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Clinical Trials/NCT05906446
NCT05906446
Completed
N/A

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

Hebrew SeniorLife1 site in 1 country50 target enrollmentJune 15, 2023
ConditionsFrailty

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
Hebrew SeniorLife
Enrollment
50
Locations
1
Primary Endpoint
Feasibility of the Intervention
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
October 31, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hebrew SeniorLife
Responsible Party
Principal Investigator
Principal Investigator

Sandra Shi

Instructor of Medicine

Hebrew SeniorLife

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility of the Intervention

Time Frame: Estimated average <1 month

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).

Secondary Outcomes

  • Adherence to supplementation(Entire study period (on average over 2-3 weeks))
  • 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))

Study Sites (1)

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