Knee OsteoarthritisNCT01245283
Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
A study testing normal activities and clinical care, Concentric Focused Resistance Exercise and Eccentric Focused Resistance Exercise in people with Knee Osteoarthritis, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- normal activities and clinical care, Concentric Focused Resistance Exercise and Eccentric Focused Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis (OA) of the knee for >6 months
- moderate to severe pain immediately following a 50-foot walk
- knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
- bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
- willing and able to participate in regular exercise for four months
- free from musculoskeletal limitations that would preclude resistance exercise participation
- free of abnormal cardiovascular responses during the screening graded maximal walk test
Who cannot join
- unable to walk
- regular resistance exercise training (>3X week) within the past 6 months
- specific low back pain or acute back injury
- spinal stenosis that precludes walking one block due to neurogenic claudication
- any major injury to either knee within the prior 12 months
- any surgery to either knee within the last 12 months
Show all 11Show fewer
- lumbar radiculopathy
- vascular claudication
- significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee
- have had corticosteroid or viscosupplement injections within three months of study participation
- have added new over the counter or prescription pain medication within two months of study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.
- Conditions
- Knee Osteoarthritis
- Being tested
- normal activities and clinical care, Concentric Focused Resistance Exercise, Eccentric Focused Resistance Exercise
- Keywords
- knee, osteoarthritis, pain, function, impairment
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal activities and clinical careOther
Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines
Concentric Focused Resistance ExerciseOther
Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Eccentric Focused Resistance ExerciseOther
Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list Non-exercise Control (CON) | Active comparator | Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group. Receives: Other: normal activities and clinical care |
| Concentric Focused RX (CRX) | Active comparator | Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. Receives: Other: Concentric Focused Resistance Exercise |
| Eccentric Focused RX (ERX) | Active comparator | The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while "assistance" is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. Receives: Other: Eccentric Focused Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.
Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible).
0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)
Measured: Baseline, 4 Months
Secondary outcomes (8)
Six Minute Walk Test; Change From Baseline at 4 Months
Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.
Measured: Baseline, 4 Months
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.
Measured: Baseline, 4 Months
Leg Press Test; Change From Baseline at 4 Months
Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.
Measured: Baseline, 4 Months
Leg Extensions Test; Change From Baseline at 4 Months
Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.
Measured: Baseline, 4 Months
Leg Curl Test; Change From Baseline at 4 Months
Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.
Measured: Baseline, 4 Months
Chest Press; Change From Baseline at 4 Months
Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.
Measured: Baseline, 4 Months
Shoulder Press Test; Change From Baseline at 4 Months
Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.
Measured: Baseline, 4 Months
Seated Row Test; Change From Baseline at 4 Months
Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.
Measured: Baseline, 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin R Vincent, M.D. Ph.D., Principal investigator, University of Florida Department of Orthopaedics and Rehabilitaion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245283
- Sponsor's protocol ID
- 614-2009
- Status last verified
- Nov 2014
- First submitted
- 5 Nov 2010
- Last updated
- 5 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
- ClinicalTrials.gov ID
- NCT01245283
- Acronym / sponsor ID
- 614-2009
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, pain, function, impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 8 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wait-list Non-exercise Control (CON) | Active comparator | Other: normal activities and clinical careSubjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group. |
| Concentric Focused RX (CRX) | Active comparator | Other: Concentric Focused Resistance ExerciseTraining protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. |
| Eccentric Focused RX (ERX) | Active comparator | Other: Eccentric Focused Resistance ExerciseThe Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while "assistance" is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Osteoarthritis (OA) of the knee for >6 months
- moderate to severe pain immediately following a 50-foot walk
- knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
- bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
- willing and able to participate in regular exercise for four months
Key exclusion criteria (11 listed)
- unable to walk
- regular resistance exercise training (>3X week) within the past 6 months
- specific low back pain or acute back injury
- spinal stenosis that precludes walking one block due to neurogenic claudication
- any major injury to either knee within the prior 12 months
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 |
|---|---|---|
| normal activities and clinical careSubjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines | Other | Wait-list Non-exercise Control (CON) |
| Concentric Focused Resistance ExerciseTwo resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. | Other | Concentric Focused RX (CRX) |
| Eccentric Focused Resistance ExerciseTwo resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press. | Other | Eccentric Focused RX (ERX) |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status. Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible). 0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)
8 secondary outcomes
Six Minute Walk Test; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Leg Press Test; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Leg Extensions Test; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Leg Curl Test; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Chest Press; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Shoulder Press Test; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Seated Row Test; Change From Baseline at 4 Months
Time frame: Baseline, 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kevin R Vincent, M.D. Ph.D. principal investigator
University of Florida Department of Orthopaedics and Rehabilitaion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal activities and clinical care, Concentric Focused Resistance Exercise and Eccentric Focused Resistance Exercise in people with Knee Osteoarthritis, run by University of Florida 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 7 inclusion and 11 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 5 Dec 2014. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months (time frame: Baseline, 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2014.