- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01172327
Self-Directed Exercise Program for Adults With Arthritis
26. april 2021 opdateret af: Sara Wilcox, University of South Carolina
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
401
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29208
- University of South Carolina Prevention Research Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Aktiv komparator: 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.
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Symptoms of arthritis
Tidsramme: 12 weeks
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Visual numeric scales to assess pain, fatigue, and stiffness
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12 weeks
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Lower body strength
Tidsramme: 12 weeks
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The 30-second chair stand will assess lower body strength.
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12 weeks
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Functional exercise capacity
Tidsramme: 12 weeks
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The six-minute walk will assess functional exercise capacity
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12 weeks
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Flexibility
Tidsramme: 12 weeks
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The sit-and-reach test will assess flexibility
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12 weeks
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Physical activity
Tidsramme: 12 weeks
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The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
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12 weeks
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Arthritis management self-efficacy
Tidsramme: 12 weeks
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The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Disability
Tidsramme: 12 weeks
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The Health Assessment Questionnaire (HAQ) will assess disability
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12 weeks
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Upper body strength
Tidsramme: 12 weeks
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The grip strength test (kg/lbs of force) will assess upper body strength
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12 weeks
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Balance
Tidsramme: 12 weeks
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Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
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12 weeks
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Gait
Tidsramme: 12 weeks
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GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
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12 weeks
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Depressive symptoms
Tidsramme: 12 weeks
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The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
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12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sara Wilcox, PhD, University of South Carolina
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2009
Primær færdiggørelse (Faktiske)
1. juli 2012
Studieafslutning (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først indsendt
17. maj 2010
Først indsendt, der opfyldte QC-kriterier
28. juli 2010
Først opslået (Skøn)
29. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00004658
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Gigt
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University of AarhusAarhus University HospitalAfsluttetPolyartikulær juvenil reumatoid arthritis | Systemisk juvenil idiopatisk arthritis | Juvenil Idiopatisk Arthritis, OligoarthritisDanmark
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University of Sao Paulo General HospitalIkke rekrutterer endnuJuvenil idiopatisk arthritis | Juvenil reumatoid arthritis | Juvenil arthritisBrasilien
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Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoAfsluttet
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DePuy OrthopaedicsAfsluttetSlidgigt | Rheumatoid arthritis | Avaskulær nekrose | Juvenil reumatoid arthritis | Post-traumatisk arthritis | Anden inflammatorisk arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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NovartisAfsluttetArthritis, Juvenil ReumatoidItalien
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Centocor, Inc.Afsluttet
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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GeneScience Pharmaceuticals Co., Ltd.Ikke rekrutterer endnuAktiv systemisk juvenil idiopatisk arthritisKina
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Institut National de la Santé Et de la Recherche...AfsluttetSystemisk opstået juvenil idiopatisk arthritisFrankrig
Kliniske forsøg med Multicomponent exercise
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Brown UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereIkke rekrutterer endnuKost, sundForenede Stater
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City University of New York, School of Public HealthHanoi University of Public HealthRekruttering