Obesity &Amp; OverweightNCT07076901
Prehabilitation Strategies for Patients Undergoing Laparoscopic Sleeve Gastrectomy
A study testing Psychological Support, Supervised Exercise Program and Lifestyle and Dietary Modification in people with Obesity &Amp; Overweight, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of prehabilitation strategies in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study compares a group receiving prehabilitation (including exercise, nutritional, and psychological support) with a control group receiving routine care. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- Psychological Support, Supervised Exercise Program and Lifestyle and Dietary Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obesity, defined by a body mass index (BMI) ≥35 kg/m².
- Age between 18 and 50 years.
- Failure of non-surgical weight loss methods.
- Surgical eligibility for LSG based on clinical assessment.
- Willingness to participate in the study and sign an informed consent form.
Who cannot join
- Incomplete clinical data.
- Inability to strictly adhere to dietary instructions.
- Inability to complete follow-up visits.
- Secondary obesity.
- Presence of mental disorders, cognitive impairment, or consciousness disturbance.
- Planned pregnancy within 1 year post-surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Effectiveness of Prehabilitation Strategies in Enhancing Recovery and Postoperative Outcomes in Laparoscopic Sleeve Gastrectomy Patients
This study aims to evaluate the effectiveness of prehabilitation strategies in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study compares a group receiving prehabilitation (including exercise, nutritional, and psychological support) with a control group receiving routine care. The primary goal is to determine if prehabilitation improves postoperative recovery, enhances weight loss, improves quality of life, and reduces complications.
Read the detailed description
Obesity is a significant global health issue, and laparoscopic sleeve gastrectomy (LSG) is a common surgical treatment. However, the procedure is invasive and can cause physical and psychological stress, impacting postoperative recovery. Prehabilitation, a process of enhancing a patient's functional capacity before surgery, has shown promise in various surgical fields. This study investigates a "triad prehabilitation management mode," incorporating psychological intervention, nutritional support, and exercise training for patients undergoing LSG. This prospective, randomized controlled trial enrolled 120 patients assigned to either a prehabilitation group or a control group. The prehabilitation group received a structured program of exercise, nutritional guidance, and psychological support for 5-7 days before surgery, in addition to routine care. The control group received routine care only. The study hypothesizes that the prehabilitation strategy will lead to faster gastrointestinal function recovery, better weight loss outcomes, improved quality of life, and a lower rate of postoperative complications compared to routine care.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- Psychological Support, Supervised Exercise Program, Lifestyle and Dietary Modification, Routine Perioperative Care
- Keywords
- Prehabilitation strategy, laparoscopic sleeve gastrectomy, weight loss outcomes, quality of life, postoperative complications
- Medical subject headings
- Obesity, Overweight, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological SupportBehavioural
A structured psychological intervention aimed at alleviating preoperative anxiety. It included one-on-one counseling, providing detailed information about the surgical procedure, introducing relaxation techniques and music therapy, and sharing success stories from previous patients to boost confidence. Support was provided via phone or WeChat video by a qualified psychological counselor.
Supervised Exercise ProgramBehavioural
A daily guided exercise regimen including two components: 1) General physical conditioning consisting of at least 40 minutes of moderate-intensity aerobic and resistance training (e.g., brisk walking, jogging, cycling). 2) Respiratory function training consisting of abdominal breathing (5 times/hour) and balloon-blowing exercises (10 times/day). Patient adherence was monitored daily via a WeChat group.
Lifestyle and Dietary ModificationBehavioural
Focused on optimizing preoperative habits. Nutritional guidance involved a high-protein, high-vitamin diet with six smaller, frequent meals per day to adapt to post-surgery conditions. Lifestyle guidance included advising smoking and alcohol cessation and ensuring 6-8 hours of sleep per night. Daily dietary and sleep status were reported and monitored via a WeChat group.
