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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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