Prehabilitation of Veterans With Exercise and Nutrition

NCT04485611 | Completed Results

• 2 other identifiers: F3468-P728745
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Frailty

Keywords

frailty; exercise training; telemedicine; nutritional support

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (5)

• Physical Function - Aerobic Endurance

  Baseline, end of prehabilitation (week 3), post-surgery (variable but ~week 8), and post-rehabilitation (week 14)

• Physical Function - Lower Extremity Strength and Balance

  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)

  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)

  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)

  Baseline, post-rehabilitation (~week 14), and 4-month post-rehabilitation follow-up (week 32)

Study Arms (1)

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.

Behavioral: Supervised aerobic + resistance training and nutritional support

Interventions

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.

Also known as: Multimodal prehabilitation

Prehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for high-risk surgery
• Time from assessment to surgery 21 days
• Age 50 years
• English speaking
• RSTS time \>11 sec and/or TMST score 25% percentile for gender/age

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Duke University: collaborator

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Resistance Training; Nutritional Support

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Atilio Barbeito, Chief, Anesthesiology Service
• Organization: Durham VA Health Care System

atilio.barbeito@va.gov

(919) 286-6938

Study Officials

• Atilio Barbeito, MD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 24, 2020
• Study Start: May 27, 2021
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)