic and Strengthening Exercise Group
Participants in the exercise group received a total of eight weekly 45 minute exercise classes. A 15 minute of gentle aerobic exercise and a 30 minute of strengthening program that includes both isometric (without moving the joints) and isotonic (moving the joints) exercises of the lower extremities were taught to the participants. Handouts were provided for participants to practice the program at home for 30 minutes a day, 3 days a week (on non-consecutive days).
Other: Aerobic and strengthening exercises
A 15 minute of gentle aerobic exercise and a 30 minute of strengthening program that includes both isometric (without moving the joints) and isotonic (moving the joints) exercises of the lower extremities were taught to the participants.
Active Comparator: General education
Participants in this group received a one-time OA educational brochures from the Arthritis Foundation including topics focusing on the disease process, diet and exercise and OA management education. Participants were instructed not to begin any new exercise programs during the study period.
Other: General education
One-time Arthritis Foundation educational brochures focusing on the disease process, diet and exercise and OA management education were given.
- Osteoarthritis (OA) symptoms change [ Time Frame: Change from baseline OA symtptoms at 8 weeks ]OA pain, stiffness and function (total score) is evaluated using the Western Ontario and McMaster Universities OA (WOMAC) index scale.
- Knee OA pain change [ Time Frame: Change from baseline pain score at 8 weeks ]Visual Analog Scale
- Knee OA pain change [ Time Frame: Change from baseline number of medication used per day for OA pain at 8 weeks ]Number of pain medication used per day for OA pain
- Physical function [ Time Frame: 4 and 8 weeks ]The Short Physical Performance Battery, which includes repeated chair stands, balance and 8 foot walk tests, is used to evaluate participants' physical function of lower extremities.
- Gait speed [ Time Frame: 4 and 8 weeks ]50 foot walk is used to measure gait speed.
- Physical activity level [ Time Frame: 4 and 8 weeks ]Physical Activity Scale for the Elderly is used to evaluate the different physical activity levels: leisure time activity, household activity, and work-related activity.
- Fear of falling [ Time Frame: 4 and 8 weeks ]Fear of falling is evaluated using the Falls Efficacy Scale-International.
- Spiritual health [ Time Frame: 4 and 8 weeks ]Self-Transcendence Scale is used to evaluate participants' spiritual health.
- Quality of life [ Time Frame: 4 and 8 weeks ]SF 12 v2 Health Survey is used for measuring quality of life.
- Mood [ Time Frame: 4 and 8 weeks ]Hospital Anxiety and Depression Scale is used to evaluate mood.
- Feasibility - number of eligible subjects [ Time Frame: Baseline ]Number of eligible subjects will be assessed by the total number of subjects enrolled in the study.
- Feasibility - exercise adherence [ Time Frame: 8 weeks ]
Exercise adherence will be assessed base on the:
- Average class attendance (weekly class attendance sheet recorded by the RA)
- Frequency of home practice: the average number of days per week, and the average number of minutes per day (participants' weekly self-report on an exercise log sheet).
- Feasibility - adverse events [ Time Frame: 8 weeks ]RA will record any number or type of yoga related adverse events during the intervention classes. Participants will record any number or type of yoga related adverse events during their home practice on the exercise log sheet.
- Feasibility - retention rate [ Time Frame: 8 weeks ]Retention rate will be assessed by the number of participants remain in the study.
- Acceptability [ Time Frame: 8 weeks ]An investigator-developed survey using a 10 point Likert scale will be used to assess participants' self-report satisfaction with the intervention program, perceived appropriateness of the program, and intention to continue to use the intervention program.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525341
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Corjena Cheung, PhD||University of Minnesota - Clinical and Translational Science Institute|