Clinical trial NCT02525341: Yoga Versus Exercises for Managing OA
Official title: Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Yoga
exercises
knee osteoarthritis
older adults
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 83
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Osteoarthritis (OA) symptoms change
timeFrame: Change from baseline OA symtptoms at 8 weeks
measure: Knee OA pain change
timeFrame: Change from baseline pain score at 8 weeks
measure: Knee OA pain change
timeFrame: Change from baseline number of medication used per day for OA pain at 8 weeks
Secondary outcomes:
measure: Physical function
timeFrame: 4 and 8 weeks
measure: Gait speed
timeFrame: 4 and 8 weeks
measure: Physical activity level
timeFrame: 4 and 8 weeks
measure: Fear of falling
timeFrame: 4 and 8 weeks
measure: Spiritual health
timeFrame: 4 and 8 weeks
measure: Quality of life
timeFrame: 4 and 8 weeks
measure: Mood
timeFrame: 4 and 8 weeks
Other outcomes:
measure: Feasibility - number of eligible subjects
timeFrame: Baseline
measure: Feasibility - exercise adherence
timeFrame: 8 weeks
measure: Feasibility - adverse events
timeFrame: 8 weeks
measure: Feasibility - retention rate
timeFrame: 8 weeks
measure: Acceptability
timeFrame: 8 weeks
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Corjena Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheung C, Wyman JF, Bronas U, McCarthy T, Rudser K, Mathiason MA. Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. Rheumatol Int. 2017 Mar;37(3):389-398. doi: 10.1007/s00296-016-3620-2. Epub 2016 Dec 2.