Post-acute Multicomponent Frailty Intervention

Frailty Clinical Trial

— FIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906446
• Other study ID #: Pro00068129
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Hebrew SeniorLife
• Contact: Sandra Shi, MD MPH
• Phone: (617) 971-5324
• Email: sandrashi[@]hsl.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew SeniorLife

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	Length of admission to SNF	Entire study period (on average over 2-3 weeks)
Other	Hospital readmission	Proportion of participants who are readmitted to the hospital during SNF stay	Entire study period (on average over 2-3 weeks)
Other	Community Discharge	Proportion of participants who are discharged to the community from SNF stay	Entire study period (on average over 2-3 weeks)
Other	Falls	Proportion of participants who experience a fall, as documented in the medical record, during SNF stay	Entire study period (on average over 2-3 weeks)
Primary	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	Gait Speed	Walking speed measured in m/s	Discharge (on average between 2-3 weeks)
Secondary	Grip Strength	Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)	Discharge (on average at 2-3 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)