Routine Perioperative CareOther
Consisted of standard care practices before, during, and after surgery. Preoperative care included health education and fasting instructions. Intraoperative care included body temperature maintenance and vital signs monitoring. Postoperative care included 12-hour ECG monitoring, gradual reintroduction of a clear liquid diet 24 hours post-surgery, encouragement of early mobilization, and standard nursing for catheters and wounds.
| Study group | Role | What they receive |
|---|---|---|
| Observation Group (Prehabilitation) | Experimental | Participants received a multi-component prehabilitation program for 5-7 days before surgery. The program consisted of structured psychological, exercise, and lifestyle interventions administered by a multidisciplinary team, in addition to routine perioperative care. Receives: Behavioral: Psychological Support; Behavioral: Supervised Exercise Program; Behavioral: Lifestyle and Dietary Modification |
| Control Group (Routine Care) | Active comparator | Participants received standard hospital perioperative care as per institutional protocol, without the specific, structured prehabilitation interventions provided to the observation group. Receives: Other: Routine Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery of bowel motility
Time in days from surgery until the first audible bowel sounds.
Measured: Perioperative
Time to first flatus
Time in hours/days from surgery until the patient's first passage of flatus.
Measured: Perioperative
Time to first bowel movement
Time in days from surgery until the patient's first bowel movement.
Measured: Perioperative
Time to first eating
Time in hours/days from surgery until the patient starts clear liquids.
Measured: Perioperative
Duration of hospital stay
Total length of stay in the hospital, measured in days.
Measured: Perioperative
Secondary outcomes (4)
Change in Body Mass Index (BMI)
Change in BMI (kg/m²) from baseline to 6 months post-surgery.
Measured: Baseline and 6 months post-surgery
Change in Waist Circumference
Change in waist circumference (cm) from baseline to 6 months post-surgery.
Measured: Baseline and 6 months post-surgery
Quality of Life Score
Change in score on the Medical Outcomes Study Short Form 36 (MOS SF-36) Health Survey. The scale assesses eight dimensions, with higher scores indicating better quality of life.
Measured: Baseline and 6 months post-surgery
Incidence of Postoperative Complications
The percentage of patients experiencing complications such as abdominal distention, bleeding, and anastomotic leak.
Measured: Perioperative and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yankai Zhao, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076901
- Sponsor's protocol ID
- 2023S00457
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prehabilitation Strategies in Enhancing Recovery and Postoperative Outcomes in Laparoscopic Sleeve Gastrectomy Patients
- ClinicalTrials.gov ID
- NCT07076901
- Acronym / sponsor ID
- 2023S00457
- Conditions
- Obesity &Amp; Overweight
- Keywords
- Prehabilitation strategy, laparoscopic sleeve gastrectomy, weight loss outcomes, quality of life, postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jul 2025 (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.
This study aims to evaluate the effectiveness of prehabilitation strategies in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study compares a group receiving prehabilitation (including exercise, nutritional, and psychological support) with a control group receiving routine care. The primary goal is to determine if prehabilitation improves postoperative recovery, enhances weight loss, improves quality of life, and reduces complications.
Detailed description
Obesity is a significant global health issue, and laparoscopic sleeve gastrectomy (LSG) is a common surgical treatment. However, the procedure is invasive and can cause physical and psychological stress, impacting postoperative recovery. Prehabilitation, a process of enhancing a patient's functional capacity before surgery, has shown promise in various surgical fields. This study investigates a "triad prehabilitation management mode," incorporating psychological intervention, nutritional support, and exercise training for patients undergoing LSG. This prospective, randomized controlled trial enrolled 120 patients assigned to either a prehabilitation group or a control group. The prehabilitation group received a structured program of exercise, nutritional guidance, and psychological support for 5-7 days before surgery, in addition to routine care. The control group received routine care only. The study hypothesizes that the prehabilitation strategy will lead to faster gastrointestinal function recovery, better weight loss outcomes, improved quality of life, and a lower rate of postoperative complications compared to routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation Group (Prehabilitation) | Experimental | Behavioral: Psychological Support, Behavioral: Supervised Exercise Program, Behavioral: Lifestyle and Dietary ModificationParticipants received a multi-component prehabilitation program for 5-7 days before surgery. The program consisted of structured psychological, exercise, and lifestyle interventions administered by a multidisciplinary team, in addition to routine perioperative care. |
| Control Group (Routine Care) | Active comparator | Other: Routine Perioperative CareParticipants received standard hospital perioperative care as per institutional protocol, without the specific, structured prehabilitation interventions provided to the observation group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Obesity, defined by a body mass index (BMI) ≥35 kg/m².
