Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes
New study explores how much exercise helps arthritis symptoms
Plain English Summary
Dose Response of Exercise for Arthritis Management is a Not Applicable clinical trial sponsored by University of South Carolina studying Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic. This study tests if different amounts of weekly exercise (45, 90, or 150 minutes) can improve arthritis symptoms. It is for adults aged 18 and older who have been diagnosed with arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Participants will follow a 6-month physical activity program with coaching, a guidebook, and a Fitbit, and will be assigned to one of the three exercise levels. Alternatives include standard medical care and other arthritis management programs. The trial aims to enroll 285 participants.
Official Summary
The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have a doctor-diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. You must be able to read and write in English. You cannot join if you have health issues that prevent exercise (other than arthritis), are pregnant or planning to become pregnant, or have uncontrolled high blood pressure. You also cannot join if you plan to move away from Columbia, SC, have a device not compatible with Fitbit, or are planning surgery that affects mobility in the next year. This trial is studying Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well participants can walk for 6 minutes, indicating improvements in their ability to move and perform daily activities. The specific primary outcome measures are: Physical function (6 Minute Walk Test) (Baseline to 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to find the optimal amount of physical activity needed to manage arthritis symptoms, filling a gap in personalized exercise recommendations for patients. This research targets Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in non-pharmacological treatments for arthritis, with potential to inform public health guidelines and the market for digital health tools and exercise programs.
Is This Trial Right for Me?
Ask your doctor if the exercise levels in this study are safe for you. You will participate in a 6-month program that includes monthly coaching calls, a guidebook, and a Fitbit to track your activity. Your daily life will involve aiming for a specific amount of exercise each week, depending on which group you are assigned to. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 285 participants
Interventions
- BEHAVIORAL: DREAM Adaptive Intervention — 6-month physical activity program (Dose Response of Exercise for Arthritis Management (DREAM)) which includes monthly phone coaching, Walk With Ease Guidebook, behavioral lessons, and a Fitbit. Participants may receive additional contact (email, text, or phone) if they struggle to meet activity goal.
Primary Outcomes
- Physical function (6 Minute Walk Test) (Baseline to 6 months)
Secondary Outcomes
- Physical function (6 Minute Walk Test) (Baseline to 12 months)
- Physical function (chair stands) (Baseline to 6 months)
- Physical function (chair stands) (Baseline to 12 months)
- Health Related Quality of Life - Physical (Baseline to 6 months)
- Health Related Quality of Life - Physical (Baseline to 12 months)
Full Eligibility Criteria
Inclusion Criteria: * 18 years or older * Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia * Ability to read and write in English Exclusion Criteria: * Have any contraindications to exercise (besides arthritis) * Engage in \>45 min/week of Actigraph assessed moderate to vigorous intensity activity * Are pregnant, breastfeeding, or planning to become pregnant in the next year * Are planning to relocate out of the Columbia, SC area in the next 12 months, * Do not have a device compatible with Fitbit * Have uncontrolled hypertension (e.g., systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg) * Plan to have a surgery that affects mobility in the next 12 months * Have a serious cognitive impairment. * Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes/week).
Trial Locations
- University of South Carolina, Columbia, South Carolina, United States
Frequently Asked Questions
What is clinical trial NCT06880653?
NCT06880653 is a Not Applicable INTERVENTIONAL study titled "Dose Response of Exercise for Arthritis Management." It is currently recruiting and is sponsored by University of South Carolina. The trial targets enrollment of 285 participants.
What conditions does NCT06880653 study?
This trial investigates treatments for Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic. The primary condition under study is Arthritis.
What treatments are being tested in NCT06880653?
The interventions being studied include: DREAM Adaptive Intervention (BEHAVIORAL). 6-month physical activity program (Dose Response of Exercise for Arthritis Management (DREAM)) which includes monthly phone coaching, Walk With Ease Guidebook, behavioral lessons, and a Fitbit. Participants may receive additional contact (email, text, or phone) if they struggle to meet activity goal.
What does Not Applicable mean for NCT06880653?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06880653?
This trial is currently "Recruiting." It started on 2025-03-28. The estimated completion date is 2029-04-30.
Who is sponsoring NCT06880653?
NCT06880653 is sponsored by University of South Carolina. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06880653?
The trial aims to enroll 285 participants. The trial is currently recruiting and accepting new participants.
How is NCT06880653 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06880653?
The primary outcome measures are: Physical function (6 Minute Walk Test) (Baseline to 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06880653 being conducted?
This trial is being conducted at 1 site, including Columbia, South Carolina (United States).
Where can I find official information about NCT06880653?
The official record for NCT06880653 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06880653. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06880653 testing in simple terms?
This study tests if different amounts of weekly exercise (45, 90, or 150 minutes) can improve arthritis symptoms. It is for adults aged 18 and older who have been diagnosed with arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia.
Why is this trial significant?
This trial is important because it aims to find the optimal amount of physical activity needed to manage arthritis symptoms, filling a gap in personalized exercise recommendations for patients.
What are the potential risks of participating in NCT06880653?
The main risks are related to exercise, such as muscle soreness, fatigue, or minor injuries. There is a small risk of overexertion or exacerbating existing arthritis pain if exercise is not done correctly. Some participants might experience frustration if they struggle to meet their exercise goals. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06880653?
Ask your doctor if the exercise levels in this study are safe for you. You will participate in a 6-month program that includes monthly coaching calls, a guidebook, and a Fitbit to track your activity. Your daily life will involve aiming for a specific amount of exercise each week, depending on which group you are assigned to. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06880653 signal from an investment perspective?
This trial signals a growing interest in non-pharmacological treatments for arthritis, with potential to inform public health guidelines and the market for digital health tools and exercise programs. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will follow a 6-month physical activity program with coaching, a guidebook, and a Fitbit, and will be assigned to one of the three exercise levels. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.