ERASEEIPFNCT04964856
Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty
A study testing ERAS exercise and No ERAS exercise in people with ERAS and Frailty, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- ERAS exercise and No ERAS exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty of Patients Undergoing Elective Surgery:a Randomized Controlled Clinical Trial
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
Read more
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.
- The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation.
- The control group The patients do not take ERAS exercise in perioperative period.
Efficacy evaluation
- The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery.
- 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.
- Being tested
- ERAS exercise, No ERAS exercise
- Keywords
- ERAS, Frailty, Exercise, Activity
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS exerciseBehavioural
Take ERAS exercise twice a day from hospitalization to 30 days after surgery
No ERAS exerciseBehavioural
Don't take ERAS exercise in perioperative period
| Study group | Role | What they receive |
|---|---|---|
| ERAS exercise in perioperative period. | Experimental | The patients take ERAS exercise from hospitalization to 30 days after operation. Receives: Behavioral: ERAS exercise |
| No ERAS exercise in perioperative period. | Sham comparator | The patients do not take ERAS exercise in perioperative period. Receives: Behavioral: No ERAS exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Fried's Frailty Phenotype scores at 30 days postoperatively
Secondary outcomes (10)
Change in gait speed
This outcome will be measured using the 5-meter walk test.
Measured: baseline, at 30 days postoperatively
Handgrip strength
Handgrip strength will be measured using a dynamometer.
Measured: baseline, at 30 days postoperatively
Perioperative functional capacity
The 6-minute walk distance (6MWD) test is a non-encouraged test performed in a 30 meters long flat corridor, where the participant is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Ambulation was assessed via the 6MWD test following standardized procedures by measuring the 6MWD in meters. Participants were not permitted to use assistive devices (walker, long leg braces, or short leg braces) during the 6MWD test. Participants with confirmed loss of ambulation at a particular visit were assigned a 6MWD result of 0.
Measured: baseline, at 30 days postoperatively
Patient mood state
This outcome will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Measured: baseline and 7th day postoperatively
Nutritional status
This outcome will be assessed using Nutritional Risk Screening 2002 (NRS-2002): The patients were classified as being nutritionally risk (NRS+): total score ≥ 3 or nutritionally risk-free (NRS-): total score < 3 according to NRS 2002 results.
Measured: baseline, at 30 days postoperatively
Short-term recovery quality
This outcome will be measured using 9-item quality of recovery(QoR-9) score.The QoR-9 is a 9-item score evaluating both physical and mental well-being by assessing five dimensions: emotional state, physical comfort, psychological support, physical independence and pain. Each of the 9 items are scored by the patient from 0 (worst score) to 2 (best score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 18 (best outcome).
Measured: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Postoperative Complications
Postoperative Complications evaluated by Clavien- Dindo Score.Nine domains are evaluated: Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).
Measured: 30 days postoperatively
Postoperative 30-day mortality
Rate of Mortality among study patients
Measured: 30 days postoperatively
Highest VAS Pain Score at Rest
Post-operative pain scores at rest, as assessed by Visual Analog Pain Scale (VAS) will be the primary outcome measured. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
Measured: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Highest VAS Pain Score during Exercise
Post-operative pain scores during Exercise, as assessed by Visual Analog Pain Scale (VAS) will be the primary outcome measured. Postoperative pain during Exerciset will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).
Measured: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 May 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964856
- Sponsor's protocol ID
- CYYYMZK-E
- Acronym
- EEIPF
- Status last verified
- Jul 2021
- First submitted
- 19 Mar 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39328202
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Exercise Improve Perioperative Frailty of Patients Undergoing Elective Surgery:a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04964856
- Acronym / sponsor ID
- EEIPF / CYYYMZK-E
- Keywords
- ERAS, Frailty, Exercise, Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The experimental group The patients take ERAS exercise from hospitalization to 30 days after operation.
- The control group The patients do not take ERAS exercise in perioperative period.
Efficacy evaluation
- The primary endpoint of the study was the attenuation of frailty via Frailty Phenotype (FP) between before surgery and 7days, 30 days after surgery.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS exercise in perioperative period. | Experimental | Behavioral: ERAS exerciseThe patients take ERAS exercise from hospitalization to 30 days after operation. |
| No ERAS exercise in perioperative period. | Sham comparator | Behavioral: No ERAS exerciseThe patients do not take ERAS exercise in perioperative period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS exerciseTake ERAS exercise twice a day from hospitalization to 30 days after surgery | Behavioural | ERAS exercise in perioperative period. |
| No ERAS exerciseDon't take ERAS exercise in perioperative period | Behavioural | No ERAS exercise in perioperative period. |
Primary outcome
Frailty status
Time frame: Change from Baseline Fried's Frailty Phenotype scores at 30 days postoperatively
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.
10 secondary outcomes
Change in gait speed
Time frame: baseline, at 30 days postoperatively
Handgrip strength
Time frame: baseline, at 30 days postoperatively
Perioperative functional capacity
Time frame: baseline, at 30 days postoperatively
Patient mood state
Time frame: baseline and 7th day postoperatively
Nutritional status
Time frame: baseline, at 30 days postoperatively
Short-term recovery quality
Time frame: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Postoperative Complications
Time frame: 30 days postoperatively
Postoperative 30-day mortality
Time frame: 30 days postoperatively
Highest VAS Pain Score at Rest
Time frame: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Highest VAS Pain Score during Exercise
Time frame: baseline, 1st, 2nd, 3rd and 7th day postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 39328202Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS exercise and No ERAS exercise in people with ERAS and Frailty, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty status (time frame: Change from Baseline Fried's Frailty Phenotype scores at 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04964856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.