- Age between 18 and 50 years.
- Failure of non-surgical weight loss methods.
- Surgical eligibility for LSG based on clinical assessment.
- Willingness to participate in the study and sign an informed consent form.
Key exclusion criteria (6 listed)
- Incomplete clinical data.
- Inability to strictly adhere to dietary instructions.
- Inability to complete follow-up visits.
- Secondary obesity.
- Presence of mental disorders, cognitive impairment, or consciousness disturbance.
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 |
|---|---|---|
| Psychological SupportA structured psychological intervention aimed at alleviating preoperative anxiety. It included one-on-one counseling, providing detailed information about the surgical procedure, introducing relaxation techniques and music therapy, and sharing success stories from previous patients to boost confidence. Support was provided via phone or WeChat video by a qualified psychological counselor. | Behavioural | Observation Group (Prehabilitation) |
| Supervised Exercise ProgramA daily guided exercise regimen including two components: 1) General physical conditioning consisting of at least 40 minutes of moderate-intensity aerobic and resistance training (e.g., brisk walking, jogging, cycling). 2) Respiratory function training consisting of abdominal breathing (5 times/hour) and balloon-blowing exercises (10 times/day). Patient adherence was monitored daily via a WeChat group. | Behavioural | Observation Group (Prehabilitation) |
| Lifestyle and Dietary ModificationFocused on optimizing preoperative habits. Nutritional guidance involved a high-protein, high-vitamin diet with six smaller, frequent meals per day to adapt to post-surgery conditions. Lifestyle guidance included advising smoking and alcohol cessation and ensuring 6-8 hours of sleep per night. Daily dietary and sleep status were reported and monitored via a WeChat group. | Behavioural | Observation Group (Prehabilitation) |
| Routine Perioperative CareConsisted of standard care practices before, during, and after surgery. Preoperative care included health education and fasting instructions. Intraoperative care included body temperature maintenance and vital signs monitoring. Postoperative care included 12-hour ECG monitoring, gradual reintroduction of a clear liquid diet 24 hours post-surgery, encouragement of early mobilization, and standard nursing for catheters and wounds. | Other | Control Group (Routine Care) |
Primary outcome
Time to recovery of bowel motility
Time frame: Perioperative
Time in days from surgery until the first audible bowel sounds.
Time to first flatus
Time frame: Perioperative
Time in hours/days from surgery until the patient's first passage of flatus.
Time to first bowel movement
Time frame: Perioperative
Time in days from surgery until the patient's first bowel movement.
Time to first eating
Time frame: Perioperative
Time in hours/days from surgery until the patient starts clear liquids.
Duration of hospital stay
Time frame: Perioperative
Total length of stay in the hospital, measured in days.
4 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and 6 months post-surgery
Change in Waist Circumference
Time frame: Baseline and 6 months post-surgery
Quality of Life Score
Time frame: Baseline and 6 months post-surgery
Incidence of Postoperative Complications
Time frame: Perioperative and 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
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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 Psychological Support, Supervised Exercise Program and Lifestyle and Dietary Modification in people with Obesity &Amp; Overweight, run by The First Hospital of Hebei 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jul 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to recovery of bowel motility (time frame: Perioperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2025.