Frailty, Functional Recovery, Prehabilitation
Conditions
Keywords
Prehabilitation, Surgery, Feasibility Studies
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.
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.
Interventions
BEHAVIORALExercise
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.
BEHAVIORALNutrition
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).
BEHAVIORALMeditation
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.
BEHAVIORALCognitive Behavioral Intervention
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.
Sponsors
Hebrew SeniorLife
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Prehabilitation Program | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dominant Handgrip Strength | Between pre-intervention baseline and post-intervention (up to 4 weeks) | 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 |
| Adherence to Exercise | Post-intervention (up to 4 weeks) | Measurement: percentage of physical therapy sessions attended Range: 0-100% (higher values indicate better adherence) |
| Change in 5-chair Stand Test Time | Between pre-intervention baseline and post-intervention (up to 4 weeks) | 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. |
| Adherence to Meditation | Post-intervention (up to 4 weeks) | Measurement: percentage of meditation sessions attended Range: 0-100% (higher values indicate better adherence) |
| Adverse Events | Between pre-intervention baseline and post-intervention (up to 4 weeks) | Measurement: percentage of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events) |
| Adherence to Nutrition | Post-intervention (up to 4 weeks) | Measurement: percentage of nutrition sessions attended Range: 0-100% (higher values indicate better adherence) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Intensity Score | Between pre-intervention baseline and 90 days after surgery | Measurement: Self-reported measure of pain intensity, 90 days after surgery minus pre-intervention baseline Range: 0 to 10 Interpretation: Higher scores indicate greater pain intensity |
| 3-D Confusion Assessment Method | Between postoperative day 1 and day 3 | Measurement: percentage of patients who develop delirium according to 3-D Confusion Assessment Method within 3 days of surgery |
| Comprehensive Complication Index | 1 month after surgery | Measurement: a composite complication grading system by Clavien-Dindo Classification (CDC) after an intervention Range: 0 (no complications) to 100 (death) Interpretation: Higher scores indicate more severe complications |
| 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 | Measurement: Self-reported measure of physical function, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate better physical function |
| 30-day Readmission From All Causes | Between surgery and 1 month after surgery | Measurement: percentage of patients who were readmitted within 30 days of surgery |
| 30-day Mortality From All Causes | 1 month | Measurement: proportion of patients who died within 30 days of surgery |
| 90-day Mortality From All Causes | Between surgery and 90 days after surgery | Measurement: percentage of patients who died within 90 days of surgery |
| Length of Stay | Between surgery and 1 month after surgery | Measurement: Number of hospital days from surgery until discharge |
| 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 | Measurement: Self-reported measure of anxiety, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater anxiety |
| 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 | Measurement: Self-reported measure of depression, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate more depressive mood |
| Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Fatigue T Score | Between pre-intervention baseline and 90 days after surgery | Measurement: Self-reported measure of fatigue, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate worse fatigue |
| Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Sleep Disturbance T Score | Between pre-intervention baseline and 90 days after surgery | Measurement: Self-reported measure of sleep disturbance, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater sleep disturbance |
| Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Social Roles/Activities Participation T Score | Between pre-intervention baseline and 90 days after surgery | Measurement: Self-reported measure of participation in social roles/activities, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater participation in social roles/activities |
| Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Interference T Score | Between pre-intervention baseline and 90 days after surgery | Measurement: Self-reported measure of pain interference, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater pain interference |
Countries
United States
Participant flow
Recruitment details
30 patients were enrolled in the single-arm trial.
Participants by arm
| Arm | Count |
|---|---|
| Prehabilitation: An Individualized, Multi-component Program This single-arm trial was conducted at Beth Israel Deaconess Medical Center (enrollment site) and Hebrew Rehabilitation Center (intervention site) in Boston, Massachusetts, from March 2023 to January 2025. Patients 65 years or older scheduled for major abdominal, gynecological oncologic, urologic, and cardiovascular procedures were eligible. The program included the following components:
1. Physical therapy: Participants received two one-hour individual sessions per week, delivered by a physical therapist at the Hebrew Rehabilitation Center.
2. Nutrition: Participants received a one-hour individual nutritional counseling virtually by a registered dietitian. They were supplied with a protein bar or drink containing 20 grams of protein and instructed to consume daily, preferably within 30 minutes of exercise, to maximize muscle protein synthesis.
3. Meditation: A meditation instructor at the Beth Israel Deaconess Medical Center Sadhguru Center for a Conscious Planet led a weekly one-hour virtual group meditation session. These sessions focused on breathing techniques and mindfulness practices to alleviate psychological stress, manage anxiety, and promote mental well-being. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Prehabilitation: An Individualized, Multi-component Program |
|---|---|
| Age, Continuous | 75.3 years STANDARD_DEVIATION 6.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 28 |
| other Total, other adverse events | 7 / 28 |
| serious Total, serious adverse events | 1 / 28 |
Outcome results
Primary
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).
