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The PREPARE for COVID Trial

15 maggio 2020 aggiornato da: 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

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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)

Tipo di studio

Interventistico

Iscrizione (Anticipato)

372

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: Gruppo di controllo
Il gruppo di controllo riceverà un opuscolo con le raccomandazioni dell'Organizzazione Mondiale della Sanità sull'attività fisica per le persone di età pari o superiore a 65 anni, nonché una guida all'alimentazione sana per gli anziani.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-reported disability 90 days after enrollment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mental Health
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Health System - Re-admission
Lasso di tempo: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Health System - Transfer to Long-Term Care
Lasso di tempo: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
COVID-19 test results
Lasso di tempo: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Safety [Adverse Events]
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ottawa Hospital Research Institute

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

15 giugno 2020

Completamento primario (Anticipato)

15 dicembre 2020

Completamento dello studio (Anticipato)

15 settembre 2021

Date di iscrizione allo studio

Primo inviato

15 maggio 2020

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2020

Primo Inserito (Effettivo)

18 maggio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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