NCT00917618

Brief Summary

Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3 per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable knee-osteoarthritis

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, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

October 17, 2017

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

June 9, 2009

Last Update Submit

October 13, 2017

Conditions

Knee Osteoarthritis

Keywords

osteoarthritiskneeexercisecycling

Outcome Measures

Primary Outcomes (1)

  • Preferred gait speed

    12 weeks

Secondary Outcomes (2)

  • WOMAC

    12 weeks

  • KOS

    12 weeks

Study Arms (2)

Exercise intervention

ACTIVE COMPARATOR

Patients began the exercise intervention after randomization for 12 weeks

Other: Exercise

Control

PLACEBO COMPARATOR

Patients were asked not to change their baseline exercise program

Other: Control

Interventions

ExerciseOTHER

Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.

Exercise intervention
ControlOTHER

Patients randomized to the control arm were instructed not to change their baseline exercise programs

Control

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic and radiographic knee OA

You may not qualify if:

  • severe patella femoral knee pain that would make cycling difficult
  • medical condition which would prohibit an exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Hospital of Pittsbugh

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (1)

  • Salacinski AJ, Krohn K, Lewis SF, Holland ML, Ireland K, Marchetti G. The effects of group cycling on gait and pain-related disability in individuals with mild-to-moderate knee osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Dec;42(12):985-95. doi: 10.2519/jospt.2012.3813. Epub 2012 Aug 2.

    PMID: 22951360DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kelly Krohn, MD

    Mercy Hospital of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

January 1, 2005

Primary Completion

May 1, 2006

Study Completion

September 1, 2006

Last Updated

October 17, 2017

Record last verified: 2009-06

Locations

US(1)