| May 17, 2010 |
| January 14, 2013 |
| September 2009 |
| July 2012 (final data collection date for primary outcome measure) |
- Symptoms of arthritis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Visual numeric scales to assess pain, fatigue, and stiffness
- Lower body strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The 30-second chair stand will assess lower body strength.
- Functional exercise capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The six-minute walk will assess functional exercise capacity
- Flexibility [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The sit-and-reach test will assess flexibility
- Physical activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
- Arthritis management self-efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
|
| Same as current |
| Complete list of historical versions of study NCT01172327 on ClinicalTrials.gov Archive Site |
- Disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The Health Assessment Questionnaire (HAQ) will assess disability
- Upper body strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The grip strength test (kg/lbs of force) will assess upper body strength
- Balance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
- Gait [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
- Depressive symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
|
- Disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The Health Assessment Questionnaire (HAQ) will assess disability
- Upper body strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The grip strength test (kg/lbs of force) will assess upper body strength
- Balance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
- Gait [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
- Depressive symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
- Disability [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The Health Assessment Questionnaire (HAQ) will assess disability
- Upper Body Strength [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The grip strength test (kg/lbs of force) will assess upper body strength
- Balance [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
- Gait [ Time Frame: 9 months ] [ Designated as safety issue: No ]
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
- Depressive symptoms [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
|
| Not Provided |
| Not Provided |
| |
| Self-Directed Exercise Program for Adults With Arthritis |
| Evaluation of a Self-directed, Packaged Physical Activity 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
- Arthritis
- Osteoarthritis
- Rheumatoid Arthritis
- Fibromyalgia
|
- 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.
- Behavioral: 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.
|
- Experimental: Multicomponent exercise
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.
Intervention: Behavioral: Multicomponent exercise
- Active Comparator: 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.
Intervention: Behavioral: Nutrition
|
| Not Provided |
| |
| Completed |
| 401 |
| July 2012 |
| July 2012 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT01172327 |
| CDC-1U48/DP0019361 SIP 09-028 |
| No |
| University of South Carolina |
| University of South Carolina |
| Centers for Disease Control and Prevention |
| Principal Investigator: |
Sara Wilcox, PhD |
University of South Carolina |
|
|
| University of South Carolina |
| January 2013 |