Post-acute Multicomponent Frailty Intervention

Study Overview
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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.

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

Conditions
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Frailty

Intervention / Treatment
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* Other: Multicomponent (Exercise + Protein Supplementation)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation | Other: Multicomponent (Exercise + Protein Supplementation)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Estimated average <1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed | Walking speed measured in m/s | Discharge (on average between 2-3 weeks) | 
| Grip Strength | Dominant Hand Grip Strength measured in Kg (higher values indicate better performance) | 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. | 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. | Discharge (on average at 2-3 weeks) | 
| Adherence to exercise | Proportion of sessions with ≥15 minutes of exercise during the intervention period Range: 0-100% (higher values indicate better adherence) | Entire study period (on average over 2-3 weeks) | 
| 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) | Entire study period (on average over 2-3 weeks) |