FrailtyFITNCT05906446
Post-acute Multicomponent Frailty Intervention
A study testing Multicomponent (Exercise + Protein Supplementation) in people with Frailty, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Multicomponent (Exercise + Protein Supplementation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Boston, Massachusetts, 02131
About this study
Official title: Feasibility of a Multicomponent Frailty Intervention During Post-acute Rehabilitation in Skilled Nursing Facilities
The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.
Read the 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.
- Conditions
- Frailty
- Being tested
- Multicomponent (Exercise + Protein Supplementation)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent (Exercise + Protein Supplementation)Other
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation Receives: Other: Multicomponent (Exercise + Protein Supplementation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, and 2) the proportion of participants adherent to the intervention
Range: 0-100% (higher values indicate higher feasibility).
Measured: Estimated average <1 month
Secondary outcomes (6)
Gait Speed
Walking speed measured in m/s
Measured: Discharge (on average between 2-3 weeks)
Grip Strength
Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)
Measured: 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.
Measured: 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.
Measured: Discharge (on average at 2-3 weeks)
Adherence to exercise
Proportion of sessions with exercise during the intervention period
Range: 0-100% (higher values indicate better adherence)
Measured: 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)
Measured: Entire study period (on average over 2-3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Shi, Hebrew SeniorLife
- Investigators
- Sandra Shi, MD MPH, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906446
- Sponsor's protocol ID
- Pro00068129
- Acronym
- FIT
- Status last verified
- Apr 2025
- First submitted
- 1 Jun 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multicomponent Frailty Intervention During Post-acute Rehabilitation in Skilled Nursing Facilities
- ClinicalTrials.gov ID
- NCT05906446
- Acronym / sponsor ID
- FIT / Pro00068129
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multicomponent (Exercise + Protein Supplementation)Regular exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention |
Primary outcome
Feasibility of the Intervention
Time frame: Estimated average <1 month
Feasibility will be determined by assessing 1) the proportion of eligible patients enrolled, and 2) the proportion of participants adherent to the intervention Range: 0-100% (higher values indicate higher feasibility).
6 secondary outcomes
Gait Speed
Time frame: Discharge (on average between 2-3 weeks)
Grip Strength
Time frame: Discharge (on average at 2-3 weeks)
The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)
Time frame: Discharge (on average at 2-3 weeks)
Modified Barthel Index
Time frame: Discharge (on average at 2-3 weeks)
Adherence to exercise
Time frame: Entire study period (on average over 2-3 weeks)
Adherence to supplementation
Time frame: Entire study period (on average over 2-3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Shi, MD MPH principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent (Exercise + Protein Supplementation) in people with Frailty, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: Estimated average <1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.