Knee OsteoarthritisNCT00904319
Aquatic Power Training
A study testing Aquatic Power Training in people with Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial summary
Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Aquatic Power Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2009
- 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
- Age 50 or older
- Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by the American College of Rheumatology criteria and frequent knee symptoms)
Who cannot join
- bilateral knee replacement
- acute or terminal illness
- unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring use of supplement oxygen, or lower limb musculoskeletal surgery in the past 6 months
- unwilling to be in a pool (approximately 4 feet deep)
- 400m walk time equal to or slower than the median for sex and decade:
- M 50's 250.2 60's 289.9 70's+ 290.8
- F 50's 315.9 60's 305.2 70's+ 292.5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Mobility in Older Adults With Knee Osteoarthritis: Aquatic Power Training
Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis.
Read the detailed description
Aquatic based training can offer many of the same benefits associated with a land based exercises but water has certain properties that provide a more gentle and welcoming environment for exercising. Buoyancy in water counteracts gravity to support the weight of the subject and decrease the forces put on the joints. Viscosity of water can provide resistance proportional to the effort exerted and with gentle friction enhancing proprioceptive feedback. Immersing in warm water can cause an increase in body temperature due to specific heat and thermal conductivity, which can cause blood vessels to dilate. In addition, hydrostatic forces reduce edema, increasing venous return and healthy circulation. [Prins, 1999]; [Wilder, 1998]
Studies have shown that water based exercise has been proven to significantly decrease pain in people with knee osteoarthritis compared to those in a land based exercise program. [Silva, 2003] In comparing an aquatic physical therapy session to a no intervention group the aquatic program resulted in less pain, improved physical function, quality of life, and strength. [Hinman, 2007]
The purpose of this research study is to determine whether an aquatic therapy program aimed at increasing muscle power will be effective in improving knee symptoms and mobility in men and women with symptomatic knee osteoarthritis.
The purpose of this study is to assess the efficacy of aquatic power training for improving mobility limitations, disability and quality of life in older adults with symptomatic knee OA.
Hypothesis 1: In older adults with symptomatic knee OA, a 6-week aquatic power training intervention will reduce lower limb mobility limitations (400m walk time).
Hypothesis 2: In comparison to baseline measures, at 6-week follow-up, there will be improvements in a) lower limb function (LLFDI), b) quality of life (KOOS Knee QOL),c) knee OA specific pain (KOOS pain) scores, and d) vastus lateralis muscle bulk (thigh muscle). These changes will be sustained at 12 week follow-up.
- Conditions
- Knee Osteoarthritis
- Being tested
- Aquatic Power Training
- Keywords
- osteoarthritis, knee pain, power training, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Power TrainingOther
Aquatic power training program with an exercise specialist 2/week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic | Experimental | Aquatic Power Training Receives: Other: Aquatic Power Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
400 meter walk time
Measured: 0, 6, and 12 weeks
Secondary outcomes (4)
Lower limb function (LLFDI)
Measured: 0, 6, and 12 weeks
Quality of life (KOOS)
Measured: 0, 6, and 12 weeks
Knee osteoarthritis pain (KOOS pain scores)
Measured: 0 and 6 weeks
Vastus lateralis muscle bulk
Measured: 0, 2, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- Neil A Segal, MD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904319
- Sponsor's protocol ID
- 200903762
- Status last verified
- Jun 2010
- First submitted
- 15 May 2009
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Mobility in Older Adults With Knee Osteoarthritis: Aquatic Power Training
- ClinicalTrials.gov ID
- NCT00904319
- Acronym / sponsor ID
- 200903762
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, knee pain, power training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 May 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.
Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis.
Detailed description
Aquatic based training can offer many of the same benefits associated with a land based exercises but water has certain properties that provide a more gentle and welcoming environment for exercising. Buoyancy in water counteracts gravity to support the weight of the subject and decrease the forces put on the joints. Viscosity of water can provide resistance proportional to the effort exerted and with gentle friction enhancing proprioceptive feedback. Immersing in warm water can cause an increase in body temperature due to specific heat and thermal conductivity, which can cause blood vessels to dilate. In addition, hydrostatic forces reduce edema, increasing venous return and healthy circulation. [Prins, 1999]; [Wilder, 1998]
Studies have shown that water based exercise has been proven to significantly decrease pain in people with knee osteoarthritis compared to those in a land based exercise program. [Silva, 2003] In comparing an aquatic physical therapy session to a no intervention group the aquatic program resulted in less pain, improved physical function, quality of life, and strength. [Hinman, 2007]
The purpose of this research study is to determine whether an aquatic therapy program aimed at increasing muscle power will be effective in improving knee symptoms and mobility in men and women with symptomatic knee osteoarthritis.
The purpose of this study is to assess the efficacy of aquatic power training for improving mobility limitations, disability and quality of life in older adults with symptomatic knee OA.
Hypothesis 1: In older adults with symptomatic knee OA, a 6-week aquatic power training intervention will reduce lower limb mobility limitations (400m walk time).
Hypothesis 2: In comparison to baseline measures, at 6-week follow-up, there will be improvements in a) lower limb function (LLFDI), b) quality of life (KOOS Knee QOL),c) knee OA specific pain (KOOS pain) scores, and d) vastus lateralis muscle bulk (thigh muscle). These changes will be sustained at 12 week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquatic | Experimental | Other: Aquatic Power TrainingAquatic Power Training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50 or older
- Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by the American College of Rheumatology criteria and frequent knee symptoms)
Key exclusion criteria (7 listed)
- bilateral knee replacement
- acute or terminal illness
- unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring use of supplement oxygen, or lower limb musculoskeletal surgery in the past 6 months
- unwilling to be in a pool (approximately 4 feet deep)
- 400m walk time equal to or slower than the median for sex and decade:
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 |
|---|---|---|
| Aquatic Power TrainingAquatic power training program with an exercise specialist 2/week for 6 weeks. | Other | Aquatic |
Primary outcome
400 meter walk time
Time frame: 0, 6, and 12 weeks
4 secondary outcomes
Lower limb function (LLFDI)
Time frame: 0, 6, and 12 weeks
Quality of life (KOOS)
Time frame: 0, 6, and 12 weeks
Knee osteoarthritis pain (KOOS pain scores)
Time frame: 0 and 6 weeks
Vastus lateralis muscle bulk
Time frame: 0, 2, 6, and 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 25 Jun 2010.
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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.
Neil A Segal, MD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Power Training in people with Knee Osteoarthritis, run by University of Iowa 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 2 inclusion and 7 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 25 Jun 2010. 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?
400 meter walk time (time frame: 0, 6, and 12 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 25 Jun 2010.