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RecruitingNCT06880653DREAMUpdated Apr 3, 2026

Dose Response of Exercise for Arthritis Management

An interventional study of DREAM Adaptive Intervention in Arthritis, Rheumatoid Arthritis (RA) and Gout, sponsored by University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by University of South Carolina · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
285
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Arthritis
  • Rheumatoid Arthritis (RA)
  • Gout
  • Fibromyalgia (FM)
  • Osteoarthritis
  • Lupus Erythematosus, Systemic

Keywords

  • arthritis
  • exercise
  • physical activity
03

In context

Arthritis

843 studies on the registry are indexed under Arthritis; 118 are open to participants now.

This study's planned enrollment of 285 is above the median of 97 across 599 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.

Browse University of South Carolina studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Have any 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
285 participants (estimated)

Study arms

  • Experimental
    45 minutes/week

    Participants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity

    Behavioral: DREAM Adaptive Intervention

  • Experimental
    90 minutes/week

    Participants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity

    Behavioral: DREAM Adaptive Intervention

  • Experimental
    150 minutes/week

    Participants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity

    Behavioral: DREAM Adaptive Intervention

Interventions

  • BehavioralDREAM 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.

06

What researchers measure

Primary outcomes

  1. Physical function (6 Minute Walk Test)

    Change in distance walked during the 6 minute walk test

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Physical function (6 Minute Walk Test)

    Change in distance walked during the 6 minute walk test

    Time frame: Baseline to 12 months

  2. Physical function (chair stands)

    Change in chair stand repetitions

    Time frame: Baseline to 6 months

  3. Physical function (chair stands)

    Change in chair stand repetitions

    Time frame: Baseline to 12 months

  4. 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.

    Time frame: Baseline to 6 months

  5. 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.

    Time frame: Baseline to 12 months

  6. 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.

    Time frame: Baseline to 6 months

  7. 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.

    Time frame: Baseline to 12 months

  8. Pain intensity

    Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.

    Time frame: Baseline to 6 months

  9. Pain intensity

    Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.

    Time frame: Baseline to 12 months

  10. Depression symptoms

    Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.

    Time frame: Baseline to 6 months

  11. 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.

    Time frame: Baseline to 12 months

Other outcomes

  1. Physical activity (min/week)

    Change in Actigraph-assessed moderate-to-vigorous intensity physical activity

    Time frame: Baseline to 6 months

  2. Physical activity (min/week)

    Change in Actigraph-assessed moderate-to-vigorous intensity physical activity

    Time frame: Baseline to 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be made available within 30 months of the completion of the project.

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: De-identified data will be made available within 30 months of the completion of the project.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Oct 2028, 42 months after the start.

Of 134 non-industry interventional studies with no phase under Arthritis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 42 months is above that.

Counting every sponsor, half of 167 studies reached it within 31 months; a quarter within 13 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2025
First posted
Mar 18, 2025
StartActual
Mar 28, 2025
Primary completionEst.
Oct 1, 2028
CompletionEst.
Apr 30, 2029
Last update
Apr 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06880653
Lead sponsor
University of South Carolina
Collaborators
Centers for Disease Control and Prevention
Responsible party
Christine A Pellegrini, PhD (Associate Professor, University of South Carolina) — Principal investigator
First posted
Mar 18, 2025
Start date
Mar 28, 2025
Primary completion
Oct 1, 2028 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Apr 3, 2026

Study contacts

Ellen Wingard
Contact
EWINGARD@mailbox.sc.edu
803-777-1889
Christine Pellegrini, PhD
principal investigator · University of South Carolina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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