Dose Response of Exercise for Arthritis Management
DREAM
Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes
2 other identifiers
interventional
285
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 18, 2025
CompletedStudy Start
First participant enrolled
March 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
May 2, 2025
April 1, 2025
3.5 years
March 11, 2025
April 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical function (6 Minute Walk Test)
Change in distance walked during the 6 minute walk test
Baseline to 6 months
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Other Outcomes (2)
Physical activity (min/week)
Baseline to 6 months
Physical activity (min/week)
Baseline to 12 months
Study Arms (3)
45 minutes/week
EXPERIMENTALParticipants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity
90 minutes/week
EXPERIMENTALParticipants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity
150 minutes/week
EXPERIMENTALParticipants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity
Interventions
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.
Eligibility Criteria
You may qualify if:
- years or older
- Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia
- Ability to read and write in English
You may not qualify if:
- Have any contraindications to exercise (besides arthritis)
- Engage in ≥30 min/week of Actigraph assessed MVPA
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Carolina
Columbia, South Carolina, 29208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Pellegrini, PhD
University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 18, 2025
Study Start
March 28, 2025
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
April 30, 2029
Last Updated
May 2, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- De-identified data will be made available within 30 months of the completion of the project.
De-identified data will be made available within 30 months of the completion of the project.