Clinical Trial Finder

Dose Response of Exercise for Arthritis Management

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 ≥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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06880653
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of South Carolina
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Christine Pellegrini, PhD
Principal Investigator Affiliation University of South Carolina
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, U.S. Fed
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthritis, Rheumatoid Arthritis (RA), Gout, Fibromyalgia (FM), Osteoarthritis, Lupus Erythematosus, Systemic
Additional Details

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.

Arms & Interventions

Arms

Experimental: 45 minutes/week

Participants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity

Experimental: 90 minutes/week

Participants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity

Experimental: 150 minutes/week

Participants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of South Carolina, Columbia, South Carolina

Status

Recruiting

Address

University of South Carolina

Columbia, South Carolina, 29208

Site Contact

Christine Pellegrini

[email protected]

803-777-0911

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