Post-acute Multicomponent Frailty Intervention

Hebrew SeniorLife50 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Frailty

Interventions

Multicomponent (Exercise + Protein Supplementation)OTHER

* 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

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hebrew Rehabilitation Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: Estimated average <1 month

Secondary Outcomes

Gait Speed

Walking speed measured in m/s

Time frame: Discharge (on average between 2-3 weeks)

Grip Strength

Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)

Time frame: 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.

Time frame: 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.

Time frame: Discharge (on average at 2-3 weeks)

Adherence to exercise

Data from ClinicalTrials.gov

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