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Improving Resilience and Longevity for Workers Through Exercise

16. November 2017 aktualisiert von: McMaster University
The purpose of this study is to examine the impact of an OA-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip OA as well as those with no joint pain. The investigators hypothesize that exercise designed for OA, delivered at work, will improve all of these outcomes.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The Canadian workforce is aging. The most prevalent age group is 50-54 years and most of these Canadians will aim to continue working over the next 10 years. However, the impact of arthritis on aging Canadians compromises their ability to continue working. By 2031, over 2 million Canadians aged 45 to 64 years will have arthritis. The investigators aim to boost the ability of adults with the most common arthritis, osteoarthritis (OA), as well as adults without OA, to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among workers with knee and hip OA will be of great public health significance in the coming decades. However, the investigators face two challenges. First, obesity among sedentary workers is a risk for worsening knee and hip OA. Second, large occupational loads on the knee and hip worsen OA. Exercise has the most promise in addressing these challenges because it reduces pain and sick time, and improves mental health. Thus, there is a call for studies examining exercise for workers with knee and hip OA.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

43

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Kanada
    • Ontario
      • Hamilton, Ontario, Kanada, L8S4L8
        • McMaster 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

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • full-time or part-time administrative employees

Exclusion Criteria:

  • Any other forms of arthritis
  • Osteoporosis-related fracture
  • History of patellofemoral symptoms
  • Active non-arthritic hip or knee disease
  • Hip or knee surgery
  • Use of cane or walking aid
  • Unstable heart condition
  • Neurological conditions
  • Hip, knee or ankle injuries in past 3 months
  • Physician-advised restriction to physical activity
  • Any injuries that would prohibit participation in exercise
  • Ipsilateral ankle conditions
  • Currently receiving cancer treatment
  • Currently pregnant

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
The participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Sonstiges: Exercise
A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
Sonstiges: No Exercise
The participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.
Sonstiges: No Exercise
A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Lower Extremity Functional Scale
Zeitfenster: Weeks 1 and 13
The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures
Weeks 1 and 13

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Self-reported Knee and Hip Pain
Zeitfenster: Weeks 1 and 13
Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).
Weeks 1 and 13
Change in Self-reported Upper Extremity Pain
Zeitfenster: Weeks 1 and 13
The Disabilities of the Arm Shoulder and Hand is a 30-item questionnaire addressing upper extremity physical function and symptoms. The DASH is suitable for people with any upper limb musculoskeletal disorders and can also monitor changes in severity of symptoms and functional abilities over time. Each item is scored from 1 (no difficulty) to 5 (unable). Total scores range from 0 to 100, with higher scores indicating more upper limb problems.
Weeks 1 and 13
Change in Isometric Knee Extensor and Flexor Strength
Zeitfenster: Weeks 1 and 13
The peak torque developed during knee extension and flexion during a maximum isometric contraction will be measured by use of a ergoFET hand-held dynamometer.
Weeks 1 and 13
Change in Grip Strength
Zeitfenster: Weeks 1 and 13
Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.
Weeks 1 and 13
Change in Cardiovascular Fitness
Zeitfenster: Weeks 1 and 13
Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.
Weeks 1 and 13
Change in Mobility Performance (Six-Minute Walk Test)
Zeitfenster: Weeks 1 and 13
Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.
Weeks 1 and 13
Change in Mobility Performance (Stair Ascent and Descent)
Zeitfenster: Weeks 1 and 13
Mobility performance will be measured using the Stair Ascent and Descent Test. For this test, the time taken to ascend, as well as descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Weeks 1 and 13
Change in Mobility Performance (30-second Chair Stand Test)
Zeitfenster: Weeks 1 and 13
Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.
Weeks 1 and 13
Change in Resilience
Zeitfenster: Weeks 1 and 13
Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.
Weeks 1 and 13
Change in Work Ability
Zeitfenster: Weeks 1 and 13
The Work Ability Index (WAI) is a widely-used self-report questionnaire that evaluates a worker's capacity to perform a job accounting for their physical and mental well-being in addition to the demands of their job. The WAI consists of seven dimensions including current work ability relative to life-time best, work ability related to job demands, number of current physician-diagnosed health conditions, estimated work impairment due to the conditions, sick leave over the past year, own prognosis, and mental resources. Total scores range from 7 to 49 and can fall under one of four classifications: poor work ability that should be restored (7-27), moderate work ability that should be improved (28-36), good work ability that should be supported (37-43), and excellent work ability that should be maintained (44-49). The WAI produces reliable data.
Weeks 1 and 13
Change in Depressive Symptoms
Zeitfenster: Weeks 1 and 13
Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.
Weeks 1 and 13
Change in Arthritis-related Self-Efficacy
Zeitfenster: Weeks 1 and 13
The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.
Weeks 1 and 13

Mitarbeiter und Ermittler

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

Sponsor

McMaster University

Ermittler

  • Hauptermittler: Monica R Maly, PT, PhD, McMaster 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 (Tatsächlich)

8. Februar 2017

Primärer Abschluss (Tatsächlich)

30. Juni 2017

Studienabschluss (Tatsächlich)

30. Juni 2017

Studienanmeldedaten

Zuerst eingereicht

8. Februar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Februar 2017

Zuerst gepostet (Tatsächlich)

10. Februar 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. August 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. November 2017

Zuletzt verifiziert

1. November 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Workplace Exercise

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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