FrailtyPREVENTNCT04485611
Prehabilitation of Veterans With Exercise and Nutrition
A study testing Supervised aerobic + resistance training and nutritional support in people with Frailty, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of VA's RR\&D office is to maximize functional recovery. This proposal will allow the investigators to test an intervention that combines the fundamentals of Physical Medicine and Rehabilitation with state-of-the-art nutritional support and innovations in care such as telehealth and the use of activity… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Supervised aerobic + resistance training and nutritional support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for high-risk surgery
- Time from assessment to surgery 21 days
- Age 50 years
- English speaking
- 5RSTS time >11 sec and/or TMST score 25% percentile for gender/age
Who cannot join
- A score of <21 (high school) or <20 (less than high school) on the Montreal Cognitive Assessment (MoCA)
- Dementia diagnosis
- Inability to complete physical function assessment
- ASA categories 4 and 5
- Living in skilled nursing facility
- No access to a telephone
- Advanced chronic kidney disease (KDIGO stage 4 and 5)
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)
The goal of VA's RR\&D office is to maximize functional recovery. This proposal will allow the investigators to test an intervention that combines the fundamentals of Physical Medicine and Rehabilitation with state-of-the-art nutritional support and innovations in care such as telehealth and the use of activity trackers to optimize patients before high-risk surgery. This intervention has the potential to not only reduce complications and hospital readmissions, but also to maximize functional recovery and quality of life for thousands of Veterans undergoing high-risk surgery every year. Furthermore, the proposal is the first step in the design and implementation of prehabilitative services for Veterans living in rural areas and those with inadequate support or transportation.
Read the detailed description
Approximately half a million operations are performed each year in VA hospitals across the country. Veterans undergoing high-risk surgery have a 1 in 5 chance of suffering complications, a 1 in 10 chance of being readmitted to the hospital within 30 days, and a 1 in 50 chance of dying within 30 days. Long-term survival is significantly reduced for those patients who have perioperative complications, even if they survive to leave the hospital.
Low fitness and poor functional status are among the strongest predictors of postsurgical complications. Prehabilitation takes advantage of the weeks leading up to surgery in order to improve fitness, mobility and nutrition in preparation for the upcoming surgical stress. Indeed, prehabilitation has been shown to improve fitness and reduce complications and quality of life in high-risk surgical patients. The most effective prehabilitation programs combine exercise plus nutritional support (are multimodal), and provide exercise that is supervised and individualized, ensuring the appropriate exercise intensity and increasing it gradually according to improvements in fitness and strength. Most supervised prehabilitation programs are facility-based, but travel time, distance, and transportation limit participation. Unfortunately, home-based prehabilitation programs have shown small effect sizes and low compliance rates, likely because adequate training intensity is required in programs of such short duration, which is often not achieved with unsupervised home-based programs. A prehabilitation program that is delivered using telehealth would be ideal, because it combines accessibility with supervision, encouraging compliance and ensuring adequate training intensity, but such programs do not currently exit within the VA.
The investigators aim to determine the feasibility, acceptability, safety, and effect size estimates for outcomes of interest of a short-term (3-4 week) multimodal prehabilitation intervention that is supervised and individualized, yet is delivered at home using telehealth technology. The exercise program will consist of 3 days of supervised telehealth exercise sessions per week consisting of moderate intensity aerobic training and resistive and functional training. Nutritional support will consist of tailored nutritional advice, whey protein supplementation and multivitamin and vitamin D supplementation during prehabilitation and following hospital discharge for 6 weeks. Compliance with the interventions will be enhanced by daily automated text messages using the VA Annie App. In addition, participants will be contacted weekly in order to identify problems with compliance and to provide counseling. Post-operative exercise sessions will resume as early as 1 week postoperatively and progressed as allowed according to the type of surgery. Text messages and weekly calls will also resume postoperatively until the 6-week follow-up visit to encourage progressive increases in unsupervised physical activity and nutritional support. Objective physical activity data will be collected using physical activity trackers, which patients will wear from the time of enrollment until the 6-week postoperative follow-up visit. Follow-up will continue for a total of 6 months postoperatively.
The main outcomes of interest include feasibility (acceptance rates), acceptability (compliance rates), and safety (number of adverse events). The investigators will also measure changes in fitness, nutritional state, anxiety and depression, and health-related quality of life throughout the study period in order to estimate effect sizes, which will inform a future randomized trial. The proposed work combines several innovations in the delivery of exercise and nutrition and applies them to the perioperative high-risk population for the first time. It constitutes the first step toward the study of a multimodal "tele-prehabilitation" program on postoperative and long-term outcomes following high-risk surgery.
- Conditions
- Frailty
- Being tested
- Supervised aerobic + resistance training and nutritional support
- Keywords
- frailty, exercise training, telemedicine, nutritional support
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised aerobic + resistance training and nutritional supportBehavioural
Also called Multimodal prehabilitation
The intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements]]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group. Receives: Behavioral: Supervised aerobic + resistance training and nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Measured as Acceptance Rate
Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.