Time frame: Post-intervention (up to 4 weeks)
Population: This was calculated in 28 patients who initiated the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | Feasibility of the Prehabilitation Program | 19 Participants |
Secondary
Adherence to Exercise
Measurement: percentage of physical therapy sessions attended Range: 0-100% (higher values indicate better adherence)
Time frame: Post-intervention (up to 4 weeks)
Population: This was calculated in 28 patients who initiated the intervention.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Prehabilitation | Adherence to Exercise | 190 Number of Sessions |
Secondary
Adherence to Meditation
Measurement: percentage of meditation sessions attended Range: 0-100% (higher values indicate better adherence)
Time frame: Post-intervention (up to 4 weeks)
Population: This was calculated in 28 patients who initiated the intervention.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Prehabilitation | Adherence to Meditation | 71 Number of Sessions |
Secondary
Adherence to Nutrition
Measurement: percentage of nutrition sessions attended Range: 0-100% (higher values indicate better adherence)
Time frame: Post-intervention (up to 4 weeks)
Population: This was calculated in 28 patients who initiated the intervention.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Prehabilitation | Adherence to Nutrition | 80 Number of Sessions |
Secondary
Adverse Events
Measurement: percentage of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Population: This was calculated in 28 patients who initiated the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | Adverse Events | 8 Participants |
Secondary
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.
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Population: This was calculated in 25 patients who initiated the intervention and had the post-intervention measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in 5-chair Stand Test Time | -3.4 Seconds |
Secondary
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
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Population: This was calculated in 25 patients who initiated the intervention and had the post-intervention measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Dominant Handgrip Strength | 1.6 Kilograms |
Other Pre-specified
30-day Mortality From All Causes
Measurement: proportion of patients who died within 30 days of surgery
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | 30-day Mortality From All Causes | 0 Participants |
Other Pre-specified
30-day Readmission From All Causes
Measurement: percentage of patients who were readmitted within 30 days of surgery
Time frame: Between surgery and 1 month after surgery
Population: This was calculated in 23 patients who initiated the intervention and underwent surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | 30-day Readmission From All Causes | 3 Participants |
Other Pre-specified
3-D Confusion Assessment Method
Measurement: percentage of patients who develop delirium according to 3-D Confusion Assessment Method within 3 days of surgery
Time frame: Between postoperative day 1 and day 3
Population: This was calculated in 23 patients who initiated the intervention and underwent surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | 3-D Confusion Assessment Method | 0 Participants |
Other Pre-specified
90-day Mortality From All Causes
Measurement: percentage of patients who died within 90 days of surgery
Time frame: Between surgery and 90 days after surgery
Population: This was calculated in 23 patients who initiated the intervention and underwent surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | 90-day Mortality From All Causes | 1 Participants |
Post Hoc
Change in Gait Speed
Measurement: gait speed (meters/second) over 5-meter fast walk, post-intervention minus pre-intervention baseline Range: 0 to 2 meter/second Interpretation: Higher values indicate faster gait.
Time frame: Between pre-intervention baseline and post-intervention (up to 4 weeks)
Population: This was calculated in 25 patients who initiated the intervention and had the post-intervention measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Gait Speed | 0.2 meter/second |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Anxiety T Score
Measurement: Self-reported measure of anxiety, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater anxiety
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Anxiety T Score | -6.4 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Depression T Score
Measurement: Self-reported measure of depression, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate more depressive mood
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Depression T Score | -2.6 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Fatigue T Score
Measurement: Self-reported measure of fatigue, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate worse fatigue
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Fatigue T Score | -4.8 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Intensity Score
Measurement: Self-reported measure of pain intensity, 90 days after surgery minus pre-intervention baseline Range: 0 to 10 Interpretation: Higher scores indicate greater pain intensity
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Intensity Score | -1.4 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Interference T Score
Measurement: Self-reported measure of pain interference, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater pain interference
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Interference T Score | -6.1 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Physical Function T Score
Measurement: Self-reported measure of physical function, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate better physical function
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Physical Function T Score | 4.4 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Sleep Disturbance T Score
Measurement: Self-reported measure of sleep disturbance, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater sleep disturbance
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Sleep Disturbance T Score | -3.0 score on a scale |
Other Pre-specified
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Social Roles/Activities Participation T Score
Measurement: Self-reported measure of participation in social roles/activities, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater participation in social roles/activities
Time frame: Between pre-intervention baseline and 90 days after surgery
Population: This was calculated in 22 patients who initiated the intervention and had the 90-day measurement after surgery.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Prehabilitation | Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Social Roles/Activities Participation T Score | 1.6 score on a scale |
Other Pre-specified
Comprehensive Complication Index
Measurement: a composite complication grading system by Clavien-Dindo Classification (CDC) after an intervention Range: 0 (no complications) to 100 (death) Interpretation: Higher scores indicate more severe complications
Time frame: 1 month after surgery
Population: This was calculated in 23 patients who initiated the intervention and underwent surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prehabilitation | Comprehensive Complication Index | 8.7 score on a scale |
Other Pre-specified
Length of Stay
Measurement: Number of hospital days from surgery until discharge
Time frame: Between surgery and 1 month after surgery
Population: This was calculated in 23 patients who initiated the intervention and underwent surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prehabilitation | Length of Stay | 2 days |