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Completed

NCT Number: NCT05906446

Post-acute Multicomponent Frailty Intervention

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

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew Rehabilitation Center

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Gait Speed

    Time frame: Discharge (on average between 2-3 weeks)

    Walking speed measured in m/s

  2. Grip Strength

    Time frame: Discharge (on average at 2-3 weeks)

    Dominant Hand Grip Strength measured in Kg (higher values indicate better performance)

  3. The Patient Reported Outcomes Measurement Information System (PROMIS Global Health v1.2)

    Time frame: 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.

  4. Modified Barthel Index

    Time frame: 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.

  5. Adherence to exercise

    Time frame: Entire study period (on average over 2-3 weeks)

    Proportion of sessions with exercise during the intervention period

    Range: 0-100% (higher values indicate better adherence)

  6. Adherence to supplementation

    Time frame: 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 outcomes

  1. Length of stay

    Time frame: Entire study period (on average over 2-3 weeks)

    Length of admission to SNF

  2. Hospital readmission

    Time frame: Entire study period (on average over 2-3 weeks)

    Proportion of participants who are readmitted to the hospital during SNF stay

  3. Community Discharge

    Time frame: Entire study period (on average over 2-3 weeks)

    Proportion of participants who are discharged to the community from SNF stay

  4. Falls

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study title

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

Acronym: FIT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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