SurgeryNCT06518369
Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting
An observational study of Surgery, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Prehabilitation
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 4 Jun 2025
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects over age 60 who require elective major abdominal surgery
Who may be able to join
- Subjects over age 60 who require elective major abdominal surgery
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of a Preoperative Prehabilitation Program Among Rural Geriatric Patients Compared to Standard of Care
The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.
Read the detailed description
The study will include patients who require elective major abdominal surgery. The study will compare patients who received standard of care to patients who received a prehabilitation program before surgery.
The prehabilitation program will take place for 4-6 weeks before your surgery and will include:
- Review of frailty risk analysis calculator score obtained in the frailty study (#2212-74)
- Review of lab results including complete blood count, creatinine, albumin, and prealbumin
- Review of chronic conditions
- An office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.
- Drinking Surgery Immunonutrition shake twice daily for 5 days before surgery.
- Educational information and video instruction
- Weekly phone calls to motivate, ensure adherence, and assess progress.
- Measurements of hand grip strength and body weight
- Conditions
- Surgery
- Being tested
- Prehabilitation
- Keywords
- Frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Prehabilitation program for 4-6 weeks before surgery will include:
- Review of the frailty risk analysis calculator score obtained in the frailty study (#2212-74)
- Review of lab results including complete blood count, creatinine, albumin, and prealbumin
- Review of chronic conditions.
- An office visit or telehealth visit to review instructions on instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.
- Drinking surgery immunonutrition drinks twice daily for 5 days before surgery.
- Educational information and video instruction
- Weekly phone calls to motivate, ensure adherence, and assess progress.
- Measurements of hand grip strength and body weight
| Study group | Role | What they receive |
|---|---|---|
| Non-intervention or standard of care group | 20 Patients who received standard of care | |
| Prehabilitation Group | 10 patients who take part in a prehabilitation program for 4-6 weeks before surgery Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital length of stay
Number of days in hospital from date of surgery to date of discharge
Measured: From date of hospitalization until date of hospital discharge, up to 30 days
Discharge disposition
Binary measure of either home or rehabilitation facility
Measured: From date of hospitalization until date of hospital discharge, up to 30 days
Secondary outcomes (2)
Adverse outcomes after surgery
Assess adverse outcomes postoperatively
Measured: 30 days after surgery
Hospital readmission rates
Number of times patients are readmitted to the hospital within 30 day of surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start18 Jun 2024
- Primary completion16 Oct 2024
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Georgetson, AGNP-C, Principal investigator, Robert Packer Hospital Sayre PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518369
- Sponsor's protocol ID
- 2401-02
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of a Preoperative Prehabilitation Program Among Rural Geriatric Patients Compared to Standard of Care
- ClinicalTrials.gov ID
- NCT06518369
- Acronym / sponsor ID
- 2401-02
- Conditions
- Surgery
- Keywords
- Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 24 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.
The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.
Detailed description
The study will include patients who require elective major abdominal surgery. The study will compare patients who received standard of care to patients who received a prehabilitation program before surgery.
The prehabilitation program will take place for 4-6 weeks before your surgery and will include:
- Review of frailty risk analysis calculator score obtained in the frailty study (#2212-74)
- Review of lab results including complete blood count, creatinine, albumin, and prealbumin
- Review of chronic conditions
- An office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.
- Drinking Surgery Immunonutrition shake twice daily for 5 days before surgery.
- Educational information and video instruction
- Weekly phone calls to motivate, ensure adherence, and assess progress.
- Measurements of hand grip strength and body weight
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intervention or standard of care group | – | –20 Patients who received standard of care |
| Prehabilitation Group | – | Other: Prehabilitation10 patients who take part in a prehabilitation program for 4-6 weeks before surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over age 60 who require elective major abdominal surgery
Key inclusion criteria (1 listed)
- Subjects over age 60 who require elective major abdominal surgery
Key exclusion criteria (1 listed)
- pregnant women
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 |
|---|---|---|
| PrehabilitationPrehabilitation program for 4-6 weeks before surgery will include: * Review of the frailty risk analysis calculator score obtained in the frailty study (#2212-74) * Review of lab results including complete blood count, creatinine, albumin, and prealbumin * Review of chronic conditions. * An office visit or telehealth visit to review instructions on instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease. * Drinking surgery immunonutrition drinks twice daily for 5 days before surgery. * Educational information and video instruction * Weekly phone calls to motivate, ensure adherence, and assess progress. * Measurements of hand grip strength and body weight | Other | Prehabilitation Group |
Primary outcome
Postoperative hospital length of stay
Time frame: From date of hospitalization until date of hospital discharge, up to 30 days
Number of days in hospital from date of surgery to date of discharge
Discharge disposition
Time frame: From date of hospitalization until date of hospital discharge, up to 30 days
Binary measure of either home or rehabilitation facility
2 secondary outcomes
Adverse outcomes after surgery
Time frame: 30 days after surgery
Hospital readmission rates
Time frame: 30 days 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 8 Jun 2025.
- 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.
Nancy Georgetson, AGNP-C principal investigator
Robert Packer Hospital Sayre PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by The Guthrie Clinic at 1 site in United States.
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 1 inclusion and 1 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 8 Jun 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 United States. 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 hospital length of stay (time frame: From date of hospitalization until date of hospital discharge, up to 30 days). 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?
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 8 Jun 2025.