search
Back to results

Self-Directed Exercise Program for Adults With Arthritis

Primary Purpose

Arthritis, Osteoarthritis, Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multicomponent exercise
Nutrition
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Carolina Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multicomponent exercise

Nutrition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Symptoms of arthritis
Visual numeric scales to assess pain, fatigue, and stiffness
Lower body strength
The 30-second chair stand will assess lower body strength.
Functional exercise capacity
The six-minute walk will assess functional exercise capacity
Flexibility
The sit-and-reach test will assess flexibility
Physical activity
The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
Arthritis management self-efficacy
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms

Secondary Outcome Measures

Disability
The Health Assessment Questionnaire (HAQ) will assess disability
Upper body strength
The grip strength test (kg/lbs of force) will assess upper body strength
Balance
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
Gait
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
Depressive symptoms
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms

Full Information

First Posted
May 17, 2010
Last Updated
April 26, 2021
Sponsor
University of South Carolina
Collaborators
Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT01172327
Brief Title
Self-Directed Exercise Program for Adults With Arthritis
Official Title
Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multicomponent exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Multicomponent exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition
Intervention Description
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 Outcome Measure Information:
Title
Symptoms of arthritis
Description
Visual numeric scales to assess pain, fatigue, and stiffness
Time Frame
12 weeks
Title
Lower body strength
Description
The 30-second chair stand will assess lower body strength.
Time Frame
12 weeks
Title
Functional exercise capacity
Description
The six-minute walk will assess functional exercise capacity
Time Frame
12 weeks
Title
Flexibility
Description
The sit-and-reach test will assess flexibility
Time Frame
12 weeks
Title
Physical activity
Description
The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
Time Frame
12 weeks
Title
Arthritis management self-efficacy
Description
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
The Health Assessment Questionnaire (HAQ) will assess disability
Time Frame
12 weeks
Title
Upper body strength
Description
The grip strength test (kg/lbs of force) will assess upper body strength
Time Frame
12 weeks
Title
Balance
Description
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
Time Frame
12 weeks
Title
Gait
Description
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
Time Frame
12 weeks
Title
Depressive symptoms
Description
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Wilcox, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina Prevention Research Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28580795
Citation
Baruth M, Wilcox S, Jake-Schoffman DE, Schlaff RA, Goldufsky TM. Effects of a Self-Directed Nutrition Intervention Among Adults With Chronic Health Conditions. Health Educ Behav. 2018 Feb;45(1):61-67. doi: 10.1177/1090198117709317. Epub 2017 Jun 3.
Results Reference
derived
PubMed Identifier
25441237
Citation
Wilcox S, McClenaghan B, Sharpe PA, Baruth M, Hootman JM, Leith K, Dowda M. The steps to health randomized trial for arthritis: a self-directed exercise versus nutrition control program. Am J Prev Med. 2015 Jan;48(1):1-12. doi: 10.1016/j.amepre.2014.08.006. Epub 2014 Nov 6.
Results Reference
derived
PubMed Identifier
24392226
Citation
Schoffman DE, Wilcox S, Baruth M. Association of body mass index with physical function and health-related quality of life in adults with arthritis. Arthritis. 2013;2013:190868. doi: 10.1155/2013/190868. Epub 2013 Dec 12.
Results Reference
derived

Learn more about this trial

Self-Directed Exercise Program for Adults With Arthritis

We'll reach out to this number within 24 hrs