Post-acute Multicomponent Frailty Intervention

NCT ID: NCT05906446

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Frailty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Multicomponent (Exercise + Protein Supplementation)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebrew SeniorLife

OTHER

Sponsor Role lead

Responsible Party

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Sandra Shi

Instructor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra Shi, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Locations

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Hebrew Rehabilitation Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00068129

Identifier Type: -

Identifier Source: org_study_id