ArthritisDREAMNCT06880653
Dose Response of Exercise for Arthritis Management
A study testing DREAM Adaptive Intervention in people with Arthritis and Rheumatoid Arthritis (RA), run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid Arthritis (RA), Gout
- What is being tested?
- DREAM Adaptive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years or older
- Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia
- Ability to read and write in English
Who cannot join
- 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)
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- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Christine Pellegrini, 803-777-0911, pellegca@mailbox.sc.edu
About this study
Official title: Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes
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.
Read the detailed description
All participants will be randomly assigned a physical activity goal (45 min/week, 90 min/week, or 150 min/week). To help participants achieve goals, they will receive a 6 month program which includes the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls. Participants may also receive additional calls, texts, or emails if they are struggling to meet their physical activity goals.
- Conditions
- Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic
- Being tested
- DREAM Adaptive Intervention
- Keywords
- arthritis, exercise, physical activity
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Gout, Fibromyalgia, Osteoarthritis, Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREAM Adaptive InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 45 minutes/week | Experimental | Participants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity Receives: Behavioral: DREAM Adaptive Intervention |
| 90 minutes/week | Experimental | Participants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity Receives: Behavioral: DREAM Adaptive Intervention |
| 150 minutes/week | Experimental | Participants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity Receives: Behavioral: DREAM Adaptive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function (6 Minute Walk Test)
Change in distance walked during the 6 minute walk test
Measured: Baseline to 6 months
Secondary outcomes (11)
Physical function (6 Minute Walk Test)
Change in distance walked during the 6 minute walk test
Measured: Baseline to 12 months
Physical function (chair stands)
Change in chair stand repetitions
Measured: Baseline to 6 months
Physical function (chair stands)
Change in chair stand repetitions
Measured: Baseline to 12 months
Health Related Quality of Life - Physical
Change in the physical component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Measured: Baseline to 6 months
Health Related Quality of Life - Physical
Change in the physical component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Measured: Baseline to 12 months
Health Related Quality of Life - Mental
Change in the mental component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Measured: Baseline to 6 months
Health Related Quality of Life - Mental
Change in the mental component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Measured: Baseline to 12 months
Pain intensity
Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.
Measured: Baseline to 6 months
Pain intensity
Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.
Measured: Baseline to 12 months
Depression symptoms
Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.
Measured: Baseline to 6 months
Depression symptoms
Change in depression symptoms using the CES-D. Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start28 Mar 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
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.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Christine A Pellegrini, PhD, University of South Carolina
- Investigators
- Christine Pellegrini, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880653
- Sponsor's protocol ID
- Pro00140006
- Other IDs
- U48DP006850
- Acronym
- DREAM
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available within 30 months of the completion of the project.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes
- ClinicalTrials.gov ID
- NCT06880653
- Acronym / sponsor ID
- DREAM / Pro00140006
- Conditions
- Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic
- Keywords
- arthritis, exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 18 Mar 2025 (actual)
- 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 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.
Detailed description
All participants will be randomly assigned a physical activity goal (45 min/week, 90 min/week, or 150 min/week). To help participants achieve goals, they will receive a 6 month program which includes the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls. Participants may also receive additional calls, texts, or emails if they are struggling to meet their physical activity goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 45 minutes/week | Experimental | Behavioral: DREAM Adaptive InterventionParticipants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity |
| 90 minutes/week | Experimental | Behavioral: DREAM Adaptive InterventionParticipants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity |
| 150 minutes/week | Experimental | Behavioral: DREAM Adaptive InterventionParticipants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia
- Ability to read and write in English
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| DREAM Adaptive Intervention6-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. | Behavioural | 150 minutes/week, 45 minutes/week, 90 minutes/week |
Primary outcome
Physical function (6 Minute Walk Test)
Time frame: Baseline to 6 months
Change in distance walked during the 6 minute walk test
11 secondary outcomes
Physical function (6 Minute Walk Test)
Time frame: Baseline to 12 months
Physical function (chair stands)
Time frame: Baseline to 6 months
Physical function (chair stands)
Time frame: Baseline to 12 months
Health Related Quality of Life - Physical
Time frame: Baseline to 6 months
Health Related Quality of Life - Physical
Time frame: Baseline to 12 months
Health Related Quality of Life - Mental
Time frame: Baseline to 6 months
Health Related Quality of Life - Mental
Time frame: Baseline to 12 months
Pain intensity
Time frame: Baseline to 6 months
Pain intensity
Time frame: Baseline to 12 months
Depression symptoms
Time frame: Baseline to 6 months
Depression symptoms
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made available within 30 months of the completion of the project.
Related trials for Arthritis
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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
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.
Christine Pellegrini, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DREAM Adaptive Intervention in people with Arthritis and Rheumatoid Arthritis (RA), run by University of South Carolina 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Wingard (803-777-1889, EWINGARD@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (6 Minute Walk Test) (time frame: Baseline to 6 months). 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 3 Apr 2026.