An interventional study of Multicomponent exercise and Nutrition in Arthritis, Osteoarthritis and Rheumatoid Arthritis, sponsored by University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University of South Carolina · Not applicable, Interventional, and Prevention
The purpose of this study is to examine the effectiveness and safety of a self-directed physical activity program relative to a self-directed dietary program in adults with arthritis. A process evaluation will also be conducted to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction.
Physical activity is a critical component of arthritis disease management. It also reduces the risk for other chronic comorbid conditions in people with arthritis. Yet, most adults with arthritis are not sufficiently active at the level needed to achieve benefits. Existing group-based arthritis exercise programs reach only a very small percentage of the population. The overall purpose of this study is to test a self-directed and low-cost multicomponent physical activity program for people with arthritis on outcomes including symptoms of arthritis, lower body strength, functional aerobic capacity, flexibility, physical activity, arthritis self-efficacy and disability, upper body strength, balance, gait, and depressive symptoms. The second primary aim is to evaluate the safety of the physical activity program. The third primary aim is to conduct a process evaluation to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction. Adults aged 18 years and older with arthritis will be recruited from the midlands area of South Carolina. After completion of a baseline visit, participants will be randomized in equal numbers to the 12-week physical activity program (First Step to Active Health®) or the 12-week attention-control group (Steps to Healthy Eating). The attention control intervention will have the same "look and feel" as the physical activity intervention and will require similar activities such as self-monitoring of behavior. Follow-up measurements will take place post-program (12-weeks) and 6 months post-program (i.e., 9 months post-randomization). If First Step to Active Health® is shown to be effective, it could be widely disseminated for a very low cost, thus having the potential to make a tremendous public health impact on the burden of arthritis.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 401 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of South Carolina is the lead sponsor of 191 studies on the registry; 41 are open to participants now.
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This arm is a self-directed, multicomponent, exercise intervention. Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises. Participants also complete a daily log of their exercises and return the logs every week for 12 weeks.
Behavioral: Multicomponent exercise
This arm is a self-directed nutrition intervention. Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans. Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks.
Behavioral: Nutrition
This intervention is a self-directed, multicomponent, exercise intervention. Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises. Participants also complete a daily log of their exercises and return the logs every week for 12 weeks. The active intervention phase is 12 weeks.
This arm is a self-directed nutrition intervention. Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans. Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks. The active intervention lasts for 12 weeks.
Symptoms of arthritis
Visual numeric scales to assess pain, fatigue, and stiffness
Time frame: 12 weeks
Lower body strength
The 30-second chair stand will assess lower body strength.
Time frame: 12 weeks
Functional exercise capacity
The six-minute walk will assess functional exercise capacity
Time frame: 12 weeks
Flexibility
The sit-and-reach test will assess flexibility
Time frame: 12 weeks
Physical activity
The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
Time frame: 12 weeks
Arthritis management self-efficacy
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
Time frame: 12 weeks
Disability
The Health Assessment Questionnaire (HAQ) will assess disability
Time frame: 12 weeks
Upper body strength
The grip strength test (kg/lbs of force) will assess upper body strength
Time frame: 12 weeks
Balance
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
Time frame: 12 weeks
Gait
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
Time frame: 12 weeks
Depressive symptoms
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
Time frame: 12 weeks
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of South Carolina