Yoga Versus Exercises for Managing OA

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Hatha yoga; Other: Aerobic and strengthening exercises; Other: General education

• Registration Number: NCT02525341
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga Group	Hatha yoga	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.
Aerobic and Strengthening Exercise Group	Aerobic and strengthening exercises	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).
General education	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.

Primary Outcome Measures

Name	Time	Method
Osteoarthritis (OA) symptoms change	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	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

Secondary Outcome Measures

Name	Time	Method
Gait speed	4 and 8 weeks	50 foot walk is used to measure gait speed.
Physical activity level	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.
Spiritual health	4 and 8 weeks	Self-Transcendence Scale is used to evaluate participants' spiritual health.
Quality of life	4 and 8 weeks	SF 12 v2 Health Survey is used for measuring quality of life.
Mood	4 and 8 weeks	Hospital Anxiety and Depression Scale is used to evaluate mood.
Fear of falling	4 and 8 weeks	Fear of falling is evaluated using the Falls Efficacy Scale-International.
Physical function	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States