Post-acute Multicomponent Frailty Intervention (FIT)

Feasibility of a Multicomponent Frailty Intervention During Post-acute Rehabilitation in Skilled Nursing Facilities

The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: Multicomponent (Exercise + Protein Supplementation)

Detailed Description

The frailty intervention includes frequent short exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation, delivered on top of usual care in the post-acute Skilled Nursing Facility (SNF) setting. There is no control group.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Hebrew Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Community-dwelling before hospitalization
• Age ≥ 65 years
• Admitted to SNF directly from inpatient hospitalization
• English speaking
• Mild Frailty or worse, as measured by a Clinical Frailty Scale

Exclusion Criteria:

• Discharged from Emergency Department
• Non-community discharge plan on admission (e.g. plan to discharge to hospice)
• Nothing per oral (NPO) dietary status
• Presence of any feeding tube
• Chronic kidney disease stage IV or worse
• Clinician refusal
• Inability or refusal to consume intervention products (e.g. allergies to protein supplement)
• Inability to consent to study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation	Other: Multicomponent (Exercise + Protein Supplementation); Exercises selected from a pre-specified list, reassessed weekly; Participants will receive individualized exercise sessions, (e.g. 15-30 minutes per session, one session per day, offered five times a week); Participants will also be offered a protein supplement within 30 min of exercise.; Sessions will be supervised

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Intervention	Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, and 2) the proportion of participants adherent to the intervention Range: 0-100% (higher values indicate higher feasibility).	Estimated average <1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed	Walking speed measured in m/s	Discharge (on average between 2-3 weeks)
Grip Strength	Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)	Discharge (on average at 2-3 weeks)
The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)	The PROMIS Scale v1.2 - Global Health (also referred to as PROMIS-10) is a ten-item patient reported measure of physical, mental and social health. Items query general health, quality of life, physical health, mental health, satisfaction with discretionary social activities, carrying out every day physical activities, pain, fatigue, satisfaction with social roles, and emotional problems (Hays et al., 2009). Physical Health (physical health, physical function, pain, and fatigue items) and Mental Health (quality of life, mental health, satisfaction with discretionary social activities, and emotional problem items) (Hays et al., 2009). T scores for both Physical and Mental Health scales.	Discharge (on average at 2-3 weeks)
Modified Barthel Index	Assessment of functional disability based on 10 activities of daily life (ADLs). Range 0-10 with high values indicating better performance.	Discharge (on average at 2-3 weeks)
Adherence to supplementation	Proportion of oral nutritional supplement consumed over the total number of supplements during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)	Entire study period (on average over 2-3 weeks)
Adherence to exercise	Proportion of sessions with exercise during the intervention period Range: 0-100% (higher values indicate better adherence)	Entire study period (on average over 2-3 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of admission to SNF	Entire study period (on average over 2-3 weeks)
Hospital readmission	Proportion of participants who are readmitted to the hospital during SNF stay	Entire study period (on average over 2-3 weeks)
Community Discharge	Proportion of participants who are discharged to the community from SNF stay	Entire study period (on average over 2-3 weeks)
Falls	Proportion of participants who experience a fall, as documented in the medical record, during SNF stay	Entire study period (on average over 2-3 weeks)

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife
• Investigators: Principal Investigator: Sandra Shi, MD MPH, Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: Pro00068129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No