Self-Directed Exercise Program for Adults With Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172327
• Other study ID #: Pro00004658
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Fibromyalgia
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• Multicomponent exercise
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.
• Nutrition
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.

Locations

Country	Name	City	State
United States	University of South Carolina Prevention Research Center	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of arthritis	Visual numeric scales to assess pain, fatigue, and stiffness	12 weeks
Primary	Lower body strength	The 30-second chair stand will assess lower body strength.	12 weeks
Primary	Functional exercise capacity	The six-minute walk will assess functional exercise capacity	12 weeks
Primary	Flexibility	The sit-and-reach test will assess flexibility	12 weeks
Primary	Physical activity	The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation	12 weeks
Primary	Arthritis management self-efficacy	The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms	12 weeks
Secondary	Disability	The Health Assessment Questionnaire (HAQ) will assess disability	12 weeks
Secondary	Upper body strength	The grip strength test (kg/lbs of force) will assess upper body strength	12 weeks
Secondary	Balance	Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse	12 weeks
Secondary	Gait	GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity	12 weeks
Secondary	Depressive symptoms	The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms	12 weeks