OsteoarthritisNCT00735098
The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis
A study testing KBA exercise, strength training exercise and KBA and strength training in people with Osteoarthritis, run by University of Zululand at 1 site in United States.
Trial summary
Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain among adults. Recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- KBA exercise, strength training exercise and KBA and strength training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2012
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 years or over of either gender
- Self-reported knee pain
- Physician diagnosed tibiofemoral OA, unilateral or bilateral, per ACR guidelines
- Demonstrated minimal knee OA related dysfunction per WOMAC score
- Not engaged in a regular leg exercise program for minimum of 6 months
Who cannot join
- High risk health status per (e.g.) ACSM guidelines
- Inability to obtain physician release for exercise
- Unresolved balance disorder
- Unresolved neurological disorder
- History of knee surgery or major knee trauma injury
- Hip or ankle instability, excessive weakness, surgery or major trauma injury
- Hip or knee replacement
- Intra-articular joint injection within 4 weeks of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Zululand
St. Petersburg, Florida, 33712
About this study
Official title: The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis.
Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain among adults. Recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. KBA techniques are designed to improve dynamic joint stability by using a series of activities which challenge balance and coordination. To determine the independent effects of KBA training on functional abilities, it is necessary to test it as a training program unto itself. The proposed clinical trial is designed to do this by using three training groups: KBA only; lower extremity strength training only; and a combination of the two. The total exercise time and intensity of each condition will be approximately equal. A non-exercise group will control for any effects related to the testing procedures and the passage of time. Community volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will participate.
- Conditions
- Osteoarthritis
- Being tested
- KBA exercise, strength training exercise, KBA and strength training, Control group
- Keywords
- Knee Osteoarthritis, arthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBA exerciseOther
KBA exercise protocol, 3 times per week for 8 weeks
strength training exerciseOther
strength training exercise, 3 times per week for 8 weeks
KBA and strength trainingOther
KBA and strength training exercise, 3 times per week for 8 weeks
Control groupOther
8 week control group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | KBA exercise protocol Receives: Other: KBA exercise |
| 2 | Experimental | strength training exercise protocol Receives: Other: strength training exercise |
| 3 | Experimental | KBA and strength training protocol Receives: Other: KBA and strength training |
| 4 | Sham comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
(WOMAC) self assessment of physical function
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 posted14 Aug 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zululand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew W. Rogers, MS, University of Zululand
- Investigators
- Matthew W Rogers, MS, Principal investigator, University of Zululand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735098
- Sponsor's protocol ID
- KneeOAExercise-2
- Status last verified
- Feb 2013
- First submitted
- 12 Aug 2008
- Last updated
- 6 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT00735098
- Acronym / sponsor ID
- KneeOAExercise-2
- Conditions
- Osteoarthritis
- Keywords
- Knee Osteoarthritis, arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ZululandUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Aug 2008 (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.
Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain among adults. Recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. KBA techniques are designed to improve dynamic joint stability by using a series of activities which challenge balance and coordination. To determine the independent effects of KBA training on functional abilities, it is necessary to test it as a training program unto itself. The proposed clinical trial is designed to do this by using three training groups: KBA only; lower extremity strength training only; and a combination of the two. The total exercise time and intensity of each condition will be approximately equal. A non-exercise group will control for any effects related to the testing procedures and the passage of time. Community volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: KBA exerciseKBA exercise protocol |
| 2 | Experimental | Other: strength training exercisestrength training exercise protocol |
| 3 | Experimental | Other: KBA and strength trainingKBA and strength training protocol |
| 4 | Sham comparator | Other: Control group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 50 years or over of either gender
- Self-reported knee pain
- Physician diagnosed tibiofemoral OA, unilateral or bilateral, per ACR guidelines
- Demonstrated minimal knee OA related dysfunction per WOMAC score
- Not engaged in a regular leg exercise program for minimum of 6 months
Key exclusion criteria (8 listed)
- High risk health status per (e.g.) ACSM guidelines
- Inability to obtain physician release for exercise
- Unresolved balance disorder
- Unresolved neurological disorder
- History of knee surgery or major knee trauma injury
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 |
|---|---|---|
| KBA exerciseKBA exercise protocol, 3 times per week for 8 weeks | Other | 1 |
| strength training exercisestrength training exercise, 3 times per week for 8 weeks | Other | 2 |
| KBA and strength trainingKBA and strength training exercise, 3 times per week for 8 weeks | Other | 3 |
| Control group8 week control group | Other | 4 |
Primary outcome
(WOMAC) self assessment of physical function
Time frame: 8 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 6 Feb 2013.
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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 W Rogers, MS principal investigator
University of Zululand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KBA exercise, strength training exercise and KBA and strength training in people with Osteoarthritis, run by University of Zululand 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 5 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 6 Feb 2013. 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?
(WOMAC) self assessment of physical function (time frame: 8 weeks). 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 6 Feb 2013.