Post-acute Multicomponent Frailty Intervention

NCT05906446 | Completed

• 1 other identifier: Pro00068129
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Gait Speed

  Discharge (on average between 2-3 weeks)

• Grip Strength

  Discharge (on average at 2-3 weeks)

• The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)

  Discharge (on average at 2-3 weeks)

• Modified Barthel Index

  Discharge (on average at 2-3 weeks)

• Adherence to exercise

  Entire study period (on average over 2-3 weeks)

Other Outcomes (4)

• Length of stay

  Entire study period (on average over 2-3 weeks)

• Hospital readmission

  Entire study period (on average over 2-3 weeks)

• Community Discharge

  Entire study period (on average over 2-3 weeks)

Study Arms (1)

Intervention

EXPERIMENTAL

Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation

Other: Multicomponent (Exercise + Protein Supplementation)

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew Rehabilitation Center

Boston, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sandra Shi, MD MPH

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)