Clinical trial NCT04964856: Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty
Official title: Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty of Patients Undergoing Elective Surgery:a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERAS
Frailty
Keywords: ERAS
Frailty
Exercise
Activity
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frailty status
timeFrame: Change from Baseline Fried's Frailty Phenotype scores at 30 days postoperatively
Secondary outcomes:
measure: Change in gait speed
timeFrame: baseline, at 30 days postoperatively
measure: Handgrip strength
timeFrame: baseline, at 30 days postoperatively
measure: Perioperative functional capacity
timeFrame: baseline, at 30 days postoperatively
measure: Patient mood state
timeFrame: baseline and 7th day postoperatively
measure: Nutritional status
timeFrame: baseline, at 30 days postoperatively
measure: Short-term recovery quality
timeFrame: baseline, 1st, 2nd, 3rd and 7th day postoperatively
measure: Postoperative Complications
timeFrame: 30 days postoperatively
measure: Postoperative 30-day mortality
timeFrame: 30 days postoperatively
measure: Highest VAS Pain Score at Rest
timeFrame: baseline, 1st, 2nd, 3rd and 7th day postoperatively
measure: Highest VAS Pain Score during Exercise
timeFrame: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: