ElderlyNCT06510088
Effects of Multimodal Prehabilitation on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
A study testing 3-week multimodal prehabilitation program in people with Elderly and Frail, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 1 site in China.
Trial summary
Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly, Frail, Gastric Cancer
- What is being tested?
- 3-week multimodal prehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over the age of 65;
- Patients with a Fried Frailty Index score of 2 or higher;
- Patients who were scheduled for surgical resection of gastric adenocarcinoma;
- Patients whose life expectancy was estimated by the surgeon to be greater than six months -
Who cannot join
- Patients were excluded from the study if they:
- were scheduled for neoadjuvant therapy;
- had metastatic cancer;
- were unable to swallow or participate in exercise and fitness assessments due to pre-existing conditions (e.g., orthopedic, neuromuscular, or cardiorespiratory diseases);
- had low compliance, defined as executing less than 70% of the weekly plan;
- had incomplete data or were lost to follow-up. -
Trial locations and contacts
1 site in 1 country.
China1 site
Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University
Taizhou, Zhejiang
About this study
Official title: Prognostic Impact of a 3-week Multimodal Prehabilitation Program on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation consisting of preoperative physical therapy, nutritional support, and cognitive exercises decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.
Read the detailed description
Gastric cancer remains a significant health concern globally, especially among elderly individuals, where it poses a considerable burden due to its aggressive nature and limited therapeutic options. Population aging, a result of demographic transition, presents a critical societal challenge. According to a 2022 report by the World Health Organization (WHO), the median age for gastric cancer diagnosis is 69 years, with patients over 75 years facing heightened risks of morbidity and mortality. Although surgical resection remains the primary treatment for gastric cancer, the proportion of elderly patients undergoing surgery declines with age due to preoperative frailty. Frailty, marked by age-related declines in energy, muscle strength, weight, and activity levels, is common among elderly gastric cancer patients and correlates with poorer surgical outcomes, including higher morbidity and mortality. Therefore, interventions aimed at enhancing the functional status and resilience of frail elderly patients undergoing surgery for gastric cancer are critically important.
Numerous studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, length of hospital stay (LOS), and care dependence by enhancing functional reserve. However, these studies did not differentiate between age groups and frailty status, making it difficult to interpret the relationship between the outcomes and advanced age or frailty. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, conclusive evidence on multimodal rehabilitation specifically designed for this vulnerable population remains insufficient.
Prehabilitation seeks to optimize patients' preoperative risk factors during the waiting period before surgery. This preoperative phase is a critical time to modify health behaviors to reduce the stress of surgery and enhance the recovery process. Multimodal prehabilitation encompasses various interventions, including physical exercise, nutritional optimization, and psychological support, aiming to bolster physiological reserve in anticipation of the expected adverse effects of surgery and to support the postoperative recovery of functional capacity, particularly in patients with lower preoperative fitness levels. Several studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, LOS, and care dependence by enhancing functional reserve. However, during their research, the patients' age group and frailty status were not differentiated, and the relationship between the results and advanced age/frailty cannot be well interpreted. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, definitive evidence on multimodal rehabilitation specifically tailored to this vulnerable population is lacking.
Therefore, we implemented a randomized clinical trial to provide evidence regarding the potential advantages of multimodal prehabilitation on the outcomes of frail elderly patients undergoing elective gastric cancer surgery.
- Conditions
- Elderly, Frail, Gastric Cancer, Prehabilitation
- Being tested
- 3-week multimodal prehabilitation program
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-week multimodal prehabilitation programProcedure or surgery
This program included four components:
Aerobic and Resistance Exercises A designated physical therapist supervises the resistance exercises and offers corrective guidance. Training intensity was continuously monitored and fine-tuned based on Borg scale assessments.
Respiratory Training Respiratory training was conducted using a respiratory trainer. Patients were instructed to engage in respiratory training at least three times daily, with each session lasting 10 minutes.
Nutrition Intervention Those in the multimodal prehabilitation group received daily whey protein powder to ensure a recommended protein intake of 1.5 g/kg/d. Protein supplements were to be consumed within one hour of exercise to promote muscle synthesis.
