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The PREPARE for COVID Trial

15. Mai 2020 aktualisiert von: Ottawa Hospital Research Institute

PRomoting Exercise During the Pandemic to Increase Activity and Reduce Effects of Social Isolation for COVID: The PREPARE for COVID Trial

This is a randomized trial of home-based exercises versus control for older adults during the COVID-19 pandemic. The hypothesis is that participation in a home-based program will reduce the risk of adverse effects of physical distancing by decreasing patient-reported disability, improving mental health and avoiding hospitalization or institutionalization for vulnerable older people

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Background:More than 6.5 million Canadians are > 65 years of age. Over half of older Canadians live with multiple comorbidities, leaving them at high risk of adverse outcomes of COVID-19. Social isolation and physical distancing orders are especially important to protect the health of this high-risk population. Vulnerable older Canadians are also at high risk of physical and mental health deterioration caused by the physical distancing meant to protect them from COVID-19. Effective management of the COVID-19 pandemic and its consequences will require evidence-based strategies to support isolated vulnerable older Canadians. Exercise interventions can reduce the adverse health effects of social isolation and demonstrate larger effect sizes in older people with comorbidities. However, no exercise interventions have been tested in an acute isolation scenario such as the COVID-19 pandemic, which also requires that exercise interventions be home-based and remotely supported, presenting unique challenges to participation and adherence.

Our team is uniquely positioned re-orient proven and robust programming, supported by a national network of investigators and existing infrastructure. We can immediately launch a large-scale trial to test the effectiveness of a remotely supported home exercise program (designed in partnership with vulnerable older Canadians) to mitigate the negative consequences of physical distancing to keep older Canadians healthy and safe from COVID-19. We hypothesize that participation in the PREPARE program will decrease the individual, health system and population health impacts of COVID19 induced physical distancing and social isolation.

Research aims:Estimate the effectiveness of a remotely supported, home-based multimodal exercise program for older people with multiple comorbidities to improve our primary outcome: patient-reported disability 90-days after enrollment; secondary outcomes: patient-centered (depression, anxiety, quality of life, frailty, survival, 1-year disability scores, COVID19 severity) and system-relevant (admissions, emergency visits, institutionalization, costs, cost-effectiveness).

Methods: Design, setting and participants: Parallel-arm multicenter randomized controlled trial at 3 Canadian hospitals. People >65 years old recently discharged home with >2 comorbidities will be included. Intervention: Three month supported home-based exercise program with demonstrated efficacy, feasibility and acceptability for vulnerable older people.

Outcomes and sample size: We will have 90% power to detect a clinically important difference of in our primary outcome (validated WHODAS tool, 90-days post-enrollment) with 372 participants (186/arm)

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

372

Phase

  • Unzutreffend

Kontakte und Standorte

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

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

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 65 years of age or older
  • 2 or more co-morbidities
  • recent discharge from hospital

Exclusion Criteria:

  • Inability to communicate in English or in French
  • Unreachable by telephone
  • Unstable cardiovascular or valvular disease
  • Discharged to Long-Term Care

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Exercise Group

The home-based exercise program called the PREPARE program.

Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility.
Verhalten: The PREPARE program

A home-based exercise program guided by paper materials, weekly phone calls, and a DVD.

Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility.
Kein Eingriff: Kontrollgruppe
Die Kontrollgruppe erhält die Broschüre mit den Empfehlungen der Weltgesundheitsorganisation zu körperlicher Aktivität für Menschen ab 65 Jahren sowie einen Leitfaden für gesunde Ernährung für ältere Erwachsene.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient-reported disability 90 days after enrollment
Zeitfenster: Assessing change in score from baseline data collection to 90 days from enrollment
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used . It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society. Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.
Assessing change in score from baseline data collection to 90 days from enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mental Health
Zeitfenster: Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
The Patient Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) are validated tools for diagnosing anxiety and depression.
Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
Function
Zeitfenster: Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
Step count using pedometer
Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
Health-related quality of life
Zeitfenster: Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
The EQ-5D-5L is a validated instrument with Canadian valuation statistics and national use, which informs incremental cost per quality-adjusted life year gained.
Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
Frailty
Zeitfenster: Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
The Clinical Frailty Scale (CFS) provides a global assessment of frailty.
Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
All-cause mortality.
Zeitfenster: From enrollment to 12 months after enrollment.
All deaths and death dates will be identified via chart review or telephone call.
From enrollment to 12 months after enrollment.
Health System - Emergency Department Visits
Zeitfenster: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Health System - Re-admission
Zeitfenster: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Health System - Transfer to Long-Term Care
Zeitfenster: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
COVID-19 test results
Zeitfenster: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Safety [Adverse Events]
Zeitfenster: Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.
Falls, cardiac or respiratory complications and unplanned healthcare encounters will be collected during the exercise treatment period for the exercise group. For the control group, participants will be asked if they experienced any falls since the time of enrollment up until the day before surgery. Unplanned healthcare encounters will also be collected during the time of enrollment to the final day of the exercise intervention for the intervention group through chart review.
Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.

Mitarbeiter und Ermittler

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

Sponsor

Ottawa Hospital Research Institute

Ermittler

  • Hauptermittler: Daniel I McIsaac, MD, The Ottawa Hospital Research Institute

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 (Voraussichtlich)

15. Juni 2020

Primärer Abschluss (Voraussichtlich)

15. Dezember 2020

Studienabschluss (Voraussichtlich)

15. September 2021

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Mai 2020

Zuerst gepostet (Tatsächlich)

18. Mai 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Mai 2020

Zuletzt verifiziert

1. Mai 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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