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Completed

NCT Number: NCT04300413

Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility

During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time.

HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Community Living Center at Fitzsimmons

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults over 50 who are admitted to a skilled nursing facility following hospitalization
  • Qualify to receive at least physical therapy services
  • Ambulatory prior to hospitalization

Exclusion criteria

  • Patients with neurological disorders such as acute stroke or acute traumatic brain injury
  • Patients on hospice care
  • Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):
  • Recent unstable fracture
  • Advanced congestive heart failure
  • Bone metastasis sites
  • Tumors in strengthening target areas
  • Acute Illness
  • Recent myocardial infarction (within 3-6 weeks)
  • Weight bearing restrictions on graft or fracture sites
  • Exposed tendon or muscle
  • Absence of pedal pulses
  • Presence of fistula
  • Platelet levels <50,000/μL
  • Weight-bearing precautions and inability to ambulate prior to hospitalization

Treatment and study plan

High-Intensity Rehabilitation plus Mobility (HeRo)

Other

Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.

Primary outcomes

  1. Gait Speed

    Time frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days

    Time it takes to walk 4 meters (meters per second)

Secondary outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days

    Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests

Other outcomes

  1. Patient Satisfaction Survey

    Time frame: At date of discharge after their stay in the Skilled Nursing Facility, (approximately 21 days after admission).

    8 question survey on patient satisfaction, scoring each question on a 1-10 scale (1=not at all and 10=extremely)

  2. Physical Activity (upright time)

    Time frame: Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).

    Percent waking hours spent upright measured using ActivPAL devices

  3. Physical Activity (sedentary time)

    Time frame: Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).

    Time spent in sedentary bouts measured using ActivPAL devices

  4. Treatment fidelity

    Time frame: At least 2 observations per provider per year throughout duration of study (approximately 2 years), 2 additional observations scheduled if compliance is <80% on objective fidelity checklist.

    Provider intervention compliance with high-intensity rehabilitation (PT and OT) and mobility (nursing staff) using a fidelity checklist

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2020
Registry last updated
Jul 13, 2022

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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