Yoga Versus Exercises for Managing OA

Knee Osteoarthritis Clinical Trial

— YEMO  

Official title:

Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525341
• Other study ID #: 1212M25141
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: July 2016

Study information

• Verified date: May 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. Primary endpoint: OA status (pain, stiffness and function) at 8 weeks.

2. Secondary endpoint: physical function of lower extremities, mood, and quality of life at 8 weeks.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• have been diagnosed with symptomatic OA of knee for at least 6 months,

• have not practiced any form of yoga for at least 2 months; and

• not currently participating in a supervised exercise program. "Currently" is defined as not participating in a supervised exercise program more than 2 times a week at the time of second-step screening.

Exclusion Criteria:

• OA is asymptomatic,

• have moderate/severe cognitive impairment, scored less than 8 on the Short Portable Mental Status Questionnaire,

• have cardiovascular risk,

• reported symptoms of joint locking,

• instability indicated by chronic use of a knee brace, cane, walker, or wheelchair,

• corticosteroid injection in the symptomatic joint within 3 months of study entry,

• hyaluronic acid injection: hyaluronan (Hyalgan) and synthetic hylan G-F 20 (Synvisc) in the symptomatic joint within 6 months of study entry,

• history of knee surgery within the last two years, arthroscopic lavage within 6 months, or a joint replacement of the lower extremities at any point,

• self-reported significant medical comorbidities such as: 1) uncontrolled high blood pressure or existing heart condition; and 2) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis),

• Individuals who have medication changes for arthritis symptoms will be permitted to remain in the trial; however, these changes will be monitored.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.
• General education
One-time Arthritis Foundation educational brochures focusing on the disease process, diet and exercise and OA management education were given.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility - number of eligible subjects	Number of eligible subjects will be assessed by the total number of subjects enrolled in the study.	Baseline
Other	Feasibility - exercise adherence	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).	8 weeks
Other	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.	8 weeks
Other	Feasibility - retention rate	Retention rate will be assessed by the number of participants remain in the study.	8 weeks
Other	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.	8 weeks
Primary	Osteoarthritis (OA) symptoms change	OA pain, stiffness and function (total score) is evaluated using the Western Ontario and McMaster Universities OA (WOMAC) index scale.	Change from baseline OA symtptoms at 8 weeks
Primary	Knee OA pain change	Visual Analog Scale	Change from baseline pain score at 8 weeks
Primary	Knee OA pain change	Number of pain medication used per day for OA pain	Change from baseline number of medication used per day for OA pain at 8 weeks
Secondary	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.	4 and 8 weeks
Secondary	Gait speed	50 foot walk is used to measure gait speed.	4 and 8 weeks
Secondary	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.	4 and 8 weeks
Secondary	Fear of falling	Fear of falling is evaluated using the Falls Efficacy Scale-International.	4 and 8 weeks
Secondary	Spiritual health	Self-Transcendence Scale is used to evaluate participants' spiritual health.	4 and 8 weeks
Secondary	Quality of life	SF 12 v2 Health Survey is used for measuring quality of life.	4 and 8 weeks
Secondary	Mood	Hospital Anxiety and Depression Scale is used to evaluate mood.	4 and 8 weeks