FrailtyNCT05752474
Multi-Component Prehabilitation for Major Elective Surgery
A study testing Exercise, Nutrition and Meditation in people with Frailty and Functional Recovery, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Functional Recovery, Prehabilitation
- What is being tested?
- Exercise, Nutrition and Meditation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 16 Jan 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
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.
Read the detailed description
We will assess the feasibility of delivering a multicomponent prehabilitation, which consists of exercise (supervised by physical therapist), nutritional intervention (nutritional supplement and group education), meditation (group class), and cognitive behavioral intervention over 3-4 weeks before major elective abdominal, gynecological oncologic, urologic surgery, and cardiovascular procedures. We will also measure patient-centered outcomes (Patient-Reported Outcomes Measurement Information System) at 30 and 90 days after surgery. The target enrollment is 30 patients.
- Conditions
- Frailty, Functional Recovery, Prehabilitation
- Being tested
- Exercise, Nutrition, Meditation, Cognitive Behavioral Intervention
- Keywords
- Prehabilitation, Surgery, Feasibility Studies
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
NutritionBehavioural
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).
MeditationBehavioural
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.
Cognitive Behavioral InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise; Behavioral: Nutrition; Behavioral: Meditation; Behavioral: Cognitive Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-intervention (up to 4 weeks)
Secondary outcomes (6)
Change in 5-chair Stand Test Time
Measurement: Time to complete 5 chair stands (seconds), post-prehabilitation (up to 4 weeks) minus pre-prehabilitation baseline Range: 0 to 60 seconds Interpretation: Higher values indicate worse lower extremity strength.
Measured: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Change in Dominant Handgrip Strength
Measurement: Average of 3 measurements of dominant handgrip strength (kilograms) measured using a Jamar dynamometer, post-prehabilitation (up to 4 weeks) minus pre-prehabilitation baseline Range: 0 to 60 kilograms Interpretation: Higher values indicate greater muscle strength
Measured: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Adherence to Exercise
Measurement: percentage of physical therapy sessions attended Range: 0-100% (higher values indicate better adherence)
Measured: Post-intervention (up to 4 weeks)
Adherence to Nutrition
Measurement: percentage of nutrition sessions attended Range: 0-100% (higher values indicate better adherence)
Measured: Post-intervention (up to 4 weeks)
Adherence to Meditation
Measurement: percentage of meditation sessions attended Range: 0-100% (higher values indicate better adherence)
Measured: Post-intervention (up to 4 weeks)
Adverse Events
Measurement: percentage of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)
Measured: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start27 Mar 2023
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew SeniorLife
- Responsible party
- Principal investigator, Dae Hyun Kim, Beth Israel Deaconess Medical Center
- Investigators
- Dae Hyun Kim, MD, ScD, Principal investigator, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752474
- Sponsor's protocol ID
- 2022P000090
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2023
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this is a feasibility study of a multicomponent prehabilitation intervention, we do not plan to share individual participant data to other researchers.
Publications
Wang KY, Nguyen CY, Xu K, Liu Y, Newmeyer N, Alshanniek S, Palmer JA, Kim DH. Barriers and facilitators to prehabilitation participation among older adults undergoing major elective surgery: a qualitative study using the capability, opportunity, motivation - behavior model. BMC Geriatr. 2026 Feb 11;26(1):577. doi: 10.1186/s12877-026-07101-w.
PubMed 41668027Wang 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.
PubMed 40916355
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT05752474
- Acronym / sponsor ID
- 2022P000090
- Conditions
- Frailty, Functional Recovery, Prehabilitation
- Keywords
- Prehabilitation, Surgery, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Hebrew SeniorLife
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Posted 3 Dec 2025
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 pilot study is to assess the feasibility of delivering a multicomponent prehabilitation and measuring patient-centered outcomes in older adults undergoing major surgery.
Detailed description
We will assess the feasibility of delivering a multicomponent prehabilitation, which consists of exercise (supervised by physical therapist), nutritional intervention (nutritional supplement and group education), meditation (group class), and cognitive behavioral intervention over 3-4 weeks before major elective abdominal, gynecological oncologic, urologic surgery, and cardiovascular procedures. We will also measure patient-centered outcomes (Patient-Reported Outcomes Measurement Information System) at 30 and 90 days after surgery. The target enrollment is 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Exercise, Behavioral: Nutrition, Behavioral: Meditation, Behavioral: Cognitive Behavioral InterventionThis group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ExercisePhysical 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. | Behavioural | Prehabilitation |
| NutritionOne-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). | Behavioural | Prehabilitation |
| MeditationOne-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. | Behavioural | Prehabilitation |
| Cognitive Behavioral InterventionA 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. | Behavioural | Prehabilitation |
Primary outcome
Feasibility of the Prehabilitation Program
Time frame: Post-intervention (up to 4 weeks)
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).
6 secondary outcomes
Change in 5-chair Stand Test Time
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Change in Dominant Handgrip Strength
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Adherence to Exercise
Time frame: Post-intervention (up to 4 weeks)
Adherence to Nutrition
Time frame: Post-intervention (up to 4 weeks)
Adherence to Meditation
Time frame: Post-intervention (up to 4 weeks)
Adverse Events
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41668027Wang KY, Nguyen CY, Xu K, Liu Y, Newmeyer N, Alshanniek S, Palmer JA, Kim DH. Barriers and facilitators to prehabilitation participation among older adults undergoing major elective surgery: a qualitative study using the capability, opportunity, motivation - behavior model. BMC Geriatr. 2026 Feb 11;26(1):577. doi: 10.1186/s12877-026-07101-w.
- Derived from this study: PubMed 40916355Wang 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.
- Individual participant dataSharing planned: No. Because this is a feasibility study of a multicomponent prehabilitation intervention, we do not plan to share individual participant data to other researchers.
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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.
Dae Hyun Kim, MD, ScD principal investigator
Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Nutrition and Meditation in people with Frailty and Functional Recovery, run by Beth Israel Deaconess Medical Center 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 4 inclusion and 5 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 3 Dec 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 3 Dec 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 of the Prehabilitation Program (time frame: Post-intervention (up to 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752474, which also lists 2 linked publications.
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 3 Dec 2025.