An interventional study of Hatha yoga and Aerobic and strengthening exercises in Knee Osteoarthritis, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care
The purpose of the study is to examine the short and long term effects of Hatha yoga compared to the current recommended exercise program in promoting physical function, alleviating osteoarthritis (OA)-related symptoms, fear of falling, and improving mood, spiritual health, physical activity level, and quality of life in older adults with knee OA, and to determine the effect sizes for use in power calculations to design a larger efficacy clinical trial.
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.
Study Endpoints
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 83 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
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
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
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
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.
Also known as: Yoga
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.
One-time Arthritis Foundation educational brochures focusing on the disease process, diet and exercise and OA management education were given.
Osteoarthritis (OA) symptoms change
OA pain, stiffness and function (total score) is evaluated using the Western Ontario and McMaster Universities OA (WOMAC) index scale.
Time frame: Change from baseline OA symtptoms at 8 weeks
Knee OA pain change
Visual Analog Scale
Time frame: Change from baseline pain score at 8 weeks
Knee OA pain change
Number of pain medication used per day for OA pain
Time frame: Change from baseline number of medication used per day for OA pain at 8 weeks
Physical function
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.
Time frame: 4 and 8 weeks
Gait speed
50 foot walk is used to measure gait speed.
Time frame: 4 and 8 weeks
Physical activity level
Physical Activity Scale for the Elderly is used to evaluate the different physical activity levels: leisure time activity, household activity, and work-related activity.
Time frame: 4 and 8 weeks
Fear of falling
Fear of falling is evaluated using the Falls Efficacy Scale-International.
Time frame: 4 and 8 weeks
Spiritual health
Self-Transcendence Scale is used to evaluate participants' spiritual health.
Time frame: 4 and 8 weeks
Quality of life
SF 12 v2 Health Survey is used for measuring quality of life.
Time frame: 4 and 8 weeks
Mood
Hospital Anxiety and Depression Scale is used to evaluate mood.
Time frame: 4 and 8 weeks
Feasibility - number of eligible subjects
Number of eligible subjects will be assessed by the total number of subjects enrolled in the study.
Time frame: Baseline
Feasibility - exercise adherence
Exercise adherence will be assessed base on the: 1. Average class attendance (weekly class attendance sheet recorded by the RA) 2. 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).
Time frame: 8 weeks
Feasibility - adverse events
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.
Time frame: 8 weeks
Feasibility - retention rate
Retention rate will be assessed by the number of participants remain in the study.
Time frame: 8 weeks
Acceptability
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.
Time frame: 8 weeks
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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