Psychological Intervention Anxiety-coping interventions included relaxation techniques and deep breathing exercises, administered in a one-to-one format by a nurse trained in psychological care.
| Study group | Role | What they receive |
|---|---|---|
| 3-week multimodal prehabilitation program+perioperative care guided by ERAS protocols | Experimental | This program included four components: aerobic and resistance exercises, respiratory training, nutritional counseling with whey protein supplementation, and psychological adjustment. Receives: Procedure: 3-week multimodal prehabilitation program |
| perioperative care guided by ERAS protocols | No intervention | Perioperative care of the control group was based on standardized ERAS recommendations that have been widely implemented to minimize heterogeneity in perioperative care. Typically, participants did not receive any preoperative interventions related to exercise, nutrition, or mental health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
30-day postoperative complications assessed by the Comprehensive Complication Index (CCI); The CCI, a validated index for assessing morbidity and mortality, aggregates all complications using the Clavien-Dindo classification system, resulting in a score from 0 (no complications) to 100 (death)
Measured: 30-day after surgery
6-minute walking distance (6MWD)
Functional capacity was assessed using the 6-MWD, a reliable measure of exercise tolerance in patients undergoing colorectal surgery, with changes of at least 20 meters deemed clinically significant.
Measured: 30-day after surgery3-month after surgery
Secondary outcomes (4)
recovery of gastrointestinal function
recovery of gastrointestinal function
Measured: 30 days after surgery
QoL
QoR-9 scale
Measured: 3-month after surgery
physical activity
Short Form (36) health survey (SF-36)
Measured: 3-month after surgery
psychological status
Hospital Anxiety and Depression scale
Measured: 3-month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Mar 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 ElderlyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senbin Lin, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Investigators
- Senbin Lin, Principal investigator, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510088
- Sponsor's protocol ID
- TaizhouHospital
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Hong C, Chen R, Zhou M, Lin S. Prognostic impact of a 3-week multimodal prehabilitation program on frail elderly patients undergoing elective gastric cancer surgery: a randomized trial. BMC Gastroenterol. 2024 Nov 11;24(1):403. doi: 10.1186/s12876-024-03490-7.
PubMed 39528916
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of a 3-week Multimodal Prehabilitation Program on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT06510088
- Acronym / sponsor ID
- TaizhouHospital
- Conditions
- Elderly, Frail, Gastric Cancer, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Jul 2024 (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.
Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation consisting of preoperative physical therapy, nutritional support, and cognitive exercises decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.
Detailed description
Gastric cancer remains a significant health concern globally, especially among elderly individuals, where it poses a considerable burden due to its aggressive nature and limited therapeutic options. Population aging, a result of demographic transition, presents a critical societal challenge. According to a 2022 report by the World Health Organization (WHO), the median age for gastric cancer diagnosis is 69 years, with patients over 75 years facing heightened risks of morbidity and mortality. Although surgical resection remains the primary treatment for gastric cancer, the proportion of elderly patients undergoing surgery declines with age due to preoperative frailty. Frailty, marked by age-related declines in energy, muscle strength, weight, and activity levels, is common among elderly gastric cancer patients and correlates with poorer surgical outcomes, including higher morbidity and mortality. Therefore, interventions aimed at enhancing the functional status and resilience of frail elderly patients undergoing surgery for gastric cancer are critically important.
Numerous studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, length of hospital stay (LOS), and care dependence by enhancing functional reserve. However, these studies did not differentiate between age groups and frailty status, making it difficult to interpret the relationship between the outcomes and advanced age or frailty. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, conclusive evidence on multimodal rehabilitation specifically designed for this vulnerable population remains insufficient.
Prehabilitation seeks to optimize patients' preoperative risk factors during the waiting period before surgery. This preoperative phase is a critical time to modify health behaviors to reduce the stress of surgery and enhance the recovery process. Multimodal prehabilitation encompasses various interventions, including physical exercise, nutritional optimization, and psychological support, aiming to bolster physiological reserve in anticipation of the expected adverse effects of surgery and to support the postoperative recovery of functional capacity, particularly in patients with lower preoperative fitness levels. Several studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, LOS, and care dependence by enhancing functional reserve. However, during their research, the patients' age group and frailty status were not differentiated, and the relationship between the results and advanced age/frailty cannot be well interpreted. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, definitive evidence on multimodal rehabilitation specifically tailored to this vulnerable population is lacking.
