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Post-acute Multicomponent Frailty Intervention (FIT)

Primary Purpose

Frailty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multicomponent (Exercise + Protein Supplementation)
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Feasibility of the Intervention
    Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, 2) the proportion of participants adherent to the intervention, and 3) the proportion lost to follow-up after three weeks of intervention. Feasibility is defined as at least 70% of eligible patients are successfully enrolled and complete the full intervention (receiving ≥80% of sessions). Range: 0-100% (higher values indicate higher feasibility).

    Secondary Outcome Measures

    Gait Speed
    Walking speed measured in m/s
    Grip Strength
    Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)
    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.
    Modified Barthel Index
    Assessment of functional disability based on 10 activities of daily life (ADLs). Range 0-10 with high values indicating better performance.
    Adherence to exercise
    Proportion of sessions with ≥15 minutes of exercise during the intervention period Range: 0-100% (higher values indicate better adherence)
    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)

    Full Information

    First Posted
    June 1, 2023
    Last Updated
    June 21, 2023
    Sponsor
    Hebrew SeniorLife
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05906446
    Brief Title
    Post-acute Multicomponent Frailty Intervention
    Acronym
    FIT
    Official Title
    Feasibility of a Multicomponent Frailty Intervention During Post-acute Rehabilitation in Skilled Nursing Facilities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hebrew SeniorLife

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frailty

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation
    Intervention Type
    Other
    Intervention Name(s)
    Multicomponent (Exercise + Protein Supplementation)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Feasibility of the Intervention
    Description
    Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, 2) the proportion of participants adherent to the intervention, and 3) the proportion lost to follow-up after three weeks of intervention. Feasibility is defined as at least 70% of eligible patients are successfully enrolled and complete the full intervention (receiving ≥80% of sessions). Range: 0-100% (higher values indicate higher feasibility).
    Time Frame
    Estimated average <1 month
    Secondary Outcome Measure Information:
    Title
    Gait Speed
    Description
    Walking speed measured in m/s
    Time Frame
    Discharge (on average between 2-3 weeks)
    Title
    Grip Strength
    Description
    Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)
    Time Frame
    Discharge (on average at 2-3 weeks)
    Title
    The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)
    Description
    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)
    Title
    Modified Barthel Index
    Description
    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)
    Title
    Adherence to exercise
    Description
    Proportion of sessions with ≥15 minutes of exercise during the intervention period Range: 0-100% (higher values indicate better adherence)
    Time Frame
    Entire study period (on average over 2-3 weeks)
    Title
    Adherence to supplementation
    Description
    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)
    Time Frame
    Entire study period (on average over 2-3 weeks)
    Other Pre-specified Outcome Measures:
    Title
    Length of stay
    Description
    Length of admission to SNF
    Time Frame
    Entire study period (on average over 2-3 weeks)
    Title
    Hospital readmission
    Description
    Proportion of participants who are readmitted to the hospital during SNF stay
    Time Frame
    Entire study period (on average over 2-3 weeks)
    Title
    Community Discharge
    Description
    Proportion of participants who are discharged to the community from SNF stay
    Time Frame
    Entire study period (on average over 2-3 weeks)
    Title
    Falls
    Description
    Proportion of participants who experience a fall, as documented in the medical record, during SNF stay
    Time Frame
    Entire study period (on average over 2-3 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra Shi, MD MPH
    Phone
    (617) 971-5324
    Email
    sandrashi@hsl.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandra Shi, MD MPH
    Organizational Affiliation
    Hebrew SeniorLife
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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