Knee OsteoarthritisNCT00917618
The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
A study testing Exercise in people with Knee Osteoarthritis, run by Mercy Hospital, Pittsburgh, PA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic and radiographic knee OA
Who cannot join
- severe patella femoral knee pain that would make cycling difficult
- medical condition which would prohibit an exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy Hospital of Pittsbugh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: The Effects of Group Cycling (Spinning®) On Gait and Pain-Related Disability in Persons With Knee Osteoarthritis: A Randomized Control Trial
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise, Control
- Keywords
- osteoarthritis, knee, exercise, cycling
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.
ControlOther
Patients randomized to the control arm were instructed not to change their baseline exercise programs
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Active comparator | Patients began the exercise intervention after randomization for 12 weeks Receives: Other: Exercise |
| Control | Placebo comparator | Patients were asked not to change their baseline exercise program Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred gait speed
Measured: 12 weeks
Secondary outcomes (2)
WOMAC
Measured: 12 weeks
KOS
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJan 2005
- Primary completionMay 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Hospital, Pittsburgh, PA
- Sponsor type
- University, hospital or other
- Collaborators
- PNC Band arthritis research fund, Mad Dogg Athletics
- Responsible party
- Sponsor
- Investigators
- Kelly Krohn, MD, Principal investigator, Mercy Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917618
- Sponsor's protocol ID
- 0001
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22951360
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Group Cycling (Spinning®) On Gait and Pain-Related Disability in Persons With Knee Osteoarthritis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00917618
- Acronym / sponsor ID
- 0001
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, knee, exercise, cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mercy Hospital, Pittsburgh, PAUniversity, hospital or other
- Collaborators
- PNC Band arthritis research fund, Mad Dogg Athletics
- Study start
- Jan 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Active comparator | Other: ExercisePatients began the exercise intervention after randomization for 12 weeks |
| Control | Placebo comparator | Other: ControlPatients were asked not to change their baseline exercise program |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic and radiographic knee OA
Key exclusion criteria (2 listed)
- severe patella femoral knee pain that would make cycling difficult
- medical condition which would prohibit an exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePatients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks. | Other | Exercise intervention |
| ControlPatients randomized to the control arm were instructed not to change their baseline exercise programs | Other | Control |
Primary outcome
Preferred gait speed
Time frame: 12 weeks
2 secondary outcomes
WOMAC
Time frame: 12 weeks
KOS
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Derived from this study: PubMed 22951360Salacinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Krohn, MD principal investigator
Mercy Hospital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Knee Osteoarthritis, run by Mercy Hospital, Pittsburgh, PA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferred gait speed (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.