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NCT Number: NCT06880653

Dose Response of Exercise for Arthritis Management

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.

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crystal Arthropathies Fibromyalgia Fibromyalgia (FM) Genetic Diseases, Inborn Gout Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Metabolic Diseases Metabolism, Inborn Errors Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Osteoarthritis Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Rheumatoid Arthritis (RA) Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location status: Recruiting

Location contact

Christine Pellegrini

CONTACT

[email protected]

803-777-0911

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DREAM Adaptive Intervention

Behavioral

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.

Primary outcomes

  1. Physical function (6 Minute Walk Test)

    Time frame: Baseline to 6 months

    Change in distance walked during the 6 minute walk test

Secondary outcomes

  1. Physical function (6 Minute Walk Test)

    Time frame: Baseline to 12 months

    Change in distance walked during the 6 minute walk test

  2. Physical function (chair stands)

    Time frame: Baseline to 6 months

    Change in chair stand repetitions

  3. Physical function (chair stands)

    Time frame: Baseline to 12 months

    Change in chair stand repetitions

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Other outcomes

  1. Physical activity (min/week)

    Time frame: Baseline to 6 months

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

  2. Physical activity (min/week)

    Time frame: Baseline to 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Wingard

CONTACT

[email protected]

803-777-1889

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes

Acronym: DREAM

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 18, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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