Yoga Versus Exercises for Managing OA

NCT02525341 | Completed DMC

• 1 other identifier: 1212M25141
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Yoga; exercises; knee osteoarthritis; older adults

Outcome Measures

Primary Outcomes (3)

• 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

• Knee OA pain change

  Visual Analog Scale

  Change from baseline pain score at 8 weeks

• 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 Outcomes (7)

• Physical function

  4 and 8 weeks

• Gait speed

  4 and 8 weeks

• Physical activity level

  4 and 8 weeks

• Fear of falling

  4 and 8 weeks

• Spiritual health

  4 and 8 weeks

Other Outcomes (5)

• Feasibility - number of eligible subjects

  Baseline

• Feasibility - exercise adherence

  8 weeks

• Feasibility - adverse events

  8 weeks

Study Arms (3)

Yoga Group

EXPERIMENTAL

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.

Other: Hatha yoga

Aerobic and Strengthening Exercise Group

ACTIVE COMPARATOR

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).

Other: Aerobic and strengthening exercises

General education

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.

Other: General education

Interventions

Hatha yoga OTHER

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.

Also known as: Yoga

Yoga Group

Aerobic and strengthening exercises OTHER

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.

Aerobic and Strengthening Exercise Group

General education OTHER

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

General education

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 27913870 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Yoga

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Corjena Cheung, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 17, 2015
• Study Start: April 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)