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Completed

NCT Number: NCT01172327

Self-Directed Exercise Program for Adults With Arthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina Prevention Research Center

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multicomponent exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Symptoms of arthritis

    Time frame: 12 weeks

    Visual numeric scales to assess pain, fatigue, and stiffness

  2. Lower body strength

    Time frame: 12 weeks

    The 30-second chair stand will assess lower body strength.

  3. Functional exercise capacity

    Time frame: 12 weeks

    The six-minute walk will assess functional exercise capacity

  4. Flexibility

    Time frame: 12 weeks

    The sit-and-reach test will assess flexibility

  5. Physical activity

    Time frame: 12 weeks

    The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation

  6. Arthritis management self-efficacy

    Time frame: 12 weeks

    The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms

Secondary outcomes

  1. Disability

    Time frame: 12 weeks

    The Health Assessment Questionnaire (HAQ) will assess disability

  2. Upper body strength

    Time frame: 12 weeks

    The grip strength test (kg/lbs of force) will assess upper body strength

  3. Balance

    Time frame: 12 weeks

    Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse

  4. Gait

    Time frame: 12 weeks

    GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity

  5. Depressive symptoms

    Time frame: 12 weeks

    The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2010
Registry last updated
Apr 28, 2021

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.

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