NCT02146105

Brief Summary

Keeping individuals with knee osteoarthritis physically active is critically important. Exercise is effective at reducing pain while improving physical function. However some exercises can overload the knee, and as a result, worsen knee pain and health of the knee joint. Yoga offers a foundation of static postures that improve muscle strength and joint flexibility. Using sophisticated technology that allows us to calculate the loads inside the knee, the investigators have selected yoga exercises that do not overload the knee joint. The investigators have designed a yoga exercise class that is ideal for people with knee osteoarthritis. The purpose of the study is to investigate whether these yoga exercises increase muscle strength and reduce knee pain in women with knee osteoarthritis. In addition, the investigators aim to show that these yoga exercises will also improve knee loads during activities, mobility and heart health. The investigators will ask 50 women with knee osteoarthritis to participate in a 12 week yoga exercise intervention, that requires attendance to 3 classes each week. The investigators will test strength of the leg muscles, pain, knee joint loads, mobility and cardiovascular health before and after the 12 week yoga exercise intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

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

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
18 days until next milestone

Results Posted

Study results publicly available

February 19, 2015

Completed
Last Updated

September 26, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

May 16, 2014

Results QC Date

February 3, 2015

Last Update Submit

August 28, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Knee Extensor Torque

    Knee extensor torque (Newton\*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.

    Week 1 and Week 13

  • Change in Knee Pain

    Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.

    Week 1 and Week 13

Secondary Outcomes (7)

  • Change in Six Minute Walk Test (6MWT)

    Week 1 and Week 13

  • Change in 30-second Chair Stand

    Week 1 and Week 13

  • Change in Timed Up and Go (TUG)

    Week 1 and Week 13

  • Change in Stair Ascent and Descent

    Week 1 and Week 13

  • Change in Subjective Scales

    Week 1 and Week 13

  • +2 more secondary outcomes

Study Arms (1)

Yoga For Knee Osteoarthritis

EXPERIMENTAL

An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.

Other: Yoga For Knee Osteoarthritis

Interventions

Yoga program specifically for women with knee osteoarthritis.

Yoga For Knee Osteoarthritis

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female - 50 years of age or older
  • Knee pain on most days of the week
  • Less than 30 minutes of morning stiffness
  • Bony enlargement
  • Bony tenderness to palpation
  • Signs of inflammation
  • Able to safely climb 2 flights of stairs without aid
  • Visited a family physician within the last 12 months

You may not qualify if:

  • Any other forms of arthritis
  • Osteoporosis
  • History of patellofemoral symptoms
  • Active non-arthritic knee disease
  • Knee surgery
  • Use of cane or walking aid
  • Unstable heart condition
  • Neurological conditions
  • Skin allergy to medical tape
  • Hip or ankle injuries in past 3 months
  • Any injuries that would prohibit participation in yoga
  • Ipsilateral hip or ankle conditions
  • Currently receiving cancer treatment
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P 3Y4, Canada

Location

Related Publications (1)

  • Brenneman EC, Kuntz AB, Wiebenga EG, Maly MR. A Yoga Strengthening Program Designed to Minimize the Knee Adduction Moment for Women with Knee Osteoarthritis: A Proof-Of-Principle Cohort Study. PLoS One. 2015 Sep 14;10(9):e0136854. doi: 10.1371/journal.pone.0136854. eCollection 2015.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Yoga

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Results Point of Contact

Title
Dr. Monica Maly
Organization
McMaster University

Study Officials

  • Monica R Maly, PhD

    School of Rehabilitation Sciences, McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 23, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 26, 2017

Results First Posted

February 19, 2015

Record last verified: 2017-08

Locations