University of Minnesota
Minneapolis, Minnesota, 55455, United States
NCT Number: NCT02525341
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.
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Notify Me60 year–100 year
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55455, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: 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.
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.
Time frame: Change from baseline pain score at 8 weeks
Visual Analog Scale
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
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.
Time frame: 4 and 8 weeks
50 foot walk is used to measure gait speed.
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.
Time frame: 4 and 8 weeks
Fear of falling is evaluated using the Falls Efficacy Scale-International.
Time frame: 4 and 8 weeks
Self-Transcendence Scale is used to evaluate participants' spiritual health.
Time frame: 4 and 8 weeks
SF 12 v2 Health Survey is used for measuring quality of life.
Time frame: 4 and 8 weeks
Hospital Anxiety and Depression Scale is used to evaluate mood.
Time frame: Baseline
Number of eligible subjects will be assessed by the total number of subjects enrolled in the study.
Time frame: 8 weeks
Exercise adherence will be assessed base on the:
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.
Time frame: 8 weeks
Retention rate will be assessed by the number of participants remain in the study.
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.
University of Minnesota
Other
Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis
Acronym: YEMO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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