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Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA)

10. Oktober 2022 aktualisiert von: Brian Focht, Ohio State University

The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA

The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks.

Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients.

Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients.

Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

227

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • The Ohio State University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
  • Overweight or Obese: BMI >25 and <40
  • Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
  • Sedentary: sedentary lifestyle defined as currently participating < 20 minutes of weekly structured moderate intensity exercise occurring in bouts >10 min
  • Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
  • Age: > 50 years of age
  • Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
  • Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
  • Agreeableness: willing to accept randomization and complete all assessment and intervention procedures

Exclusion Criteria:

  • Health Status: any serious medical condition that precludes safe participation in an exercise program
  • Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Exercise and Dietary Weight Loss
For the first 6 months, participants will meet at a community center for 3 group-based sessions and 1 individual session each month. Sessions include a 45 minute exercise component and a 45 minute dietary weight loss component. Exercise will consist of progressive aerobic and strength training. The dietary component will focus on decreasing caloric intake, while being nutritionally safe. All diets will be monitored by a Registered Dietitian. During months 7-12, participants will meet for 1 group session and 1 individual session per month. The final 12-24 months, bimonthly phone calls are provided to the participants to aid in retention efforts.
Verhalten: Exercise and Dietary Weight Loss
The EX+DWL intervention consists of group and individual exercise sessions, as well as, nutritional and dietary counseling. Bimonthly phone calls are made in the final year of the study to aid in maintenance of the program.
Aktiver Komparator: Walk with Ease
The Arthritis Foundation's (AF) WWE is a self-management program for symptoms of arthritis (pain, fatigue, stiffness,etc.) through exercise. It is a 6 week program involving 3 sessions per week each lasting about 60 minutes. The WWE sessions are comprised of walking, stretching and strengthening exercises, and health education lectures. These group classes will be lead by an AF instructor. Each participant will complete 2 consecutive WWE classes for a total of 12 weeks in the program. During the final week of the program, participants will be trained and transitioin to the self-directed version of WWE for maintenance of exercise. To aid in retention efforts, phone contacts are provided to participants on a monthly basis from 4-12 months and bi-monthly from 12 to 24 months
Verhalten: Walk with Ease
The WWE 6 week program consists of health education lectures on arthritis self-management, a walking exercise portion, and at- home strength exercises. Participants will complete two consecutive WWE programs. Monthly and bimonthly phone calls are made to participants in months 4-12 and 12-24, respectively, to aid in maintenance of the program.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mobility Disability
Zeitfenster: baseline up to 2 years
This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)
baseline up to 2 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anthropometric Battery
Zeitfenster: baseline up to 2 years
Body weight and height are used to calculate Body Mass Index (BMI). Body composition will be assessed using DEXA scans.
baseline up to 2 years
Functional Battery and Limitations
Zeitfenster: baseline up to 2 years
Stair-climb time (SCT) is a functional performance measure that involves ascending and descending a flight of 5 stairs as quickly as possible. Limitations will be assessed using the Pepper Assessment Tool for Disability.
baseline up to 2 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Zeitfenster: baseline up to two years
Scale of 0 (none) to 4 (extreme) indicating the amount of difficulty they have experienced performing basic physical function tasks in the past 48 hours due to knee OA. The physical function subscale consists of 17 items that will be summed to produce a physical function score. Higher scores indicating poorer function
baseline up to two years
Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)
Zeitfenster: baseline up to two years
Health related quality of life survey consisting of mental and physical health with subscales of physical functioning, mental health, role-physical, role-emotional, bodily pain, general health, vitality, and social functioning
baseline up to two years
Dietary intake
Zeitfenster: baseline up to two years
Dietary intake will be assessed by a registered dietician using the Daily food record measure. One weekend and 2 weekdays will be assessed.
baseline up to two years
Social Cognitive Process Measures
Zeitfenster: baseline up to two years
Physical activity barriers self-efficacy scale, Satisfaction with function and appearance scale, Multiple exercise self-regulatory self-efficacy scale, the weight efficacy lifestyle questionnaire (WEL), goal commitment and goal difficulty, arthritis self-efficacy, and pain acceptance.
baseline up to two years
Change in physical activity
Zeitfenster: baseline up to two years
Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer
baseline up to two years
Cost effectiveness
Zeitfenster: baseline up to two years
The cost-effectiveness of the EX+DWL intervention compared to the WWE [program will be calculated as the ratio of additional cost per participant per increment of effectiveness. Effectiveness is based on improvement in the 400 MWT and the Quality of Well-being Scale- Self Administered (to calculate the Quality Adjusted Life Years).
baseline up to two years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ohio State University

Mitarbeiter

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Ermittler

  • Hauptermittler: Brian Focht, PhD, Ohio State University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2016

Primärer Abschluss (Tatsächlich)

1. April 2022

Studienabschluss (Tatsächlich)

1. April 2022

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2016

Zuerst gepostet (Schätzen)

18. Juli 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Oktober 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Oktober 2022

Zuletzt verifiziert

1. Oktober 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2015H0394
  • R01AG050725 (US NIH Stipendium/Vertrag)

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