University of South Carolina Prevention Research Center
Columbia, South Carolina, 29208, United States
NCT Number: NCT01172327
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Columbia, South Carolina, 29208, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks
Visual numeric scales to assess pain, fatigue, and stiffness
Time frame: 12 weeks
The 30-second chair stand will assess lower body strength.
Time frame: 12 weeks
The six-minute walk will assess functional exercise capacity
Time frame: 12 weeks
The sit-and-reach test will assess flexibility
Time frame: 12 weeks
The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
Time frame: 12 weeks
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
Time frame: 12 weeks
The Health Assessment Questionnaire (HAQ) will assess disability
Time frame: 12 weeks
The grip strength test (kg/lbs of force) will assess upper body strength
Time frame: 12 weeks
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
Time frame: 12 weeks
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
Time frame: 12 weeks
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
University of South Carolina
Other
Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis
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.
Published trials that share one or more normalized conditions with this study.
NCT05289544
Arthritis, Arthritis, Rheumatoid
Columbia, South Carolina, United States
View Trial DetailsNCT01867840
Arthritis, Arthritis, Gouty
Nice, France
View Trial DetailsNCT01685424
Ankylosing Spondylitis, Ankylosis
View Trial DetailsNCT01305356
Ankylosis, Arthritis
Tucson, Arizona, United States
View Trial Details