Multi-Component Prehabilitation for Major Elective Surgery

NCT05752474 | Completed Results

• 1 other identifier: 2022P000090
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to assess the feasibility of delivering a multicomponent prehabilitation and measuring patient-centered outcomes in older adults undergoing major surgery.

Conditions

Frailty; Functional Recovery; Prehabilitation

Keywords

Prehabilitation; Surgery; Feasibility Studies

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Prehabilitation Program

  Measurement: Percentage of patients to whom we can deliver an adequate dose (≥50% of the planned sessions) of the 3 core interventions: physical therapy (≥4/8 sessions), nutrition (≥2/3-4 sessions), and meditation (≥2/3-4 sessions). Range: 0-100% (higher values indicate higher feasibility).

  Post-intervention (up to 4 weeks)

Secondary Outcomes (6)

• Change in 5-chair Stand Test Time

  Between pre-intervention baseline and post-intervention (up to 4 weeks)

• Change in Dominant Handgrip Strength

  Between pre-intervention baseline and post-intervention (up to 4 weeks)

• Adherence to Exercise

  Post-intervention (up to 4 weeks)

• Adherence to Nutrition

  Post-intervention (up to 4 weeks)

• Adherence to Meditation

  Post-intervention (up to 4 weeks)

Other Outcomes (14)

• Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Physical Function T Score

  Between pre-intervention baseline and 90 days after surgery

• Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Anxiety T Score

  Between pre-intervention baseline and 90 days after surgery

• Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Depression T Score

  Between pre-intervention baseline and 90 days after surgery

Study Arms (1)

Prehabilitation

EXPERIMENTAL

This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.

Behavioral: Exercise; Behavioral: Nutrition; Behavioral: Meditation; Behavioral: Cognitive Behavioral Intervention

Interventions

Exercise BEHAVIORAL

Physical therapy targeting flexibility, strength, and endurance will be delivered at the participant's home, center-based, or virtually via a twice-weekly (on average) schedule to provide a total of about 6-8 sessions during the 3-4 week study period. Participants will be asked to participate in self-directed exercise for at least 30 minutes per day for 4 or more days per week.

Prehabilitation

Nutrition BEHAVIORAL

One-hour virtual group nutrition education classes will be held once per week by a dietitian, focusing on optimal protein intake (1.2 grams per kg of body weight) for lean body mass preservation (from food sources and oral nutritional supplements) and muscle gain. Participants will also receive oral nutritional supplements (20-30 grams of protein/day provided by our study team).

Prehabilitation

Meditation BEHAVIORAL

One-hour virtual group meditation sessions will be held once per week by an experienced meditation teacher. Classes will focus on breathing techniques, yoga, and mindful meditation practices. Participants will be asked to participate in self-directed meditation for at least 12 minutes daily.

Prehabilitation

Cognitive Behavioral Intervention BEHAVIORAL

A 30-min telephone-based session with individual patients will take place to deliver cognitive behavioral strategies once per week by a professionally trained clinician. These strategies include education about frailty and surgery, increasing positive beliefs of the benefits of exercise and nutrition, discussing barriers, setting individualized goals for surgery and recovery, developing a detailed exercise and nutrition plan (including logistics), self-monitoring of progress using weekly exercise, diet, and meditation logs, and enhancing self-efficacy through the celebration of small wins.

Prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient is scheduled to have a gastrointestinal, gynecological oncologic, urologic, and cardiovascular procedure
• Age 70 years+
• Age 65 years+ AND high risk per surgeon's clinical judgment
• Patient provides an informed e-consent or remote consent

You may not qualify if:

• Surgery is scheduled less than 21 days
• Patient is considered an inappropriate candidate per the surgeon's assessment
• Non-English speaking
• Major cognitive impairment
• Patients with chronic kidney disease stage 3 or higher will be excluded from receiving protein supplement of the prehabilitation program

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Hebrew SeniorLife: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Wang KY, Xu K, Liu Y, Alshanniek S, Newmeyer N, Mesnik L, Prudhivi V, Chase T, Rangasamy V, Sison SM, Shi SM, Travison TG, Subramaniam B, Kim DH. Multi-Component Prehabilitation Program for Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study. J Am Geriatr Soc. 2025 Nov;73(11):3387-3395. doi: 10.1111/jgs.70095. Epub 2025 Sep 7.

  PMID: 40916355 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Exercise; Nutritional Status; Meditation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The absence of a control group without prehabilitation does not allow evaluation of the intervention effect. The prehabilitation program was delivered by a clinical team with extensive experience in geriatric care. The feasibility in our study may not generalize to patients treated at other hospitals.

Results Point of Contact

• Title: Dae Hyun Kim
• Organization: Hebrew Rehabilitation Center, Hebrew SeniorLife

daehyunkim@hsl.harvard.edu

6179715362

Study Officials

• Dae Hyun Kim, MD, ScD

  Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 2, 2023
• Study Start: March 27, 2023
• Primary Completion: January 16, 2025
• Study Completion: January 16, 2025
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)