Health TrialsbyHealthPanel

Supplemental Mobility

ConditionsAgingFunctional RecoverySkilled Nursing FacilityMedically ComplexDeconditioning
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Colorado, Denver

About this trial

This pilot study will evaluate the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization. STAMP will be administered by a mobility aide who will support patients in increasing physical activity through walking and transfers outside of structured rehabilitation. Participants will either receive high-intensity rehabilitation (HIR) or usual care rehabilitation, combined with STAMP. The two main aims are: 1) determine the feasibility, acceptability, and safety of STAMP, and 2) evaluate the feasibility and variability of patient physical function outcome measures. The study will provide preliminary data on program delivery and safety to inform the design of a larger trial aimed at identifying the most effective strategies to optimize functional recovery in SNFs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 50 years old

Admitted to SNF from the hospital

Ambulatory at admission with minimal assistance or less

Disqualifiers

Contraindications to high-intensity resistance training (per American College of Sports Medicine Exercise Testing and Prescription)

Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's disease, traumatic brain injury)

Lower extremity weight-bearing precautions that require greater than minimal assistance with ambulation

Subsequent SNF admission

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Intensity Rehabilitation

    Other intervention

    An 8RM is the dose necessary for most effective strength gains in community-dwelling older adults, and is equivalent to 80% of a one repetition max, which is the maximal load needed to voluntarily complete one repetition of a given exercise with proper form. Activities will include strength training, transfer practice, balance training, advanced ADLs. Clinicians will tailor the intervention for each activity to target overload using 8-repetition maximum for resistance training. Other interventions will be performed to muscle failure or inability to complete the final repetition. Failure is the inability to complete a repetition through the full, available range of motion without significant compensation. Further, high-intensity dosing requires continuous, volitional effort from the patient; therefore, incorporation of motivational interviewing strategies across sessions will maximize patient effort and self-efficacy.

  • Safe Transfers and Mobility Program

    Other intervention

    The Safe Transfers and Mobility Program (STAMP) embeds a mobility aide into daily care. STAMP is a patient-centered, scalable approach to extend the benefits of rehabilitation sessions by increasing mobility throughout the day and reinforcing activity between therapy sessions. Core components are: (1) targeting 45 minutes of additional daily physical activity through support with walking and functional mobility tasks; (2) establishing individualized mobility goals collaboratively set by the therapist and patient, based on functional level; (3) delivering progressive activities with walking distances increased by \~30% weekly, adjusted for patient tolerance; and (4) interdisciplinary coordination to incorporate STAMP sessions into routine care with minimal disruption to clinical workflow. Prior work suggests that 45 minutes of STAMP can at least double daily step counts, and increasing walking distance by 30% per week is feasible even for individuals with low baseline function.

  • Usual Care

    Other intervention

    Usual Care SNFs will continue with routine collection and documentation of physical performance outcomes (gait speed, SPPB, Modified Barthel ADL Index) as standard practice. Importantly, the Usual Care SNF including the facility, rehabilitation clinicians, and patients will not have access to i-STRONGER materials.

Treatment groups

192 Participants
are divided into 4 treatment groups
Group A: Usual CareActive comparator 1 intervention
Group B: High Intensity RehabilitationExperimental treatment 1 intervention
Group C: Usual Care and STAMPExperimental treatment 2 interventions
Group D: High Intensity Rehabilitation and STAMPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Usual Gait Speed

Gait speed will be measured in meters/second using the time it takes to walk a 4-meter path at usual speed using a stopwatch. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher gait speed indicates better outcome.

Time frame
Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days

Secondary outcomes

1

Feasibility of Intervention Measure (FIM)

Feasibility of Intervention (FIM) will be collected from SNF Providers to assess feasibility. The FIM is a 4-item survey rated on a 5-point Likert scale (1=completely disagree to 5=completely agree), with higher average scores indicating greater feasibility.

Time frame
At end of STAMP phase, approximately 8 months
2

STAMP Session Adherence Rate

Of all enrolled patients, percent completing ≥ 80% of sessions attempted by mobility aide

Time frame
Beginning of STAMP phase to end of STAMP phase, approximately 8 months
3

Modified 30 Second Sit to Stand

The Modified 30 second sit to stand test (m30STS) counts the number of stands from a chair completed in 30 seconds, which allows for upper extremity use on the armrests of a chair. The score is the total number of stands completed in 30 seconds; more than halfway up at the end of 30 seconds counts as a stand. Completion rates will be collected. Within site pre- to post- STAMP changes will be assessed. Higher scores indicate better outcomes.

Time frame
Admission into rehabilitation and discharge from rehabilitation, which would be an approximate average of 14 days
4

Number of Rehospitalizations

Number of re-hospitalizations during SNF stay.

Time frame
Up to 8 months of Pre-STAMP phase and 8 months of STAMP phase

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Aegis Therapies, Inc.

Collaborator

Source ClinicalTrials.gov

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