Self-Directed Exercise Program for Adults With Arthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01172327
First received: May 17, 2010
Last updated: January 14, 2013
Last verified: January 2013

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP