Osteoarthritis, KneeNCT01359124
Reaching Exercise Goals: Comparison of Exercise Means in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The primary objective is to evaluate water based treadmill exercise, land based treadmill exercise, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Exercise Cycle, Land-based Treadmill and Water-based Treadmill
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2012
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects for this study will be recruited from Penn State Milton S. Hershey Medical Center and surrounding communities via internal and external advertisements.
Who may be able to join
- Ages 30-60
- Knee pain
- Radiographically confirmed knee osteoarthritis
Who cannot join
- Medical conditions contraindicating moderate aerobic exercise as determined through prescreening questions, ie: heart condition, asthma, history of stroke.
- Inability to exercise via treadmill or exercise cycle
- Contraindication to radiography
- Pregnancy
- History of recent joint injection (steroid, synvisc, etc.) within 6 weeks of study
- History of previous joint arthroplasty
- History of inflammatory joint disease
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Reaching Exercise Goals: Comparison of the Underwater Treadmill, Land Based Treadmill, and Exercise Cycle in Patients With Knee Osteoarthritis
The primary objective is to evaluate water based treadmill exercise, land based treadmill exercise, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise.
The secondary objective is to compare exercise tolerance for water based treadmill, land based treadmill, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise.
The tertiary objective is to evaluate quality of life improvements for water based treadmill exercise, land based treadmill exercise, and upright cycling.
Read the detailed description
Osteoarthritis is the most common joint disorder in the United States, affecting approximately 26.9 million adults greater than 25 years of age. This disorder can be very debilitating: more than 40% of adults with doctor diagnosed arthritis have reported that joint symptoms cause them to modify their activities. Risk of disability (defined as needing help walking or climbing stairs) associated with osteoarthritis is considered equivalent to cardiovascular disease and is greater than any other medical condition in elderly patients [13]. Persons with disability associated with osteoarthritis have a substantially worse health-related quality of life, in large part due to their inability to exercise.
Exercise has been shown to help maintain function in knee osteoarthritis [5]. Aerobic walking and quadriceps strengthening exercises ([18];[7]) and resistance training [15] have demonstrated that exercise can potentially improve pain and function in individuals with knee osteoarthritis. Likewise, a Cochrane review on aquatic exercise provided gold level evidence that aquatic exercise probably reduces pain and increases function over 3 months; but, it stated clearly that more research was needed to understand which type of aquatic exercise, how often, and for how long might be beneficial [2]. The American College of Sports Medicine (ACSM) recommendations for healthy adults recommend moderate-intensity aerobic exercise (endurance) physical activity for a minimum of 30 minutes, 5 days per week or vigorous-intensity aerobic physical activity for a minimum of 20 minutes, 3 days per week in all healthy adults aged 18 to 65 to promote and maintain health [9]. The best method of reaching current ACSM goals in patients with knee osteoarthritis is not known, as impact-related exercise certainly demands healthy joints and many patients with knee osteoarthritis do not tolerate this form of exercise.
In counseling patients with knee osteoarthritis, the question remains: how best to exercise to reach the ACSM goals for exercise. This study will compare water-based and land-based treadmill exercise and upright cycling in meeting ACSM exercise goals for moderate exercise.
Interested subjects will undergo knee radiographs to confirm presence and degree of knee osteoarthritis. Eligible participants will then be randomized into one of the three exercise cohorts. During each session, participants will complete between 10 to 45 minutes of exercise, with a goal of achieving 30 minutes of moderate aerobic exercise. All subjects will only participate in routine activities for the 8 week study period outside of the study protocol (no strength training, cardio training, etc.). Health status measurement questionnaires (WOMAC, KOOS, and SF12) will be completed at the time of randomization and at the conclusion of each week of exercise for a total of 9 times.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Exercise Cycle, Land-based Treadmill, Water-based Treadmill
- Keywords
- Osteoarthritis, Knee, Exercise Therapies
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CycleBehavioural
Also called Schwinn Windsprint Exercise Cycle
Exercise regimen: three monitored exercise sessions per week for eight weeks using the upright exercise cycle.
Land-based TreadmillBehavioural
Also called True CS 6.0 treadmill, Nautilus NTR 700 treadmill
Exercise regimen: three monitored exercise sessions per week for eight weeks using the land-based treadmill.
Water-based TreadmillBehavioural
Also called Hydroworx 2000 Series pool treadmill
Exercise regimen: three monitored exercise sessions per week for eight weeks using the water-based treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Water Treadmill | These subjects will participate in three monitored exercise sessions per week for 8 weeks using a water-based treadmill. Receives: Behavioral: Water-based Treadmill | |
| Land Treadmill | These subjects will participate in three monitored exercise sessions per week for 8 weeks using a land-based treadmill. Receives: Behavioral: Land-based Treadmill | |
| Exercise Cycle | These subjects will participate in three monitored exercise sessions per week for 8 weeks using an upright exercise cycle. Receives: Behavioral: Exercise Cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
Exercise tolerance will be assessed based upon changes in symptoms related to knee osteoarthritis and exercise limitations related to those symptoms.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Armstrong, Milton S. Hershey Medical Center
- Investigators
- Matthew Silvis, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359124
- Sponsor's protocol ID
- IRB#35938
- Status last verified
- Feb 2015
- First submitted
- 20 May 2011
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.