Measured: From initial screening to enrollment (~7 days)
Acceptability, Measured as Compliance Rate
For the exercise intervention, the investigators will measure the percentage of patients completing 75% of sessions divided by the number of enrolled patients. For the nutritional intervention, compliance will be measured by the percentage of patients with 75% adherence to protein intake goal, as assessed using the text message-based nutrition diary and 24-hour recall administered during the weekly telephone call.
Measured: End of prehabilitation (week 3) and end of rehabilitation (week 14)
Safety, Measured as the Number of Adverse Events During Exercise.
A significant injury or medical event is defined as an event that causes the participant to seek attention from a health professional or limits their activities of daily living for at least two days.
Measured: Throughout the study period, and summarized at the end of prehabilitation (week 3) and end of rehabilitation (week 14)
Secondary outcomes (5)
Physical Function - Aerobic Endurance
Aerobic endurance will be assessed using the 2-minute step test (2MST). The 2MST requires that tested individuals march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crest when standing (typically marked on the wall using tape). Scoring involves counting the number of times the right knee reaches the tape level in two minutes and comparing against normative values for age. A higher number denotes better aerobic endurance.
Measured: Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), and post-rehabilitation (week 14)
Physical Function - Lower Extremity Strength and Balance
Lower extremity strength and balance will be assessed using the 5-repetition sit-to-stand test (5XSST). The 5XSST assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test. The age matched norms score are 11.4 seconds for 60-69 years age groups and 12.6 seconds and 14.8 seconds for 70-79 and 80-89 years of age group ,respectively.
Measured: Baseline, end of prehabilitation (week 3), post-surgery (variable but typically ~week 8), and post-rehabilitation (week 14)
Hospital Anxiety & Depression Scale (HADS): Anxiety (HADS-A)
Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety \& Depression Scale (HADS) questionnaire. Lower scores are better.
0-7: Indicates no or minimal anxiety. 8-10: Suggests mild anxiety. 11-15: Indicates moderate anxiety. 16-21: Suggests severe anxiety.
Measured: Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), post-rehabilitation (week 14), and 4-month post-rehabilitation follow-up (week 32)
Hospital Anxiety & Depression Scale (HADS): Depression (HADS-D)
Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety \& Depression Scale (HADS) questionnaire. Lower scores are better.
0-7: Indicates no or minimal depression. 8-10: Suggests mild depression. 11-15: Indicates moderate depression. 16-21: Suggests severe depression.
Measured: Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), post-rehabilitation (week 14), and 4-month post-rehabilitation follow-up (week 32)
Short Form 36 (SF-36)
Pre to post intervention changes in quality of life as measured by the Short Form 36 (SF-36) questionnaire.
The SF-36 is a 36-item patient-reported questionnaire designed to assess health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health.
Measured: Baseline, post-rehabilitation (~week 14), and 4-month post-rehabilitation follow-up (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start27 May 2021
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention will consist of a period of supervised multimodal prehabilitation prior to high-risk surgery (aerobic and resistance training sessions 3 times/week plus nutritional support) delivered using telehealth technology, and similar sessions resuming after surgery and for up to 6 weeks (rehabilitation).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Atilio Barbeito, MD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485611
- Sponsor's protocol ID
- F3468-P
- Other IDs
- 728745
- Acronym
- PREVENT
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2020
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)
- ClinicalTrials.gov ID
- NCT04485611
- Acronym / sponsor ID
- PREVENT / F3468-P
- Conditions
- Frailty
- Keywords
- frailty, exercise training, telemedicine, nutritional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Duke University
- Study start
- 27 May 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of VA's RR\&D office is to maximize functional recovery. This proposal will allow the investigators to test an intervention that combines the fundamentals of Physical Medicine and Rehabilitation with state-of-the-art nutritional support and innovations in care such as telehealth and the use of activity trackers to optimize patients before high-risk surgery. This intervention has the potential to not only reduce complications and hospital readmissions, but also to maximize functional recovery and quality of life for thousands of Veterans undergoing high-risk surgery every year. Furthermore, the proposal is the first step in the design and implementation of prehabilitative services for Veterans living in rural areas and those with inadequate support or transportation.
Detailed description
Approximately half a million operations are performed each year in VA hospitals across the country. Veterans undergoing high-risk surgery have a 1 in 5 chance of suffering complications, a 1 in 10 chance of being readmitted to the hospital within 30 days, and a 1 in 50 chance of dying within 30 days. Long-term survival is significantly reduced for those patients who have perioperative complications, even if they survive to leave the hospital.
Low fitness and poor functional status are among the strongest predictors of postsurgical complications. Prehabilitation takes advantage of the weeks leading up to surgery in order to improve fitness, mobility and nutrition in preparation for the upcoming surgical stress. Indeed, prehabilitation has been shown to improve fitness and reduce complications and quality of life in high-risk surgical patients. The most effective prehabilitation programs combine exercise plus nutritional support (are multimodal), and provide exercise that is supervised and individualized, ensuring the appropriate exercise intensity and increasing it gradually according to improvements in fitness and strength. Most supervised prehabilitation programs are facility-based, but travel time, distance, and transportation limit participation. Unfortunately, home-based prehabilitation programs have shown small effect sizes and low compliance rates, likely because adequate training intensity is required in programs of such short duration, which is often not achieved with unsupervised home-based programs. A prehabilitation program that is delivered using telehealth would be ideal, because it combines accessibility with supervision, encouraging compliance and ensuring adequate training intensity, but such programs do not currently exit within the VA.