Therefore, we implemented a randomized clinical trial to provide evidence regarding the potential advantages of multimodal prehabilitation on the outcomes of frail elderly patients undergoing elective gastric cancer surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-week multimodal prehabilitation program+perioperative care guided by ERAS protocols | Experimental | Procedure: 3-week multimodal prehabilitation programThis program included four components: aerobic and resistance exercises, respiratory training, nutritional counseling with whey protein supplementation, and psychological adjustment. |
| perioperative care guided by ERAS protocols | No intervention | –Perioperative care of the control group was based on standardized ERAS recommendations that have been widely implemented to minimize heterogeneity in perioperative care. Typically, participants did not receive any preoperative interventions related to exercise, nutrition, or mental health. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 65;
- Patients with a Fried Frailty Index score of 2 or higher;
- Patients who were scheduled for surgical resection of gastric adenocarcinoma;
- Patients whose life expectancy was estimated by the surgeon to be greater than six months -
Key exclusion criteria (6 listed)
- were scheduled for neoadjuvant therapy;
- had metastatic cancer;
- were unable to swallow or participate in exercise and fitness assessments due to pre-existing conditions (e.g., orthopedic, neuromuscular, or cardiorespiratory diseases);
- had low compliance, defined as executing less than 70% of the weekly plan;
- had incomplete data or were lost to follow-up. -
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 |
|---|---|---|
| 3-week multimodal prehabilitation programThis program included four components: Aerobic and Resistance Exercises A designated physical therapist supervises the resistance exercises and offers corrective guidance. Training intensity was continuously monitored and fine-tuned based on Borg scale assessments. Respiratory Training Respiratory training was conducted using a respiratory trainer. Patients were instructed to engage in respiratory training at least three times daily, with each session lasting 10 minutes. Nutrition Intervention Those in the multimodal prehabilitation group received daily whey protein powder to ensure a recommended protein intake of 1.5 g/kg/d. Protein supplements were to be consumed within one hour of exercise to promote muscle synthesis. Psychological Intervention Anxiety-coping interventions included relaxation techniques and deep breathing exercises, administered in a one-to-one format by a nurse trained in psychological care. | Procedure or surgery | 3-week multimodal prehabilitation program+perioperative care guided by ERAS protocols |
Primary outcome
postoperative complications
Time frame: 30-day after surgery
30-day postoperative complications assessed by the Comprehensive Complication Index (CCI); The CCI, a validated index for assessing morbidity and mortality, aggregates all complications using the Clavien-Dindo classification system, resulting in a score from 0 (no complications) to 100 (death)
6-minute walking distance (6MWD)
Time frame: 30-day after surgery3-month after surgery
Functional capacity was assessed using the 6-MWD, a reliable measure of exercise tolerance in patients undergoing colorectal surgery, with changes of at least 20 meters deemed clinically significant.
4 secondary outcomes
recovery of gastrointestinal function
Time frame: 30 days after surgery
QoL
Time frame: 3-month after surgery
physical activity
Time frame: 3-month after surgery
psychological status
Time frame: 3-month after 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 19 Jul 2024.
- Derived from this study: PubMed 39528916Chen J, Hong C, Chen R, Zhou M, Lin S. Prognostic impact of a 3-week multimodal prehabilitation program on frail elderly patients undergoing elective gastric cancer surgery: a randomized trial. BMC Gastroenterol. 2024 Nov 11;24(1):403. doi: 10.1186/s12876-024-03490-7.
- Individual participant dataSharing planned: No
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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.
Senbin Lin principal investigator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-week multimodal prehabilitation program in people with Elderly and Frail, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou 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 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 19 Jul 2024. 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?
postoperative complications (time frame: 30-day after surgery). The study lists 2 primary outcomes in all. 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 NCT06510088, 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 19 Jul 2024.