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Yoga Versus Exercises for Managing OA (YEMO)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hatha yoga
Aerobic and strengthening exercises
General education
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Yoga, exercises, knee osteoarthritis, older adults

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Yoga Group

Aerobic and Strengthening Exercise Group

General education

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Osteoarthritis (OA) symptoms change
OA pain, stiffness and function (total score) is evaluated using the Western Ontario and McMaster Universities OA (WOMAC) index scale.
Knee OA pain change
Visual Analog Scale
Knee OA pain change
Number of pain medication used per day for OA pain

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2015
Last Updated
May 3, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02525341
Brief Title
Yoga Versus Exercises for Managing OA
Acronym
YEMO
Official Title
Yoga Versus Aerobic and Strengthening Exercises for Managing Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Primary endpoint: OA status (pain, stiffness and function) at 8 weeks. Secondary endpoint: physical function of lower extremities, mood, and quality of life at 8 weeks. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Yoga, exercises, knee osteoarthritis, older adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic and Strengthening Exercise Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
General education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hatha yoga
Other Intervention Name(s)
Yoga
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic and strengthening exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General education
Intervention Description
One-time Arthritis Foundation educational brochures focusing on the disease process, diet and exercise and OA management education were given.
Primary Outcome Measure Information:
Title
Osteoarthritis (OA) symptoms change
Description
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 OA symtptoms at 8 weeks
Title
Knee OA pain change
Description
Visual Analog Scale
Time Frame
Change from baseline pain score at 8 weeks
Title
Knee OA pain change
Description
Number of pain medication used per day for OA pain
Time Frame
Change from baseline number of medication used per day for OA pain at 8 weeks
Secondary Outcome Measure Information:
Title
Physical function
Description
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
Title
Gait speed
Description
50 foot walk is used to measure gait speed.
Time Frame
4 and 8 weeks
Title
Physical activity level
Description
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
Title
Fear of falling
Description
Fear of falling is evaluated using the Falls Efficacy Scale-International.
Time Frame
4 and 8 weeks
Title
Spiritual health
Description
Self-Transcendence Scale is used to evaluate participants' spiritual health.
Time Frame
4 and 8 weeks
Title
Quality of life
Description
SF 12 v2 Health Survey is used for measuring quality of life.
Time Frame
4 and 8 weeks
Title
Mood
Description
Hospital Anxiety and Depression Scale is used to evaluate mood.
Time Frame
4 and 8 weeks
Other Pre-specified Outcome Measures:
Title
Feasibility - number of eligible subjects
Description
Number of eligible subjects will be assessed by the total number of subjects enrolled in the study.
Time Frame
Baseline
Title
Feasibility - exercise adherence
Description
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).
Time Frame
8 weeks
Title
Feasibility - adverse events
Description
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
Title
Feasibility - retention rate
Description
Retention rate will be assessed by the number of participants remain in the study.
Time Frame
8 weeks
Title
Acceptability
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corjena Cheung, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27913870
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.
Results Reference
derived

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Yoga Versus Exercises for Managing OA

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