FrailtyNCT06874413
Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
A study testing Prehabilitation in people with Frailty and Ventral Hernia, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The purpose of this study is to assess the physical fitness of patients undergoing hernia repair and correlate the postoperative outcomes and recovery as well as assess the impact of a targeted physical exercise program preoperatively in a cohort of frail, elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Ventral Hernia
- What is being tested?
- Prehabilitation
- 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 siteUnited States
- Study dates
- 19 Mar 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Groups 1 \& 2:
- Age 65 or greater
- Presence of a ventral hernia with plans for elective hernia repair with mesh
- Willing to consent to study and randomization, including activity data capture
- Score of ≥6 and ≤11 on the Edmonton Frail Scale OR 5-item modified Frail Index Score > 0
- For patients with cardiac disease, additional referral for cardiac risk assessment may be performed at the discretion of the treating surgeon or anesthesiologist. If deemed appropriate risk, patients may still enroll.
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- Uses a smartphone that is capable of downloading the Health Kit application
- Group 3:
- Age 18 or older
- Presence of a ventral hernia or inguinal hernia with plans for elective repair with mesh
- Willing to consent to activity data capture
- Uses a smartphone that is capable of downloading the Health Kit application
Who cannot join
- Group 1 \&2:
- Age <65
- Unwilling or unable to consent to study or randomization
- Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report
- Score of ≥12 on Edmonton Frail Scale
- mFI-5 positive for congestive heart failure (newly diagnosed or exacerbated within 30 days)
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- Functional dependence that prevents self-guided physical prehabilitation or other condition medically unsuitable for exercises (as determined by surgeon).
- BMI >50
- Parastomal hernia repair or repair without mesh
- Plan for concurrent procedure
- Group 3:
- <18 y/o
- Unwilling or unable to consent to study
- Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report
- BMI >50
- Parastomal hernia repair or repair without mesh
- Plan for concurrent procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to assess the physical fitness of patients undergoing hernia repair and correlate the postoperative outcomes and recovery as well as assess the impact of a targeted physical exercise program preoperatively in a cohort of frail, elderly patients.
The investigators hypothesize that physical exercise will improve activity levels in elderly patients with frailty prior to ventral hernia repair. The investigators further hypothesize that increased levels of activity preoperatively will correlate with improved postoperative outcomes.
Read the detailed description
The goals of this study are to:
- assess the impact of a targeted physical exercise program on activity levels prior to ventral hernia repair in elderly, frail patients using wearable activity monitoring.
- correlate physical activity and the impact of physical exercise with postoperative outcomes, including quality of life, postoperative complications, length of hospital stay, discharge to home, and return to baseline activity.
The investigators intend to randomize one group of elderly, frail patients to perform an exercise program for 6-8 weeks prior to surgery and another group of elderly, frail patients to receive standard of care preoperative instructions.
The investigators will also collect data from a cohort of patients receiving a ventral or inguinal hernia repair who have a wearable activity monitor that are willing to download an application on their phone and allow us to monitor their activity levels prior to surgery.
- Conditions
- Frailty, Ventral Hernia
- Being tested
- Prehabilitation, Standard of Care (SOC)
- Medical subject headings
- Frailty, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
Physical prehabilitation or exercise conducted through the YMCA's Silver Sneaker's program prior to receiving surgery that will be assessed through the use of wearable activity monitors.
Standard of Care (SOC)Other
Patients will receive standard of care preoperative instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Standard of Care | Active comparator | Patient receives standard of care instructions for preparing for ventral hernia repair surgery and recovery. Postoperative outcomes are measured. Receives: Other: Standard of Care (SOC) |
| Group 2 - Physical Exercise Arm | Experimental | Elderly patients with frailty participate in a 6-8 weeks of physical exercise program through the YMCA's SilverSneakers Program monitored by a wearable activity monitor. Patients will also complete respiratory training by using an incentive spirometer daily. Postoperative outcomes are measured Receives: Behavioral: Prehabilitation |
| Group 3 - Observational Cohort | No intervention | Patient's physical activity is monitored prior to receiving ventral or inguinal hernia repair surgery and postoperative outcomes are measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity levels
Amount of time spent active measured by data from wearable activity monitors
Measured: 6-8 weeks preoperatively
Secondary outcomes (7)
Quality of Life Pre- and Postoperative Assessment
Quality of life will be measured with the Hernia-Related Quality of Life Survey (HerQLes). This survey is a 12 question survey that measures how strongly the patient agrees or disagrees (strongly, moderately, and slightly agree or disagree) with the statement.
