FIT: Post-acute Multicomponent Frailty Intervention
Study Details
Study Description
Brief Summary
The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation |
Other: 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
|
Outcome Measures
Primary Outcome Measures
- Feasibility of the Intervention [Estimated average <1 month]
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 [Discharge (on average between 2-3 weeks)]
Walking speed measured in m/s
- Grip Strength [Discharge (on average at 2-3 weeks)]
Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)
- The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2) [Discharge (on average at 2-3 weeks)]
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 [Discharge (on average at 2-3 weeks)]
Assessment of functional disability based on 10 activities of daily life (ADLs). Range 0-10 with high values indicating better performance.
- Adherence to exercise [Entire study period (on average over 2-3 weeks)]
Proportion of sessions with ≥15 minutes of exercise during the intervention period Range: 0-100% (higher values indicate better adherence)
- Adherence to supplementation [Entire study period (on average over 2-3 weeks)]
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)
Other Outcome Measures
- Length of stay [Entire study period (on average over 2-3 weeks)]
Length of admission to SNF
- Hospital readmission [Entire study period (on average over 2-3 weeks)]
Proportion of participants who are readmitted to the hospital during SNF stay
- Community Discharge [Entire study period (on average over 2-3 weeks)]
Proportion of participants who are discharged to the community from SNF stay
- Falls [Entire study period (on average over 2-3 weeks)]
Proportion of participants who experience a fall, as documented in the medical record, during SNF stay
Eligibility Criteria
Criteria
Inclusion Criteria:
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Community-dwelling before hospitalization
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Age ≥ 65 years
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Admitted to SNF directly from inpatient hospitalization
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English speaking
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Mild Frailty or worse, as measured by a Clinical Frailty Scale
Exclusion Criteria:
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Discharged from Emergency Department
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Non-community discharge plan on admission (e.g. plan to discharge to hospice)
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Nothing per oral (NPO) dietary status
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Presence of any feeding tube
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Chronic kidney disease stage IV or worse
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Clinician refusal
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Inability or refusal to consume intervention products (e.g. allergies to protein supplement)
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Inability to consent to study procedures
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hebrew SeniorLife
Investigators
- Principal Investigator: Sandra Shi, MD MPH, Hebrew SeniorLife
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00068129