Clinical trial NCT01172327: Self-Directed Exercise Program for Adults With Arthritis
Official title: Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Osteoarthritis
Rheumatoid Arthritis
Fibromyalgia
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-07-29
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Self-reported, health care provider-diagnosed arthritis (CDC definition)
* 18+ years of age
* Self-reported symptoms of joint pain, stiffness, tenderness, decreased range of motion, redness and warmth, deformity, crackling or grating, or fatigue
* Able to read and write in English

Exclusion Criteria:

* Another member of household is participating in study
* Plans to move from the Columbia, SC area in the next 9 months
* Unable to walk longer than 3 minutes without taking a rest
* Unable to stand without assistance for more than 2 minutes
* Cannot sit in a chair without arms for more than 5 minutes
* Measured resting blood pressure \>160/100
* Positive response to PAR-Q question(s)
* Had a fall in the past year that required medical assistance
* Pregnant or breastfeeding
* Uses insulin to manage diabetes
* Participating in another research study that includes an intervention or drug
* Participates in 3+ days of structured moderate-intensity exercise for 30+ minutes per day
* Participates in 2+ days of strength building exercises for 20+ minutes per day

Primary outcomes:
measure: Symptoms of arthritis
timeFrame: 12 weeks
measure: Lower body strength
timeFrame: 12 weeks
measure: Functional exercise capacity
timeFrame: 12 weeks
measure: Flexibility
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Arthritis management self-efficacy
timeFrame: 12 weeks
Secondary outcomes:
measure: Disability
timeFrame: 12 weeks
measure: Upper body strength
timeFrame: 12 weeks
measure: Balance
timeFrame: 12 weeks
measure: Gait
timeFrame: 12 weeks
measure: Depressive symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Prevention Research Center
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Sara Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baruth M, Wilcox S, Jake-Schoffman DE, Schlaff RA, Goldufsky TM. Effects of a Self-Directed Nutrition Intervention Among Adults With Chronic Health Conditions. Health Educ Behav. 2018 Feb;45(1):61-67. doi: 10.1177/1090198117709317. Epub 2017 Jun 3.
citation: Wilcox S, McClenaghan B, Sharpe PA, Baruth M, Hootman JM, Leith K, Dowda M. The steps to health randomized trial for arthritis: a self-directed exercise versus nutrition control program. Am J Prev Med. 2015 Jan;48(1):1-12. doi: 10.1016/j.amepre.2014.08.006. Epub 2014 Nov 6.
citation: Schoffman DE, Wilcox S, Baruth M. Association of body mass index with physical function and health-related quality of life in adults with arthritis. Arthritis. 2013;2013:190868. doi: 10.1155/2013/190868. Epub 2013 Dec 12.