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Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? (Prehab-COG)

9. november 2026 opdateret af: Cindy Kin, Stanford University

Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? A Pilot Study.

The purpose of this protocol is to evaluate the feasibility and acceptability of a preoperative exercise intervention (Prehabilitation) program, along with intraoperative Electroencephalography (EEG) recordings, and pre and post operative cognitive testing in older patients undergoing a major surgery.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford Healthcare Centers

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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adults patients (50 years old or older).
  2. Scheduled to undergo non-cardiac or non-neurological surgery under general anesthesia.
  3. Plan to be admitted to the hospital after surgery for a minimum of one night.
  4. ASA physical status classification I to III.
  5. English or Spanish fluency (Cognitive testing only validated to be used with English or Spanish speakers).

Exclusion Criteria:

  1. Not able to understand/speak English or Spanish
  2. Failure to satisfy adequate hearing test with/without hearing aids.
  3. Visual impairment.
  4. Unplanned ICU admission after surgery.
  5. Patients who are undergoing another intervention study that consists of a cognitive or exercise intervention.
  6. Inability to provide consistent EEG data of sufficient quality, determined at enrollment.
  7. Subjects with medical conditions including but not limited to: Angina pectoris, Congestive Heart Failure (CHF) that make it dangerous for unsupervised physical activity, cognitive and psychiatric conditions that may affect ability to consent.
  8. Subjects who have contraindications to unsupervised exercise including but not limited to fall risks, movement disorders, and those who are on ambulatory oxygen therapy.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Moderate Exercise Arm

The participants will undergo the virtual exercise intervention 2xweek for 3-4 weeks prior to surgery, and take cognitive testing with non-invasive EEG recordings at 5-point time (the baseline prior to start of the exercise program, at 2-4 days prior to surgery, during the surgery, post-op, and 30-day post surgery). Participants will also be interviewed after the intervention and after surgery to obtain their feedback on their experience with the study procedures.
Adfærdsmæssigt: Tailored exercise program

Eligible participants will receive their exercise program, relevant informational material and training. The exercise program will be tailored to the physical fitness of the participants. The 2xweek virtual sessions take 30 minutes each and include guided exercises at mild-moderate intensity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the feasibility of a preoperative home-based exercise intervention program, with intraoperative EEG recording, and pre and post operative cognitive testing, among older patients undergoing major surgery.
Tidsramme: Maximum 3 months from participant enrollment to end/completion of all study-related tasks.

Feasibility will be measured by:

  1. Proportion of Eligible Patients Approached Who Enrolled (Number of eligible patients who enrolled divided by the number of eligible patients approached)
  2. Proportion of Enrolled Participants Completing All Planned Study Data-Collection Assessments (Number and the percentage of the completion for each of the planned data collection points)
Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
Evaluate the acceptability of a preoperative home-based exercise intervention program, with intraoperative EEG recording, and pre and post operative cognitive testing, among older patients undergoing major surgery.
Tidsramme: Maximum 3 months from participant enrollment to end/completion of all study-related tasks.

Acceptability will be measured by:

1) Aggregated (mean) Score of Surveyed Participants' Rating Across Each Study-Task (Average score of participants' ratings across study tasks, including exercise program, EEG recording and cognitive testing).
Maximum 3 months from participant enrollment to end/completion of all study-related tasks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Efterforskere

  • Studieleder: Cindy Kin, MD, Stanford University
  • Ledende efterforsker: Patrick Purdon, PhD, Stanford University

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 (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

30. september 2026

Først indsendt, der opfyldte QC-kriterier

9. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 85871

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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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 .

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