PubMed 10993420Bartels EM, Lund H, Hagen KB, Dagfinrud H, Christensen R, Danneskiold-Samsoe B. Aquatic exercise for the treatment of knee and hip osteoarthritis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005523. doi: 10.1002/14651858.CD005523.pub2.
PubMed 17943863Bosomworth NJ. Exercise and knee osteoarthritis: benefit or hazard? Can Fam Physician. 2009 Sep;55(9):871-8.
PubMed 19752252Cottrell E, Roddy E, Foster NE. The attitudes, beliefs and behaviours of GPs regarding exercise for chronic knee pain: a systematic review. BMC Fam Pract. 2010 Jan 18;11:4. doi: 10.1186/1471-2296-11-4.
PubMed 20082694Dunlop DD, Semanik P, Song J, Sharma L, Nevitt M, Jackson R, Mysiw J, Chang RW; Osteoarthritis Initiative Investigators. Moving to maintain function in knee osteoarthritis: evidence from the osteoarthritis initiative. Arch Phys Med Rehabil. 2010 May;91(5):714-21. doi: 10.1016/j.apmr.2010.01.015.
PubMed 20434608Dunn AL, Jewell JS. The effect of exercise on mental health. Curr Sports Med Rep. 2010 Jul-Aug;9(4):202-7. doi: 10.1249/JSR.0b013e3181e7d9af.
PubMed 20622537Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31.
PubMed 8980206Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
PubMed 18843657Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
PubMed 17762377Heckman GA, McKelvie RS. Cardiovascular aging and exercise in healthy older adults. Clin J Sport Med. 2008 Nov;18(6):479-85. doi: 10.1097/JSM.0b013e3181865f03.
PubMed 19001881Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177.
PubMed 18163481KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PubMed 13498604Hunter DJ, McDougall JJ, Keefe FJ. The symptoms of osteoarthritis and the genesis of pain. Rheum Dis Clin North Am. 2008 Aug;34(3):623-43. doi: 10.1016/j.rdc.2008.05.004.
PubMed 18687276Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009 Dec;60(12):3546-53. doi: 10.1002/art.24984.
PubMed 19950287Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
PubMed 18821647
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Exercise Goals: Comparison of the Underwater Treadmill, Land Based Treadmill, and Exercise Cycle in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01359124
- Acronym / sponsor ID
- IRB#35938
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Exercise Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 May 2011 (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.
The primary objective is to evaluate water based treadmill exercise, land based treadmill exercise, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise.
The secondary objective is to compare exercise tolerance for water based treadmill, land based treadmill, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise.
The tertiary objective is to evaluate quality of life improvements for water based treadmill exercise, land based treadmill exercise, and upright cycling.
Detailed description
Osteoarthritis is the most common joint disorder in the United States, affecting approximately 26.9 million adults greater than 25 years of age. This disorder can be very debilitating: more than 40% of adults with doctor diagnosed arthritis have reported that joint symptoms cause them to modify their activities. Risk of disability (defined as needing help walking or climbing stairs) associated with osteoarthritis is considered equivalent to cardiovascular disease and is greater than any other medical condition in elderly patients [13]. Persons with disability associated with osteoarthritis have a substantially worse health-related quality of life, in large part due to their inability to exercise.
Exercise has been shown to help maintain function in knee osteoarthritis [5]. Aerobic walking and quadriceps strengthening exercises ([18];[7]) and resistance training [15] have demonstrated that exercise can potentially improve pain and function in individuals with knee osteoarthritis. Likewise, a Cochrane review on aquatic exercise provided gold level evidence that aquatic exercise probably reduces pain and increases function over 3 months; but, it stated clearly that more research was needed to understand which type of aquatic exercise, how often, and for how long might be beneficial [2]. The American College of Sports Medicine (ACSM) recommendations for healthy adults recommend moderate-intensity aerobic exercise (endurance) physical activity for a minimum of 30 minutes, 5 days per week or vigorous-intensity aerobic physical activity for a minimum of 20 minutes, 3 days per week in all healthy adults aged 18 to 65 to promote and maintain health [9]. The best method of reaching current ACSM goals in patients with knee osteoarthritis is not known, as impact-related exercise certainly demands healthy joints and many patients with knee osteoarthritis do not tolerate this form of exercise.
