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| ID | Type | Description | Link |
|---|---|---|---|
| 728745 | Other Grant/Funding Number | VA RR&D |
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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised aerobic + resistance training and nutritional support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, Measured as Acceptance Rate | Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients. | 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. | 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. | Throughout the study period, and summarized at the end of prehabilitation (week 3) and end of rehabilitation (week 14) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atilio Barbeito, MD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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20 patients were enrolled in the study. One patient underwent the baseline evaluation but withdrew before starting the intervention.
One patient enrolled but his clinical condition changed and was therefore withdrawn from the study before the initial baseline evaluation was completed.
A total of 18 participants started the prehabilitation intervention.
Recruitment began 05/27/2021 Recruitment ended 10/18/2023
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group. Supervised aerobic + resistance training and nutritional support: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prehabilitation |
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| Rehabilitation |
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A total of 63 patients were screened and offered to participate, and 29 agreed to enroll and undergo a physical function evaluation. Of these, 20 patients (69%) were frail or pre-frail and qualified for the intervention. One patient withdrew before the initial evaluation was completed. One patient completed the baseline evaluation but was later withdrawn from the study due to a change in his medical condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prehabilitation | This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group. Supervised aerobic + resistance training and nutritional support: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility, Measured as Acceptance Rate | Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients. | Posted | Count of Participants | Participants | From initial screening to enrollment (~7 days) |
|
Adverse events were captured throughout the study period and summarized at the end of prehabilitation (week 3) and end of rehabilitation (week 14)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline | This cohort underwent supervised aerobic + resistance training and nutritional support. The intervention consisted of individualized exercise training delivered remotely using VA telehealth technology 3 times per week during the 3 weeks leading up to surgery, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements. Adherence to the intervention was enhanced by use of automated text messages. The study did not include a comparator group. |
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The data used to calculate the effect of the interventions was derived from in-person assessments when available. Due to the nature of the study, some assessments could not be completed in person and were completed using telehealth technology.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Atilio Barbeito, Chief, Anesthesiology Service | Durham VA Health Care System | (919) 286-6938 | 177150 | atilio.barbeito@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2021 | Feb 26, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2021 | May 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D018529 | Nutritional Support |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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).
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|
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| 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. | 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. | 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. | 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. | Baseline, post-rehabilitation (~week 14), and 4-month post-rehabilitation follow-up (week 32) |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kg/m^2 |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | 20 patients were enrolled in the study. Two patients withdrew before starting the intervention and one patient began the prehabilitation phase but had to be withdrawn due to progression of disease. Two patients withdrew after recovering from surgery and before starting the rehabilitation phase. The last patient in the cohort was not offered rehabilitation (funding ended). A total of 14 patients began the rehabilitation phase of the intervention. | Posted | Count of Participants | Participants | End of prehabilitation (week 3) and end of rehabilitation (week 14) |
|
|
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| Primary | 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. | Posted | Number | participants | Throughout the study period, and summarized at the end of prehabilitation (week 3) and end of rehabilitation (week 14) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Step Count | Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), and post-rehabilitation (week 14) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Baseline, end of prehabilitation (week 3), post-surgery (variable but typically ~week 8), and post-rehabilitation (week 14) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-rehabilitation (~week 14), and 4-month post-rehabilitation follow-up (week 32) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Post-prehabilitation | This cohort underwent supervised aerobic + resistance training and nutritional support. The intervention consisted of individualized exercise training delivered remotely using VA telehealth technology 3 times per week during the 3 weeks leading up to surgery, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements. Adherence to the intervention was enhanced by use of automated text messages. The study did not include a comparator group. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Post-surgery | This cohort underwent supervised aerobic + resistance training and nutritional support. The intervention consisted of individualized exercise training delivered remotely using VA telehealth technology 3 times per week during the 6 weeks following recovery from surgery, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements. Adherence to the intervention was enhanced by use of automated text messages. The study did not include a comparator group. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Post-rehabilitation | This cohort underwent supervised aerobic + resistance training and nutritional support. The intervention consisted of individualized exercise training delivered remotely using VA telehealth technology 3 times per week during the 6 weeks following recovery from surgery, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements. Adherence to the intervention was enhanced by use of automated text messages. The study did not include a comparator group. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D044623 | Nutrition Therapy |
|
| Prehabilitation - Nutrition |
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| Rehabilitation - Nutrition |
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