OsteoarthritisNCT00653497
Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis
A study testing Aquatic exercise in people with Osteoarthritis, run by University of Washington.
Trial summary
The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation aquatic exercise classes. DESIGN. Randomized trial of 20-week aquatic classes. SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis MEAURES. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Aquatic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- Mar 1997to Jun 1998
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diagnosis of osteoarthritis from a physician
- Aged 55 to 75
- Not currently exercising, defined as engaging in an average of less than 60 minutes of exercise/week during the last month
- Permission of the subject's primary physician to participate in the aquatic class
- Not currently enrolled in another medical study
- Not scheduled for joint replacement surgery during the study period
- Living in an area where Arthritis Foundation aquatic programs were offered
- Willingness to be randomized and to commit to the 5-month study period
Who cannot join
None listed.
About this study
The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation aquatic exercise classes.
- DESIGN. Randomized trial of 20-week aquatic classes.
- SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis
- MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)
- Conditions
- Osteoarthritis
- Being tested
- Aquatic exercise
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exerciseBehavioural
Arthritis Foundation Aquatics Program
- community-based aquatic exercise program
- participants asked to attend 2 classes per week for 20 weeks
- each class 45-60 minutes in duration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Community-based aquatic exercise program (Arthritis Foundation Aquatics Program). Two classes per week, 45-60 minutes in duration. Receives: Behavioral: Aquatic exercise |
| 2 | No intervention | Usual care; abstention from initiation of new exercise programs. Invited to participate in Arthritis Foundation Aquatics Program after study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Well-Being Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 1997
- Primary completionJun 1998
- Study completionJun 1998
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.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Donald L Patrick, PhD, MSPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653497
- Sponsor's protocol ID
- 28-0502-B/C
- Other IDs
- CDC U48/CCU009654-04, CDC U48/CCU009654-05
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 7 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis
- ClinicalTrials.gov ID
- NCT00653497
- Acronym / sponsor ID
- 28-0502-B/C
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 1997
- Primary completion
- Jun 1998 (actual)
- Study completion
- Jun 1998 (actual)
- First posted
- 7 Apr 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.
The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation aquatic exercise classes.
- DESIGN. Randomized trial of 20-week aquatic classes.
- SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis
- MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Aquatic exerciseCommunity-based aquatic exercise program (Arthritis Foundation Aquatics Program). Two classes per week, 45-60 minutes in duration. |
| 2 | No intervention | –Usual care; abstention from initiation of new exercise programs. Invited to participate in Arthritis Foundation Aquatics Program after study completion. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinically confirmed diagnosis of osteoarthritis from a physician
- Aged 55 to 75
- Not currently exercising, defined as engaging in an average of less than 60 minutes of exercise/week during the last month
- Permission of the subject's primary physician to participate in the aquatic class
- Not currently enrolled in another medical study
Key exclusion criteria (0 listed)
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 exerciseArthritis Foundation Aquatics Program * community-based aquatic exercise program * participants asked to attend 2 classes per week for 20 weeks * each class 45-60 minutes in duration | Behavioural | 1 |
Primary outcome
Quality of Well-Being Scale
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 7 Apr 2008.
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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.
Donald L Patrick, PhD, MSPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercise in people with Osteoarthritis, run by University of Washington.
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 8 inclusion and 0 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 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of Well-Being Scale. 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 7 Apr 2008.