Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty (EEIPF)

Chongqing Medical University

Status: Unknown

Conditions: ERAS; Frailty

Treatments: Behavioral: No ERAS exercise; Behavioral: ERAS exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04964856

CYYYMZK-E

Details and patient eligibility

About

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. The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation.
2. The control group The patients do not take ERAS exercise in perioperative period.

Efficacy evaluation

1. The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery.
2. 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving elective laparoscopic colorectal surgery.
• 18≤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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

ERAS exercise in perioperative period.

Experimental group

Description:

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

Treatment:

Behavioral: ERAS exercise

No ERAS exercise in perioperative period.

Sham Comparator group

Description:

The patients do not take ERAS exercise in perioperative period.

Treatment:

Behavioral: No ERAS exercise