Rheumatoid ArthritisNCT00365404
Activity, Rheumatoid and Osteoarthritis, and Weight Management
A study testing Diet and exercise promotion in people with Rheumatoid Arthritis and Osteoarthritis, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of the study was to implement well-developed guidelines for arthritis management beyond acute medical management to independent community living by modifying existing weight management and physical activity promotion programs for people with disabling arthritis. Our hypotheses were: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- Diet and exercise promotion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 465 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Feb 2006
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men and women
- A medical visit at one of six Park Nicollet Health System sites from November 2003 through June 2004.
- ICD-9 visit code of 714.0, 715.90 or 715.95 through 715.97
- Patient's clinician provided written consent to invite participation
- Patients had previously consented to be contacted for research purposes.
Who cannot join
- The patient was unaware of a medical diagnosis of arthritis.
- They did not report having a medical provider they could call with arthritis-related questions
- Arthritis-related problems for less than nine months duration for rheumatoid arthritis, less than three months for osteoarthritis.
- Scheduled for surgery.
- History of lower extremity joint replacement.
- Less than daily arthritis pain or problems.
- History of chest pain or medically restricted activity.
- Unable to participate for 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416
About this study
Official title: Weight Management, Physical Activity, Less Disability in Rheumatoid and Osteoarthritis
The purpose of the study was to implement well-developed guidelines for arthritis management beyond acute medical management to independent community living by modifying existing weight management and physical activity promotion programs for people with disabling arthritis.
Our hypotheses were:
- Existing individual, health care system, and community strategies to promote physical activity and weight management can effectively be modified and expanded to include those with debilitating joint diseases.
- People with inflammatory joint disease can have healthy physical activity levels and weight at home and in the community.
- The effect of these interventions will be higher quality of life, lower depression rates, modest pain levels, and functional independence.
Read the detailed description
Park Nicollet Clinic and the Institute for Clinical Systems Integration have spent several million dollars developing evidence-based care guidelines and intervention strategies for a wide range of common illnesses. Included in the degenerative joint disease guideline are recommendations for the management of two inter-related risk factors for increased disability: obesity and lack of physical activity. This application seeks to integrate disability prevention programs into the post-acute management of rheumatoid and osteoarthritis.
Our specific aims are to: (1) Modify well-established weight management techniques and physical activity promotion interventions according to Institute for Clinical Systems Integration recommendations for use by the broader community of individuals with potentially disabling rheumatoid and osteoarthritis; (2) Implement these interventions within a diverse patient population identified within an integrated health care system; (3) Demonstrate the short and long term impact of these interventions on patients suffering from debilitating joint disease; and (4) Facilitate incorporation of these interventions by other communities and clinical settings to enhance the longer-term well being of those with disabilities.
To achieve our aims, we will modify existing weight management and physical activity promotion strategies across the continuum of care. Through patient focus groups, a clinical advisory board, a community advisory board, and pilot testing, key stakeholders will help assure effective program design and implementation strategies as well as development of sustainable interventions. Using pre- and post-intervention surveys and simple measures of physical ability and weight, we will demonstrate the effect of these interventions on physical activity levels and weight; assess the effect of the interventions on pain, quality of life, depression, and functional capacity in those diagnosed with rheumatoid or osteoarthritis; and document the implementation strategies for the community interventions.
Our aims and hypotheses are consistent with the overarching goals of Healthy People 2010: (1) to increase quality and years of healthy life and (2) to eliminate health disparities. We address two focus areas, (2) arthritis and (6) disability and secondary conditions. Our intervention targets two of the leading health indicators: physical activity and overweight and obesity.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- Diet and exercise promotion
- Keywords
- Behavioral change, Weight management, Physical activity
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exercise promotionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal body mass index is normal
At least four days of 20 minutes exercise in past seven
Secondary outcomes (7)
Weight loss of five pounds
Increased exercise days by 2
Improved quality of life (including reduced pain) as measured with the AIMS-2
Improved dietary characteristics as measured with the Block FFQ
Increased physical activity as measured with the Physical ACtivity History
Reduced depressive symptoms via CES-D
Improved physical performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startOct 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 465 participants
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Barbara L Braun, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365404
- Sponsor's protocol ID
- 01802-03-C
- Other IDs
- R04/CCR523273-03-2
- Status last verified
- Jul 2006
- First submitted
- 16 Aug 2006
- Last updated
- 26 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management, Physical Activity, Less Disability in Rheumatoid and Osteoarthritis
- ClinicalTrials.gov ID
- NCT00365404
- Acronym / sponsor ID
- 01802-03-C
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Keywords
- Behavioral change, Weight management, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2003
- Study completion
- Feb 2006
- First posted
- 17 Aug 2006 (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 the study was to implement well-developed guidelines for arthritis management beyond acute medical management to independent community living by modifying existing weight management and physical activity promotion programs for people with disabling arthritis.
