Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments hatha yoga, aerobic and strengthening exercises, general education
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date April 2013
End date June 2016
Trial size 96 participants
Trial identifier NCT02525341, 1212M25141

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Participants in the yoga group received a total of eight weekly 45 minute yoga classes. Handouts were provided for participants to practice the yoga program for additional 30 minutes a day, 4 days a week at home.
hatha yoga 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.
(Active Comparator)
Participants in the exercise group received a total of eight weekly 45 minute exercise classes. Handouts were provided for participants to practice the program at home for 30 minutes a day, 3 days a week (on non-consecutive days).
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)
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.
general education
One-time Arthritis Foundation educational brochures focusing on the disease process, diet and exercise and OA management education were given.

Primary Outcomes

Measure
Osteoarthritis (OA) symptoms change
time frame: Change from baseline OA symtptoms at 8 weeks
Knee OA pain change
time frame: Change from baseline pain score at 8 weeks
Knee OA pain change
time frame: Change from baseline number of medication used per day for OA pain at 8 weeks

Secondary Outcomes

Measure
Physical function
time frame: 4 and 8 weeks
Gait speed
time frame: 4 and 8 weeks
Physical activity level
time frame: 4 and 8 weeks
Fear of falling
time frame: 4 and 8 weeks
Spiritual health
time frame: 4 and 8 weeks
Quality of life
time frame: 4 and 8 weeks
Mood
time frame: 4 and 8 weeks

Eligibility Criteria

Male or female participants at least 60 years old.

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.

Additional Information

Official title Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis
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 Ninety-six community dwelling older adults ages 60 years - 100 years old with a diagnosis of symptomatic knee OA were recruited. Oversampling is planned by 20% based on average drop out in yoga intervention studies to compensate for attrition (sample of 80 participants with 16 additional participants for a total of 96). 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.