ArthritisNCT01172327
Self-Directed Exercise Program for Adults With Arthritis
A study testing Multicomponent exercise and Nutrition in people with Arthritis and Osteoarthritis, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Multicomponent exercise and Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Prevention Research Center
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis, Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia
- Being tested
- Multicomponent exercise, Nutrition
- Medical subject headings
- Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exerciseBehavioural
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.
NutritionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise | Experimental | 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. Receives: Behavioral: Multicomponent exercise |
| Nutrition | Active comparator | 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. Receives: Behavioral: Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of arthritis
Visual numeric scales to assess pain, fatigue, and stiffness
Measured: 12 weeks
Lower body strength
The 30-second chair stand will assess lower body strength.
Measured: 12 weeks
Functional exercise capacity
The six-minute walk will assess functional exercise capacity
Measured: 12 weeks
Flexibility
The sit-and-reach test will assess flexibility
Measured: 12 weeks
Physical activity
The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
Measured: 12 weeks
Arthritis management self-efficacy
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
Measured: 12 weeks
Secondary outcomes (5)
Disability
The Health Assessment Questionnaire (HAQ) will assess disability
Measured: 12 weeks
Upper body strength
The grip strength test (kg/lbs of force) will assess upper body strength
Measured: 12 weeks
Balance
Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
Measured: 12 weeks
Gait
GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
Measured: 12 weeks
Depressive symptoms
The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Sara Wilcox, University of South Carolina
- Investigators
- Sara Wilcox, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172327
- Sponsor's protocol ID
- Pro00004658
- Status last verified
- Apr 2021
- First submitted
- 17 May 2010
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28580795Wilcox 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.
PubMed 25441237Schoffman 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.
PubMed 24392226
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis
- ClinicalTrials.gov ID
- NCT01172327
- Acronym / sponsor ID
- Pro00004658
- Conditions
- Arthritis, Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise | Experimental | Behavioral: Multicomponent exerciseThis 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. |
| Nutrition | Active comparator | Behavioral: NutritionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent exerciseThis 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. | Behavioural | Multicomponent exercise |
| NutritionThis 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. | Behavioural | Nutrition |
Primary outcome
Symptoms of arthritis
Time frame: 12 weeks
Visual numeric scales to assess pain, fatigue, and stiffness
Lower body strength
Time frame: 12 weeks
The 30-second chair stand will assess lower body strength.
Functional exercise capacity
Time frame: 12 weeks
The six-minute walk will assess functional exercise capacity
Flexibility
Time frame: 12 weeks
The sit-and-reach test will assess flexibility
Physical activity
Time frame: 12 weeks
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
The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
5 secondary outcomes
Disability
Time frame: 12 weeks
Upper body strength
Time frame: 12 weeks
Balance
Time frame: 12 weeks
Gait
Time frame: 12 weeks
Depressive symptoms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 28580795Baruth 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.
- Derived from this study: PubMed 25441237Wilcox 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.
- Derived from this study: PubMed 24392226Schoffman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Wilcox, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise and Nutrition in people with Arthritis and Osteoarthritis, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of arthritis (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172327, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.