Self-Directed Exercise Program for Adults With Arthritis - Full Text View

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:

MedlinePlus related topics: Exercise and Physical Fitness Fibromyalgia Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

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.

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

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

Centers for Disease Control and Prevention

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
Fibromyalgia
Myofascial Pain Syndromes
Osteoarthritis
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 June 18, 2013