Our hypotheses were:
- Existing individual, health care system, and community strategies to promote physical activity and weight management can effectively be modified and expanded to include those with debilitating joint diseases.
- People with inflammatory joint disease can have healthy physical activity levels and weight at home and in the community.
- The effect of these interventions will be higher quality of life, lower depression rates, modest pain levels, and functional independence.
Detailed description
Park Nicollet Clinic and the Institute for Clinical Systems Integration have spent several million dollars developing evidence-based care guidelines and intervention strategies for a wide range of common illnesses. Included in the degenerative joint disease guideline are recommendations for the management of two inter-related risk factors for increased disability: obesity and lack of physical activity. This application seeks to integrate disability prevention programs into the post-acute management of rheumatoid and osteoarthritis.
Our specific aims are to: (1) Modify well-established weight management techniques and physical activity promotion interventions according to Institute for Clinical Systems Integration recommendations for use by the broader community of individuals with potentially disabling rheumatoid and osteoarthritis; (2) Implement these interventions within a diverse patient population identified within an integrated health care system; (3) Demonstrate the short and long term impact of these interventions on patients suffering from debilitating joint disease; and (4) Facilitate incorporation of these interventions by other communities and clinical settings to enhance the longer-term well being of those with disabilities.
To achieve our aims, we will modify existing weight management and physical activity promotion strategies across the continuum of care. Through patient focus groups, a clinical advisory board, a community advisory board, and pilot testing, key stakeholders will help assure effective program design and implementation strategies as well as development of sustainable interventions. Using pre- and post-intervention surveys and simple measures of physical ability and weight, we will demonstrate the effect of these interventions on physical activity levels and weight; assess the effect of the interventions on pain, quality of life, depression, and functional capacity in those diagnosed with rheumatoid or osteoarthritis; and document the implementation strategies for the community interventions.
Our aims and hypotheses are consistent with the overarching goals of Healthy People 2010: (1) to increase quality and years of healthy life and (2) to eliminate health disparities. We address two focus areas, (2) arthritis and (6) disability and secondary conditions. Our intervention targets two of the leading health indicators: physical activity and overweight and obesity.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult men and women
- A medical visit at one of six Park Nicollet Health System sites from November 2003 through June 2004.
- ICD-9 visit code of 714.0, 715.90 or 715.95 through 715.97
- Patient's clinician provided written consent to invite participation
- Patients had previously consented to be contacted for research purposes.
Key exclusion criteria (8 listed)
- The patient was unaware of a medical diagnosis of arthritis.
- They did not report having a medical provider they could call with arthritis-related questions
- Arthritis-related problems for less than nine months duration for rheumatoid arthritis, less than three months for osteoarthritis.
- Scheduled for surgery.
- History of lower extremity joint replacement.
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 |
|---|---|---|
| Diet and exercise promotion | Behavioural | – |
Primary outcome
Normal body mass index is normal
At least four days of 20 minutes exercise in past seven
7 secondary outcomes
Weight loss of five pounds
Increased exercise days by 2
Improved quality of life (including reduced pain) as measured with the AIMS-2
Improved dietary characteristics as measured with the Block FFQ
Increased physical activity as measured with the Physical ACtivity History
Reduced depressive symptoms via CES-D
Improved physical performance
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 26 Nov 2015.
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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.
Barbara L Braun, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise promotion in people with Rheumatoid Arthritis and Osteoarthritis, run by HealthPartners Institute 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 26 Nov 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?
Normal body mass index is normal. The study lists 2 primary outcomes in all. 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 26 Nov 2015.