In counseling patients with knee osteoarthritis, the question remains: how best to exercise to reach the ACSM goals for exercise. This study will compare water-based and land-based treadmill exercise and upright cycling in meeting ACSM exercise goals for moderate exercise.
Interested subjects will undergo knee radiographs to confirm presence and degree of knee osteoarthritis. Eligible participants will then be randomized into one of the three exercise cohorts. During each session, participants will complete between 10 to 45 minutes of exercise, with a goal of achieving 30 minutes of moderate aerobic exercise. All subjects will only participate in routine activities for the 8 week study period outside of the study protocol (no strength training, cardio training, etc.). Health status measurement questionnaires (WOMAC, KOOS, and SF12) will be completed at the time of randomization and at the conclusion of each week of exercise for a total of 9 times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water Treadmill | – | Behavioral: Water-based TreadmillThese subjects will participate in three monitored exercise sessions per week for 8 weeks using a water-based treadmill. |
| Land Treadmill | – | Behavioral: Land-based TreadmillThese subjects will participate in three monitored exercise sessions per week for 8 weeks using a land-based treadmill. |
| Exercise Cycle | – | Behavioral: Exercise CycleThese subjects will participate in three monitored exercise sessions per week for 8 weeks using an upright exercise cycle. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects for this study will be recruited from Penn State Milton S. Hershey Medical Center and surrounding communities via internal and external advertisements.
Key inclusion criteria (3 listed)
- Ages 30-60
- Knee pain
- Radiographically confirmed knee osteoarthritis
Key exclusion criteria (8 listed)
- Medical conditions contraindicating moderate aerobic exercise as determined through prescreening questions, ie: heart condition, asthma, history of stroke.
- Inability to exercise via treadmill or exercise cycle
- Contraindication to radiography
- Pregnancy
- History of recent joint injection (steroid, synvisc, etc.) within 6 weeks of study
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 |
|---|---|---|
| Exercise CycleAlso: Schwinn Windsprint Exercise CycleExercise regimen: three monitored exercise sessions per week for eight weeks using the upright exercise cycle. | Behavioural | Exercise Cycle |
| Land-based TreadmillAlso: True CS 6.0 treadmill, Nautilus NTR 700 treadmillExercise regimen: three monitored exercise sessions per week for eight weeks using the land-based treadmill. | Behavioural | Land Treadmill |
| Water-based TreadmillAlso: Hydroworx 2000 Series pool treadmillExercise regimen: three monitored exercise sessions per week for eight weeks using the water-based treadmill. | Behavioural | Water Treadmill |
Primary outcome
Exercise Tolerance
Time frame: 8 weeks
Exercise tolerance will be assessed based upon changes in symptoms related to knee osteoarthritis and exercise limitations related to those symptoms.
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 27 Feb 2015.
- Background: PubMed 10993420Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.
- Background: PubMed 17943863Bartels EM, Lund H, Hagen KB, Dagfinrud H, Christensen R, Danneskiold-Samsoe B. Aquatic exercise for the treatment of knee and hip osteoarthritis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005523. doi: 10.1002/14651858.CD005523.pub2.
- Background: PubMed 19752252Bosomworth NJ. Exercise and knee osteoarthritis: benefit or hazard? Can Fam Physician. 2009 Sep;55(9):871-8.
- Background: PubMed 20082694Cottrell E, Roddy E, Foster NE. The attitudes, beliefs and behaviours of GPs regarding exercise for chronic knee pain: a systematic review. BMC Fam Pract. 2010 Jan 18;11:4. doi: 10.1186/1471-2296-11-4.
- Background: PubMed 20434608Dunlop DD, Semanik P, Song J, Sharma L, Nevitt M, Jackson R, Mysiw J, Chang RW; Osteoarthritis Initiative Investigators. Moving to maintain function in knee osteoarthritis: evidence from the osteoarthritis initiative. Arch Phys Med Rehabil. 2010 May;91(5):714-21. doi: 10.1016/j.apmr.2010.01.015.
- Background: PubMed 20622537Dunn AL, Jewell JS. The effect of exercise on mental health. Curr Sports Med Rep. 2010 Jul-Aug;9(4):202-7. doi: 10.1249/JSR.0b013e3181e7d9af.
- Background: PubMed 8980206Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31.
- Background: PubMed 18843657Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
- Background: PubMed 17762377Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
- Background: PubMed 19001881Heckman GA, McKelvie RS. Cardiovascular aging and exercise in healthy older adults. Clin J Sport Med. 2008 Nov;18(6):479-85. doi: 10.1097/JSM.0b013e3181865f03.
- Background: PubMed 18163481Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177.
- Background: PubMed 13498604KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
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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.
Matthew Silvis, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Milton S. Hershey Medical Center 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 3 inclusion and 8 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 27 Feb 2015. 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. 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?
Exercise Tolerance (time frame: 8 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 NCT01359124, which also lists 21 linked publications.
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 27 Feb 2015.