Measured: 14-30 days postoperatively
Quality of Life Pre- and Postoperative Outcomes
Quality of life as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-3).
Measured: 14-30 days postoperatively
Quality of Life Pre- and Postoperative Outcomes
Quality of life as measured by the Patient-Reported Outcome Measurement Information System (EuraHS).
Measured: 14-30 days postoperatively
Postoperative Outcomes - Surgical Complications
Postoperative complications
Measured: 14-30 days postoperatively
Postoperative Outcomes - Length of Stay
Number of days staying in the hospital prior to discharge
Measured: 14-30 days postoperatively
Postoperative Outcomes - Discharge Location
Discharge location
Measured: 14-30 days postoperatively
Postoperative Outcomes - Return to Baseline
Ability to return to baseline activity
Measured: 14-30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start19 Mar 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Warren, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874413
- Sponsor's protocol ID
- 2290314
- Status last verified
- May 2026
- First submitted
- 18 Feb 2025
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT06874413
- Acronym / sponsor ID
- 2290314
- Conditions
- Frailty, Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Mar 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.
The purpose of this study is to assess the physical fitness of patients undergoing hernia repair and correlate the postoperative outcomes and recovery as well as assess the impact of a targeted physical exercise program preoperatively in a cohort of frail, elderly patients.
The investigators hypothesize that physical exercise will improve activity levels in elderly patients with frailty prior to ventral hernia repair. The investigators further hypothesize that increased levels of activity preoperatively will correlate with improved postoperative outcomes.
Detailed description
The goals of this study are to:
- assess the impact of a targeted physical exercise program on activity levels prior to ventral hernia repair in elderly, frail patients using wearable activity monitoring.
- correlate physical activity and the impact of physical exercise with postoperative outcomes, including quality of life, postoperative complications, length of hospital stay, discharge to home, and return to baseline activity.
The investigators intend to randomize one group of elderly, frail patients to perform an exercise program for 6-8 weeks prior to surgery and another group of elderly, frail patients to receive standard of care preoperative instructions.
The investigators will also collect data from a cohort of patients receiving a ventral or inguinal hernia repair who have a wearable activity monitor that are willing to download an application on their phone and allow us to monitor their activity levels prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Standard of Care | Active comparator | Other: Standard of Care (SOC)Patient receives standard of care instructions for preparing for ventral hernia repair surgery and recovery. Postoperative outcomes are measured. |
| Group 2 - Physical Exercise Arm | Experimental | Behavioral: PrehabilitationElderly patients with frailty participate in a 6-8 weeks of physical exercise program through the YMCA's SilverSneakers Program monitored by a wearable activity monitor. Patients will also complete respiratory training by using an incentive spirometer daily. Postoperative outcomes are measured |
| Group 3 - Observational Cohort | No intervention | –Patient's physical activity is monitored prior to receiving ventral or inguinal hernia repair surgery and postoperative outcomes are measured. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Groups 1 \& 2:
- Group 3:
Key exclusion criteria (17 listed)
- Group 1 \&2:
- <18 y/o
- Unwilling or unable to consent to study
- Joint or muscle pain with movement at a level of 5 out of 10 or higher per patient report
- BMI >50
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 |
|---|---|---|
| PrehabilitationPhysical prehabilitation or exercise conducted through the YMCA's Silver Sneaker's program prior to receiving surgery that will be assessed through the use of wearable activity monitors. | Behavioural | Group 2 - Physical Exercise Arm |
| Standard of Care (SOC)Patients will receive standard of care preoperative instructions. | Other | Group 1 - Standard of Care |
Primary outcome
Activity levels
Time frame: 6-8 weeks preoperatively
Amount of time spent active measured by data from wearable activity monitors
7 secondary outcomes
Quality of Life Pre- and Postoperative Assessment
Time frame: 14-30 days postoperatively
Quality of Life Pre- and Postoperative Outcomes
Time frame: 14-30 days postoperatively
Quality of Life Pre- and Postoperative Outcomes
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Surgical Complications
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Length of Stay
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Discharge Location
Time frame: 14-30 days postoperatively
Postoperative Outcomes - Return to Baseline
Time frame: 14-30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- 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.
Jeremy Warren, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Frailty and Ventral Hernia, run by Prisma Health-Upstate 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 12 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 27 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Activity levels (time frame: 6-8 weeks preoperatively). 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 27 May 2026.