NCT01832155

Brief Summary

The study hypothesized that it is feasible and safe to use Hatha yoga in older women with knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and stiffness, enhance physical function, and improve quality of sleep and quality of life in older women with knee OA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 4, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

April 4, 2013

Results QC Date

July 19, 2013

Last Update Submit

October 30, 2019

Conditions

Keywords

YogaKnee osteoarthritisSymptom managementOlder womenPainStiffnessPhysical function)Physical function of the lower extremitiesQuality of sleepQuality of life

Outcome Measures

Primary Outcomes (2)

  • Absolute Value of OA Symptoms at 8 Weeks

    Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    8 weeks

  • Absolute Value of OA Pain at 8 Weeks

    A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.

    8 weeks

Secondary Outcomes (4)

  • Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks

    8 weeks

  • Absolute Value of Quality of Sleep at 8 Weeks

    8 weeks

  • Absolute Value of Quality of Life at 8 Weeks

    8 weeks

  • Absolute Value of BMI at 8 Weeks

    8 weeks

Other Outcomes (5)

  • Feasibility Measures - Retention

    8 weeks

  • Feasibility Measures - Adherence

    8 Weeks

  • Feasibility Measure - Acceptability

    8 weeks

  • +2 more other outcomes

Study Arms (2)

yoga intervention

EXPERIMENTAL

The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.

Behavioral: Hatha yoga

wait list control

OTHER

The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.

Behavioral: Hatha Yoga

Interventions

Hatha YogaBEHAVIORAL

Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques.

yoga intervention

Eligibility Criteria

Age65 Years - 86 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • community-dwelling women aged 65 years or over
  • had a symptomatic OA of knee diagnosis for at least 6 months
  • had no previous training in any form of yoga; and
  • were not currently participating in a supervised exercise program
  • cognitively intact

You may not qualify if:

  • symptoms of joint locking;
  • instability indicated by chronic use of a knee brace, cane, walker, or wheelchair;
  • a corticosteroid injection in the symptomatic joint within three months of study entry;
  • a hyaluronic acid injection in the symptomatic joint within six months of study entry;
  • a history of knee surgery within the last two years or a joint replacement at any point;
  • individuals who had self-reported significant medical comorbidities that might preclude exercise participation such as: a) uncontrolled high blood pressure or existing heart condition; and b) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis) were also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Cheung C, Wyman JF, Resnick B, Savik K. Yoga for managing knee osteoarthritis in older women: a pilot randomized controlled trial. BMC Complement Altern Med. 2014 May 18;14:160. doi: 10.1186/1472-6882-14-160.

MeSH Terms

Conditions

Osteoarthritis, KneePainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Limitations and Caveats

Limitations: Small sample size without blinding. Strengths: Randomized controlled design, data collection at multiple time points and the use of a yoga expert panel to design the yoga program specifically for older women with knee osteoarthritis.

Results Point of Contact

Title
Corjena Cheung, Assistant Professor
Organization
University of Minnesota

Study Officials

  • Corjena K Cheung, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 15, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 1, 2019

Results First Posted

March 4, 2014

Record last verified: 2019-10

Locations