The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, knee, exercise, cycling
Eligibility Criteria
Inclusion Criteria:
- symptomatic and radiographic knee OA
Exclusion Criteria:
- severe patella femoral knee pain that would make cycling difficult
- medical condition which would prohibit an exercise program
Sites / Locations
- Mercy Hospital of Pittsbugh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Exercise intervention
Control
Arm Description
Patients began the exercise intervention after randomization for 12 weeks
Patients were asked not to change their baseline exercise program
Outcomes
Primary Outcome Measures
Preferred gait speed
Secondary Outcome Measures
WOMAC
KOS
Full Information
NCT ID
NCT00917618
First Posted
June 9, 2009
Last Updated
October 13, 2017
Sponsor
Mercy Hospital, Pittsburgh, PA
Collaborators
PNC Band arthritis research fund, Mad Dogg Athletics
1. Study Identification
Unique Protocol Identification Number
NCT00917618
Brief Title
The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
Official Title
The Effects of Group Cycling (Spinning®) On Gait and Pain-Related Disability in Persons With Knee Osteoarthritis: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercy Hospital, Pittsburgh, PA
Collaborators
PNC Band arthritis research fund, Mad Dogg Athletics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, knee, exercise, cycling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Active Comparator
Arm Description
Patients began the exercise intervention after randomization for 12 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients were asked not to change their baseline exercise program
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Patients randomized to the control arm were instructed not to change their baseline exercise programs
Primary Outcome Measure Information:
Title
Preferred gait speed
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
WOMAC
Time Frame
12 weeks
Title
KOS
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic and radiographic knee OA
Exclusion Criteria:
severe patella femoral knee pain that would make cycling difficult
medical condition which would prohibit an exercise program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Krohn, MD
Organizational Affiliation
Mercy Hospital of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital of Pittsbugh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22951360
Citation
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.
Results Reference
derived
Learn more about this trial
The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
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