The investigators aim to determine the feasibility, acceptability, safety, and effect size estimates for outcomes of interest of a short-term (3-4 week) multimodal prehabilitation intervention that is supervised and individualized, yet is delivered at home using telehealth technology. The exercise program will consist of 3 days of supervised telehealth exercise sessions per week consisting of moderate intensity aerobic training and resistive and functional training. Nutritional support will consist of tailored nutritional advice, whey protein supplementation and multivitamin and vitamin D supplementation during prehabilitation and following hospital discharge for 6 weeks. Compliance with the interventions will be enhanced by daily automated text messages using the VA Annie App. In addition, participants will be contacted weekly in order to identify problems with compliance and to provide counseling. Post-operative exercise sessions will resume as early as 1 week postoperatively and progressed as allowed according to the type of surgery. Text messages and weekly calls will also resume postoperatively until the 6-week follow-up visit to encourage progressive increases in unsupervised physical activity and nutritional support. Objective physical activity data will be collected using physical activity trackers, which patients will wear from the time of enrollment until the 6-week postoperative follow-up visit. Follow-up will continue for a total of 6 months postoperatively.
The main outcomes of interest include feasibility (acceptance rates), acceptability (compliance rates), and safety (number of adverse events). The investigators will also measure changes in fitness, nutritional state, anxiety and depression, and health-related quality of life throughout the study period in order to estimate effect sizes, which will inform a future randomized trial. The proposed work combines several innovations in the delivery of exercise and nutrition and applies them to the perioperative high-risk population for the first time. It constitutes the first step toward the study of a multimodal "tele-prehabilitation" program on postoperative and long-term outcomes following high-risk surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention will consist of a period of supervised multimodal prehabilitation prior to high-risk surgery (aerobic and resistance training sessions 3 times/week plus nutritional support) delivered using telehealth technology, and similar sessions resuming after surgery and for up to 6 weeks (rehabilitation).
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Supervised aerobic + resistance training and nutritional supportThis pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for high-risk surgery
- Time from assessment to surgery 21 days
- Age 50 years
- English speaking
- 5RSTS time >11 sec and/or TMST score 25% percentile for gender/age
Key exclusion criteria (7 listed)
- A score of <21 (high school) or <20 (less than high school) on the Montreal Cognitive Assessment (MoCA)
- Dementia diagnosis
- Inability to complete physical function assessment
- ASA categories 4 and 5
- Living in skilled nursing facility
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 |
|---|---|---|
| Supervised aerobic + resistance training and nutritional supportAlso: Multimodal prehabilitationThe intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements]]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers. | Behavioural | Prehabilitation |
Primary outcome
Feasibility, Measured as Acceptance Rate
Time frame: From initial screening to enrollment (~7 days)
Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.
Acceptability, Measured as Compliance Rate
Time frame: End of prehabilitation (week 3) and end of rehabilitation (week 14)
For the exercise intervention, the investigators will measure the percentage of patients completing 75% of sessions divided by the number of enrolled patients. For the nutritional intervention, compliance will be measured by the percentage of patients with 75% adherence to protein intake goal, as assessed using the text message-based nutrition diary and 24-hour recall administered during the weekly telephone call.
Safety, Measured as the Number of Adverse Events During Exercise.
Time frame: Throughout the study period, and summarized at the end of prehabilitation (week 3) and end of rehabilitation (week 14)
A significant injury or medical event is defined as an event that causes the participant to seek attention from a health professional or limits their activities of daily living for at least two days.
5 secondary outcomes
Physical Function - Aerobic Endurance
Time frame: Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), and post-rehabilitation (week 14)
Physical Function - Lower Extremity Strength and Balance
Time frame: Baseline, end of prehabilitation (week 3), post-surgery (variable but typically ~week 8), and post-rehabilitation (week 14)
Hospital Anxiety & Depression Scale (HADS): Anxiety (HADS-A)
Time frame: Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), post-rehabilitation (week 14), and 4-month post-rehabilitation follow-up (week 32)
Hospital Anxiety & Depression Scale (HADS): Depression (HADS-D)
Time frame: Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), post-rehabilitation (week 14), and 4-month post-rehabilitation follow-up (week 32)
Short Form 36 (SF-36)
Time frame: Baseline, post-rehabilitation (~week 14), and 4-month post-rehabilitation follow-up (week 32)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Atilio Barbeito, MD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised aerobic + resistance training and nutritional support in people with Frailty, run by VA Office of Research and Development 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 5 inclusion and 7 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 Aug 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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility, Measured as Acceptance Rate (time frame: From initial screening to enrollment (~7 days)). The study lists 3 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 Aug 2025.