Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? (Prehab-COG)
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Stanford, California, Förenta staterna, 94305
- Stanford Healthcare Centers
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults patients (50 years old or older).
- Scheduled to undergo non-cardiac or non-neurological surgery under general anesthesia.
- Plan to be admitted to the hospital after surgery for a minimum of one night.
- ASA physical status classification I to III.
- English or Spanish fluency (Cognitive testing only validated to be used with English or Spanish speakers).
Exclusion Criteria:
- Not able to understand/speak English or Spanish
- Failure to satisfy adequate hearing test with/without hearing aids.
- Visual impairment.
- Unplanned ICU admission after surgery.
- Patients who are undergoing another intervention study that consists of a cognitive or exercise intervention.
- Inability to provide consistent EEG data of sufficient quality, determined at enrollment.
- 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.
- 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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
|
Feasibility will be measured by:
|
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.
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Cindy Kin, MD, Stanford University
- Huvudutredare: Patrick Purdon, PhD, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 85871
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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