AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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:

  1. 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.
  2. People with inflammatory joint disease can have healthy physical activity levels and weight at home and in the community.
  3. 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.

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.

  1. Normal body mass index is normal

  2. At least four days of 20 minutes exercise in past seven

Secondary outcomes (7)
  1. Weight loss of five pounds

  2. Increased exercise days by 2

  3. Improved quality of life (including reduced pain) as measured with the AIMS-2

  4. Improved dietary characteristics as measured with the Block FFQ

  5. Increased physical activity as measured with the Physical ACtivity History

  6. Reduced depressive symptoms via CES-D

  7. Improved physical performance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2006 (estimated)
  2. Study startOct 2003
  3. Study completionFeb 2006

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in