Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty

NCT04964856 | Unknown

• 1 other identifier: CYYYMZK-E
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled, clinical trial on the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery Objective to evaluate the efficacy of ERAS exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery Participants: Patients undergoing elective laparoscopic colorectal surgery over 18 years old. The research intervention was ERAS exercise The study design was a randomized, parallel controlled trial ERAS exercise in perioperative period as the experimental group. No ERAS exercise group was the control group. The sample size was estimated according to the main efficacy index ( the attenuation of frailty after 7 days surgery) of this study. It was assumed that the attenuation of frailty in the ERAS exercise group was better than that of the control group. The parameters were set as test level (alpha) of 0.050 using a two-sided two-sample unequal-variance t-test, β = 0.9, according to the results of previous clinical trials and combined with literature, the population mean difference was 0.6 with standard deviations of 0.8 for the experimental group and 0.8 for the control group. the experimental group: the control group was 1:1, 39 cases in each group, considering the 20% shedding rate, 49 cases in the experimental group and 49 cases in the control group were selected.

1. 1.The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation.
2. 2.The control group The patients do not take ERAS exercise in perioperative period.
3. 3.The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery.
4. 4.Secondary endpoints included the 6-minute walk test (6MWT),nutritional risk screening (NRS2002), anxious and depressive states, activities of daily living (ADL),postoperative complications and mortality,short-term recovery quality,postoperative pain.

Conditions

ERAS; Frailty

Keywords

ERAS; Frailty; Exercise; Activity

Outcome Measures

Primary Outcomes (1)

• Frailty status

  Frailty status (i.e. robust, prefrail or frail) measured using the Fried's Frailty Phenotype (FP) scores. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health status.

  Change from Baseline Fried's Frailty Phenotype scores at 30 days postoperatively

Secondary Outcomes (10)

• Change in gait speed

  baseline, at 30 days postoperatively

• Handgrip strength

  baseline, at 30 days postoperatively

• Perioperative functional capacity

  baseline, at 30 days postoperatively

• Patient mood state

  baseline and 7th day postoperatively

• Nutritional status

  baseline, at 30 days postoperatively

Study Arms (2)

ERAS exercise in perioperative period.

EXPERIMENTAL

The patients take ERAS exercise from hospitalization to 30 days after operation.

Behavioral: ERAS exercise

No ERAS exercise in perioperative period.

SHAM COMPARATOR

The patients do not take ERAS exercise in perioperative period.

Behavioral: No ERAS exercise

Interventions

ERAS exercise BEHAVIORAL

Take ERAS exercise twice a day from hospitalization to 30 days after surgery

ERAS exercise in perioperative period.

No ERAS exercise BEHAVIORAL

Don't take ERAS exercise in perioperative period

No ERAS exercise in perioperative period.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving elective laparoscopic colorectal surgery.
• ≤age≤100 years old, no gender limit;
• The ASA score is between I and Ⅲ;
• Clearly understand and voluntarily participate in the study, and sign an informed consent form.

You may not qualify if:

• Emergency surgery;
• Those with a history of cognitive dysfunction;
• Those with a history of neuromuscular diseases,;
• American Society of Anesthesiologists class ⩾IV;
• Those with a history of spontaneous pneumothorax, coagulation dysfunction,
• Acute and systemic infectious diseases, moderate or higher fever;
• Pregnant women;
• History of drug abuse;
• Those who judged by the physician in charge to be unsuitable for ERAS-exercise;
• Other severe cardio-pulmonary diseases that would affect the 6MWD
• Those failure to obtain informed consent.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (1)

• Yang F, Yuan Y, Liu W, Tang C, He F, Chen D, Xiong J, Huang G, Qian K. Effect of prehabilitation exercises on postoperative frailty in patients undergoing laparoscopic colorectal cancer surgery. Front Oncol. 2024 Sep 12;14:1411353. doi: 10.3389/fonc.2024.1411353. eCollection 2024.

  PMID: 39328202 DERIVED

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: July 16, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

CN (1)