NCT04293250

Brief Summary

Recommendation is strong on physical activity (PA) in the prehabilitation of Enhanced Recovery After Surgery (ERAS) for various types of surgeries. The evidence is however weak regarding ERAS protocols. Many studies have showed that physical exercise and PA have hypoalgesic effects on healthy individuals and they have better pain tolerance too. Here the investigators study changes in postoperative pain and postoperative nausea and vomiting for various types of surgical patients after performing preoperative PA at moderate or vigorous intensity Vs non-preoperative PA patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
Last Updated

June 16, 2021

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

January 30, 2020

Last Update Submit

June 11, 2021

Conditions

Keywords

postoperative painPhysical ActivityNon-Physical ActivityEnhanced Recovery After SurgeryPrehabilitation

Outcome Measures

Primary Outcomes (1)

  • The beneficial effect of physical activity on postoperative pain after various types of surgeries

    1. The pain scores different of the physical activity (PA) Vs non-physical activity (non-PA) groups are using the numeric pain rating scale (NRS) with 1 represent no pain and 5 represent the worst possible pain. 2. The severity of postoperative pain will be measured prospectively by using NRS at different postoperative time points (i.e. 1, 4, 7, 10, and 24 hour) for comparing the postoperative pain different between PA and non-PA patients.

    2 years and 6 months

Study Arms (2)

Physical activity group

EXPERIMENTAL

1. Investigators employ the recommendations of the American College of Sport Medicine and the World Health Organization for adults to divide our enrolled patients having moderate-intensity as 30-60 min∙d-1 (≥150 min∙wk-1 ) or vigorous-intensity as 20-60 min∙d-1 (≥75 min∙wk-1) for 6-8 weeks preoperatively. 2. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations. 3. The operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.

Procedure: Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group

non-physical activity group

EXPERIMENTAL

1. No any moderate-intensity or vigorous-intensity physical activity for our enrolled patients preoperatively. 2. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations. 3. Various types of operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.

Procedure: Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group

Interventions

Compare postoperative pain scores for the physical activity Vs non-physical activity group

Physical activity groupnon-physical activity group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥18 y/o
  • Enrolled in-patients
  • Patients are scheduled to undergo various operations.
  • The surgeries are expected to last ≥60 minutes
  • Endotracheal intubation or laryngeal mask inhalation general anesthesia.

You may not qualify if:

  • Patients will transferred to the intensive care unit after operations.
  • American Society of Anesthesiology physical status ≥4
  • poorly controlled diabetic mellitus (HA1c ≥9)
  • prolonged corrected QT interval (male ≥0.45 sec, female ≥0.47 sec)
  • Allergy to any opioids (i.e., morphine, fentanyl, pethidine and others) and nonopioids (i.e., selective or nonselective NSAIDs and acetaminophen)
  • Allergy to dexamethasone, granisetron, droperidol, metoclopramide used for prevention of postoperative nausea and vomiting
  • Deaf or unable to speak/understand Taiwanese or Mandarin
  • Failed to recall or uncertain on how many days/times they had spent doing moderate or vigorous physical activity on recent 6 to 8 weeks before receiving surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar.

    PMID: 29392204BACKGROUND
  • Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

    PMID: 24237004BACKGROUND
  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PMID: 28097305BACKGROUND
  • Milliken D, Schofield N. Understanding Prehabilitation. Anaesthesia 2018; Tutorial Of The Week 394: 1-5.

    BACKGROUND
  • Jones MD, Booth J, Taylor JL, Barry BK. Aerobic training increases pain tolerance in healthy individuals. Med Sci Sports Exerc. 2014 Aug;46(8):1640-7. doi: 10.1249/MSS.0000000000000273.

    PMID: 24504426BACKGROUND
  • Naugle KM, Riley JL 3rd. Self-reported physical activity predicts pain inhibitory and facilitatory function. Med Sci Sports Exerc. 2014 Mar;46(3):622-9. doi: 10.1249/MSS.0b013e3182a69cf1.

    PMID: 23899890BACKGROUND
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PMID: 16367493BACKGROUND
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND
  • Hu L, Bentler PM. Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Structural Equation Modeling 1999; 6(1): 1-55

    BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeMotor Activity

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBehavior

Study Officials

  • Wui-Chiu Mui, M.D., MBA

    Chiayi Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: latent growth modeling using structural equation model,
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

March 3, 2020

Study Start

July 1, 2015

Primary Completion

June 30, 2016

Study Completion

December 31, 2017

Last Updated

June 16, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share