Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program
Condition: Heart Failure; Heart Failure With Preserved Ejection Fraction; Heart Failure, Systolic; Heart Failure, Diastolic; Heart Failure，Congestive; Heart Failure; With Decompensation; Heart Failure Acute; Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      This is a pilot randomized trial of the BAMS-HF (Balance, Aerobic capacity, Mobility and
      Strength in patients hospitalized for Heart Failure) Program versus usual care. The BAMS-HF
      Program pilot study is an initial step in eventually creating a comprehensive,
      patient-centered, primarily home-based rehabilitation intervention aimed at preventing
      worsening disability and dependence among older adults hospitalized for HF. The BAMS-HF
      Program will enroll patients hospitalized for HF (or with HF as an active problem during
      hospitalization) within the past 4 weeks and will engage patients during the vulnerable
      post-discharged period. The objective of this pilot study is to test the feasibility,
      acceptability and preliminary effect of the BAMS-HF Program in older (>/= 65 years) adults
      hospitalized for HF. The BAMS-HF Program will begin within 4 week of hospital discharge and
      be administered 3 times weekly for 12 weeks in the patient's home upon discharge. Patients
      who are able to safely complete the program without in-person assistance will transition to
      telehealth (aka telerehabilitation) visits. The BAMS-HF Program is innovative because it is
      home-based, and will utilize rigorous, progressive exercises across multiple domains of
      physical function. The estimated preliminary effect size will be measured with the Short
      Physical Performance Battery (SPPB), a well-validated measure that predicts incident
      mobility/disability and falls in the geriatric population.

      Aim #1: To assess the feasibility of the BAMS-HF Program by measuring 1) study enrollment
      rate, 2) proportion of prescribed sessions that were actually performed, 3) proportion of
      patients completing full baseline assessment and outcome measures

      Aim #2: To assess the acceptability of the BAMS-HF Program with qualitative interviews of
      participants in the intervention arm that will ask about their experience in the program, any
      aspects of the intervention they recommend changing and whether patients would recommend the
      program to others. Reason for declining or stopping participation in the study will also be
      recorded and considered in adjusting the study protocol.

      Aim #3: To estimate the preliminary intervention effect by investigating the difference in
      change in SPPB between the BAMS-HF Program arm and the usual care arm.
    


Intervention name(s): BAMS-HF Program
Intervention type(s): Behavioral
Intervention description(s): BAMS-HF Program (intervention) arm will consist of 3 in-home sessions (45-60 min ea) per week for 12 weeks with the study physical therapist. The study physical therapist will transition appropriate participants to virtual in-home visits (i.e. telerehabilitation) for some visits. The study physical therapist will design individualized exercise programs first targeting strength, then mobility and balance, and finally, aerobic capacity. Exercises will be progressive, with the goal of an 8 repetition maximum for each strength component, 80% completion rate for balance/mobility components and targeting a moderate rate of perceived exertion for aerobic components.
Interviews: There will be a recorded interview after the last session of the study to get participants' opinion of the program, suggestions for improvement and description of any barriers to participating in the program fully.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment