ArthritisPhase 2/3NCT00252070
Fitness and Exercise for People With Arthritis
A Phase 2/3 study testing Functional Exercise for People with Arthritis (FEPA) in people with Arthritis, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- Functional Exercise for People with Arthritis (FEPA)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2007
- Phase
- Phase 2/3
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported doctor-diagnosed arthritis
- No physical limitations precluding exercise participation
- Negative screen for CVD (PAR-Q)
- Age 20+
- English or Spanish speaking
Who cannot join
- Presence of any condition for which exercise is contraindicated
- Physical inability to complete exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: Fitness and Functional Exercise for People With Arthritis
The purpose of this study is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis.
Read the detailed description
There is evidence that people with arthritis who participate in appropriate types of physical activity can improve physical function and pain management. Most existing programs focus on improving flexibility and balance. Less attention has been paid to conditioning and overall functional fitness. To address some of these concerns, this study will develop, evaluate, and implement a non-aquatic physical activity program to increase health-related functional fitness in community-dwelling adults with arthritis. Specific goals are:
- To develop a systematic and progressive program (FEPA: Functional Exercise for Persons with Arthritis) that integrates muscular and aerobic conditioning, balance and trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement patterns that mimic those used in everyday activities.
- Implement the FEPA program in an ethnically diverse, low SES community sample of older adults with arthritis.
- Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA program for increasing short- and immediate-term health and functional fitness outcomes.
- Evaluate the sustainability of the FEPA program through a program logic model process and identify inputs, activities and outputs that contribute to successful program implementation and the building of community capacity to support long-term program maintenance.
- Conditions
- Arthritis
- Being tested
- Functional Exercise for People with Arthritis (FEPA)
- Keywords
- arthritis, exercise, function, pain
- Medical subject headings
- Arthritis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Exercise for People with Arthritis (FEPA)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk
8-foot up-and-go
Arm curl
Back scratch
AIMS-2
Secondary outcomes (3)
Arthritis self-efficacy
Physical activity level
Pain VAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startNov 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Jennifer M Hootman, PhD, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252070
- Sponsor's protocol ID
- CDC-NCCDPHP-ASPH3497
- Other IDs
- ASPH3497
- Status last verified
- Sep 2007
- First submitted
- 10 Nov 2005
- Last updated
- 10 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness and Functional Exercise for People With Arthritis
- ClinicalTrials.gov ID
- NCT00252070
- Acronym / sponsor ID
- CDC-NCCDPHP-ASPH3497
- Conditions
- Arthritis
- Keywords
- arthritis, exercise, function, pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Nov 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Nov 2005 (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 is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis.
Detailed description
There is evidence that people with arthritis who participate in appropriate types of physical activity can improve physical function and pain management. Most existing programs focus on improving flexibility and balance. Less attention has been paid to conditioning and overall functional fitness. To address some of these concerns, this study will develop, evaluate, and implement a non-aquatic physical activity program to increase health-related functional fitness in community-dwelling adults with arthritis. Specific goals are:
- To develop a systematic and progressive program (FEPA: Functional Exercise for Persons with Arthritis) that integrates muscular and aerobic conditioning, balance and trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement patterns that mimic those used in everyday activities.
- Implement the FEPA program in an ethnically diverse, low SES community sample of older adults with arthritis.
- Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA program for increasing short- and immediate-term health and functional fitness outcomes.
- Evaluate the sustainability of the FEPA program through a program logic model process and identify inputs, activities and outputs that contribute to successful program implementation and the building of community capacity to support long-term program maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported doctor-diagnosed arthritis
- No physical limitations precluding exercise participation
- Negative screen for CVD (PAR-Q)
- Age 20+
- English or Spanish speaking
Key exclusion criteria (2 listed)
- Presence of any condition for which exercise is contraindicated
- Physical inability to complete exercise program
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 |
|---|---|---|
| Functional Exercise for People with Arthritis (FEPA) | Behavioural | – |
Primary outcome
Six-minute walk
8-foot up-and-go
Arm curl
Back scratch
AIMS-2
3 secondary outcomes
Arthritis self-efficacy
Physical activity level
Pain VAS
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 10 Sep 2007.
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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.
Jennifer M Hootman, PhD study chair
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Functional Exercise for People with Arthritis (FEPA) in people with Arthritis, run by Centers for Disease Control and Prevention 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 2 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 10 Sep 2007. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Six-minute walk. The study lists 5 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 10 Sep 2007.