Prehabilitation for Frailty

No longer recruiting at 1 trial location

Overseen By Dae Hyun Kim, MD, ScD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Non-English, Cognitive impairment, Chronic kidney, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination of exercise, nutrition, meditation, and cognitive behavioral therapy (a type of talk therapy) can help older adults prepare for major surgery. Researchers are evaluating whether this approach eases surgery and improves recovery. It targets individuals aged 70 and up, or those 65 and older deemed high-risk by their doctor, who are scheduled for specific major surgeries like gastrointestinal or heart procedures. Participants will begin the program 3-4 weeks before their surgery.

As an unphased trial, this study offers a unique opportunity to potentially enhance the surgical experience and recovery through a holistic approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation protocol is safe for older adults undergoing major surgery?

Previous studies have shown that cognitive behavioral interventions (a type of therapy involving talking and thinking) are well-tolerated by older adults. These interventions help reduce fear and anxiety without causing significant side effects. Research indicates that exercise is a key strategy for managing frailty (weakness or risk of falling) in older adults. Exercise programs have proven safe and effective for improving physical health.

Meditation, especially mindfulness practices, has demonstrated positive effects on mental well-being. These practices are generally safe with few reported side effects. Nutrition interventions, which focus on improving diet, are also considered safe and are recommended to help prevent frailty in older adults.

Overall, research supports the components of this prehabilitation program—cognitive behavioral therapy, exercise, meditation, and nutrition—as safe and beneficial for older adults. They aim to improve health without posing major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this prehabilitation approach for frailty because it combines multiple interventions—exercise, nutrition, meditation, and cognitive behavioral techniques—into a comprehensive plan before surgery. Unlike standard treatments that often focus on recovery after surgery, this proactive method aims to strengthen patients beforehand, potentially reducing complications and improving outcomes. This holistic approach targets not just the physical but also the mental aspects of frailty, offering a more balanced path to better health.

What evidence suggests that this trial's treatments could be effective for frailty?

Research shows that exercise is important for improving frailty in older adults. Studies indicate that exercise strengthens muscles and lowers the risk of falls. Eating well, especially by adding protein to the diet, can also help reduce frailty when combined with exercise. Meditation, such as mindfulness practices, improves mood and reduces anxiety, which is important for well-being in frail individuals. Cognitive behavioral methods have shown mixed results, but when paired with therapeutic exercises, they may lead to better personal outcomes. In this trial, participants will receive a multicomponent prehabilitation intervention that includes exercise, nutritional intervention, meditation, and cognitive behavioral intervention. Overall, this combined approach could help older adults prepare for surgery by boosting both physical and mental health. ^{6 7 8 9 10}

Who Is on the Research Team?

Dae Hyun Kim, MD, ScD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for older adults who are frail (with a frailty index of 0.25 or higher) and scheduled for major gastrointestinal, gynecological oncologic, or urologic surgery. Participants must be able to give informed electronic or remote consent.

Inclusion Criteria

My frailty index is 0.25 or higher.

Patient provides an informed e-consent or remote consent

I am scheduled for surgery related to my digestive, reproductive, or urinary system cancer.

Exclusion Criteria

Patient is considered an inappropriate candidate per the surgeon's assessment

My surgery is planned within the next 3 weeks.

I have significant memory or thinking problems confirmed by a test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a multicomponent prehabilitation program including exercise, nutritional intervention, meditation, and cognitive behavioral intervention

3-4 weeks

Surgery

Participants undergo major elective abdominal, gynecological oncologic, urologic, or cardiovascular surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery, with patient-centered outcomes measured at 30 and 90 days

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Intervention
• Exercise
• Meditation
• Nutrition

Trial Overview The study tests whether a combination of cognitive behavioral therapy, exercise routines, meditation practices, and nutritional planning can improve outcomes for patients before they undergo major elective surgeries.

How Is the Trial Designed?

Group I: Prehabilitation Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6665875/

A Person-Centered Prehabilitation Program Based on ... The objective was to investigate whether a person-centered physical therapy prehabilitation program, based on a cognitive-behavioral approach, is more effective ...

2. jospt.org jospt.org/doi/10.2519/jospt.2021.9748

A Systematic Review With Meta-analysis Results. Cognitive behavioral therapy interventions were no more effective than usual care for all outcomes. Pooled effect sizes were −2.0 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33356804/

A Systematic Review With Meta-analysis Results: Cognitive behavioral therapy interventions were no more effective than usual care for all outcomes. Pooled effect sizes were -2.0 (95% CI: -4.4 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000229

A Systematic Review of the Effects of Therapeutic Exercise ... Therapeutic exercise with psychological interventions have a positive effect on disability and personal outcomes, especially in participation.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2022/4276175

Evaluation of Cognitive Behavioral Therapy on Improving ... We found low-quality evidence that CBT was significantly more effective than other interventions (SMD 0.27, 95% CI 0.15 to 0.40, I2 = 74%, P = ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078567/

Cognitive behavioural interventions for reducing fear of falling ... Cognitive behavioural therapy (CBT) interventions have been developed for treating FoF. CBT is commonly referred to as a 'talking therapy', in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224001790

Adapting Cognitive Behavioral Therapy for the Frail Elderly This article briefly reviews the literature on the use of cognitive behavioral therapy (CBT) with the elderly, and suggests some changes in using CBT with the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11629493/

Tailored internet-delivered cognitive behavior therapy for ... The aim of this study was to examine the effects of tailored ICBT for depression in older adults aged 65 years or older.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/74/NCT05752474/Prot_000.pdf

Multi-Component Prehabilitation Program for High-Risk ... The purpose of this feasibility pilot study is to understand how a prehabilitation program for older adults with frailty can best be ...

10. academic.oup.com academic.oup.com/ptj/article/104/8/pzae069/7675430

Long-Term Follow-Up of a Person-Centered Prehabilitation ... No significant long-term effects were found for this cognitive behavioral prehabilitation program in comparison with conventional care for patients undergoing ...