Post-acute Multicomponent Frailty Intervention
- Conditions
- Frailty
- Interventions
- Other: Multicomponent (Exercise + Protein Supplementation)
- Registration Number
- NCT05906446
- Lead Sponsor
- Hebrew SeniorLife
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Multicomponent (Exercise + Protein Supplementation) Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)