Dose Response of Exercise for Arthritis Management (DREAM)

April 2, 2026 updated by: Christine A Pellegrini, PhD, University of South Carolina

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • Recruiting
        • University of South Carolina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
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
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 is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function (6 Minute Walk Test)
Time Frame: Baseline to 6 months
Change in distance walked during the 6 minute walk test
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function (6 Minute Walk Test)
Time Frame: Baseline to 12 months
Change in distance walked during the 6 minute walk test
Baseline to 12 months
Physical function (chair stands)
Time Frame: Baseline to 6 months
Change in chair stand repetitions
Baseline to 6 months
Physical function (chair stands)
Time Frame: Baseline to 12 months
Change in chair stand repetitions
Baseline to 12 months
Health Related Quality of Life - Physical
Time Frame: Baseline to 6 months
Change in the physical component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Baseline to 6 months
Health Related Quality of Life - Physical
Time Frame: Baseline to 12 months
Change in the physical component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Baseline to 12 months
Health Related Quality of Life - Mental
Time Frame: Baseline to 6 months
Change in the mental component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Baseline to 6 months
Health Related Quality of Life - Mental
Time Frame: Baseline to 12 months
Change in the mental component score of the SF-12v2 Health Survey. Scores range from 0-100, with higher scores reflective of better health.
Baseline to 12 months
Pain intensity
Time Frame: Baseline to 6 months
Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.
Baseline to 6 months
Pain intensity
Time Frame: Baseline to 12 months
Change in pain as measured by a visual analog scale. Scores range from 0-100, with higher scores reflective of higher pain.
Baseline to 12 months
Depression symptoms
Time Frame: Baseline to 6 months
Change in depression symptoms using the CES-D. Scores range from 0-60, with higher scores reflective of more depression symptoms.
Baseline to 6 months
Depression symptoms
Time Frame: Baseline to 12 months
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.
Baseline to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity (min/week)
Time Frame: Baseline to 6 months
Change in Actigraph-assessed moderate-to-vigorous intensity physical activity
Baseline to 6 months
Physical activity (min/week)
Time Frame: Baseline to 12 months
Change in Actigraph-assessed moderate-to-vigorous intensity physical activity
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Christine Pellegrini, PhD, University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00140006
  • U48DP006850 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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