ArthritisPhase 2/3NCT00146367
Evaluation of the Active Living Every Day Exercise Program for People With Arthritis
A Phase 2/3 study testing Active Living Every Day in people with Arthritis, run by Centers for Disease Control and Prevention.
Trial summary
The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Active Living Every Day
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Oct 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported arthritis or chronic joint symptoms
- Currently exercising less than 3 times per week
- Plan to be in community for at least 1 year
- Physician release for participation in physical activity
Who cannot join
- Pregnancy
- Non-English speaking
- Cognitive impairment
- Serious medical condition where exercise is contradindicated
- Severe physical or mental impairment
About this study
Official title: Evaluation of the Health Benefits of the Active Living Every Day Physical Activity Program Among Persons With Arthritis
The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.
Read the detailed description
Evidence has shown that regular moderate-intensity physical activity improves symptoms and function in persons with arthritis. A 20-week behavior-based program was developed by the Cooper Institute, Brown University, and Human Kinetics to help people with sedentary lifestyles become and stay physically active. A randomized trial evaluated the effectiveness and efficacy of a similar program on which Active Living Every Day is based (ALED) on cardiovascular disease risk factors, cost-effectiveness, and cardiorespiratory fitness. However, the current research supporting ALED is limited for people with arthritis. The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. The primary goal will be accomplished through a twenty week randomized controlled trial conducted with 400 participants residing in the 17 Area Agencies on Aging housed in the Councils of Government in North Carolina, including both urban and rural counties. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.
Objectives:
- To demonstrate that the ALED program can increase physical activity and fitness levels among people with arthritis.
- To demonstrate that the Active Living Every Day has arthritis-specific benefits.
- To evaluate the feasibility of disseminating the Active Living Every Day program through the NC public health network.
- Conditions
- Arthritis
- Being tested
- Active Living Every Day
- Keywords
- arthritis, osteoarthritis, rheumatoid arthritis, rheumatic disease, exercise, physical activity, physical function, disability
- Medical subject headings
- Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Rheumatic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Living Every DayBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks
Secondary outcomes (5)
Functional status measured via HAQ at baseline and 20 weeks
Arthritis Self-efficacy measured at baseline and 20 weeks
Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
Pain, fatigue and stiffness VAS at baseline and 20 weeks
Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2004
- Study completionOct 2005
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 355 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of North Carolina
- Investigators
- Jennifer M Hootman, PhD, Study chair, Centers for Disease Control and PreventionLeigh F Callahan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146367
- Sponsor's protocol ID
- CDC-NCCDPHP-0444
- Other IDs
- CDC-NCCDPHP-MM-0444
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Health Benefits of the Active Living Every Day Physical Activity Program Among Persons With Arthritis
- ClinicalTrials.gov ID
- NCT00146367
- Acronym / sponsor ID
- CDC-NCCDPHP-0444
- Conditions
- Arthritis
- Keywords
- arthritis, osteoarthritis, rheumatoid arthritis, rheumatic disease, exercise, physical activity, physical function, disability
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of North Carolina
- Study start
- Jan 2004
- Study completion
- Oct 2005
- First posted
- 7 Sep 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 primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.
Detailed description
Evidence has shown that regular moderate-intensity physical activity improves symptoms and function in persons with arthritis. A 20-week behavior-based program was developed by the Cooper Institute, Brown University, and Human Kinetics to help people with sedentary lifestyles become and stay physically active. A randomized trial evaluated the effectiveness and efficacy of a similar program on which Active Living Every Day is based (ALED) on cardiovascular disease risk factors, cost-effectiveness, and cardiorespiratory fitness. However, the current research supporting ALED is limited for people with arthritis. The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. The primary goal will be accomplished through a twenty week randomized controlled trial conducted with 400 participants residing in the 17 Area Agencies on Aging housed in the Councils of Government in North Carolina, including both urban and rural counties. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.
Objectives:
- To demonstrate that the ALED program can increase physical activity and fitness levels among people with arthritis.
- To demonstrate that the Active Living Every Day has arthritis-specific benefits.
- To evaluate the feasibility of disseminating the Active Living Every Day program through the NC public health network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported arthritis or chronic joint symptoms
- Currently exercising less than 3 times per week
- Plan to be in community for at least 1 year
- Physician release for participation in physical activity
Key exclusion criteria (5 listed)
- Pregnancy
- Non-English speaking
- Cognitive impairment
- Serious medical condition where exercise is contradindicated
- Severe physical or mental impairment
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 |
|---|---|---|
| Active Living Every Day | Behavioural | – |
Primary outcome
Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks
5 secondary outcomes
Functional status measured via HAQ at baseline and 20 weeks
Arthritis Self-efficacy measured at baseline and 20 weeks
Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
Pain, fatigue and stiffness VAS at baseline and 20 weeks
Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months
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 14 Sep 2005.
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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
Leigh F Callahan, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Active Living Every Day in people with Arthritis, run by Centers for Disease Control and Prevention.
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 4 inclusion and 5 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 14 Sep 2005. 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.
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?
Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks. 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 14 Sep 2005.