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
  Purpose

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.


Condition Intervention Phase
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Fibromyalgia
Behavioral: Multicomponent exercise
Behavioral: Nutrition
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 401
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172327

Locations
United States, South Carolina
University of South Carolina Prevention Research Center
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Sara Wilcox, PhD University of South Carolina
  More Information

No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01172327     History of Changes
Other Study ID Numbers: CDC-1U48/DP0019361 SIP 09-028
Study First Received: May 17, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Fibromyalgia
Myofascial Pain Syndromes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014