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Recruiting NCT06880653

Dose Response of Exercise for Arthritis Management

No phase Interventional Arthritis Rheumatoid Arthritis (RA) Gout Fibromyalgia (FM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DREAM Adaptive Intervention.
Who it may be relevant to
Registry conditions: Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Physical function (6 Minute Walk Test) [Time frame: Baseline to 6 months]
Secondary outcome measures (11)
  • Physical function (6 Minute Walk Test) [Time frame: Baseline to 12 months]
  • Physical function (chair stands) [Time frame: Baseline to 6 months]
  • Physical function (chair stands) [Time frame: Baseline to 12 months]
  • Health Related Quality of Life - Physical [Time frame: Baseline to 6 months]
  • Health Related Quality of Life - Physical [Time frame: Baseline to 12 months]
  • Health Related Quality of Life - Mental [Time frame: Baseline to 6 months]
  • Health Related Quality of Life - Mental [Time frame: Baseline to 12 months]
  • Pain intensity [Time frame: Baseline to 6 months]
  • Pain intensity [Time frame: Baseline to 12 months]
  • Depression symptoms [Time frame: Baseline to 6 months]
  • Depression symptoms [Time frame: Baseline to 12 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of South Carolina — Columbia

Identifiers

NCT: NCT06880653 · Pro00140006 · U48DP006850

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