Self-Directed Exercise Program for Adults With Arthritis

University of South Carolina

Status: Completed

Conditions: Fibromyalgia; Osteoarthritis; Arthritis; Rheumatoid Arthritis

Treatments: Behavioral: Nutrition; Behavioral: Multicomponent exercise

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01172327

Pro00004658

Details and patient eligibility

About

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.

Full 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.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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401 participants in 2 patient groups

Multicomponent exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Multicomponent exercise

Nutrition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nutrition