Clinical trial NCT04281849: Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program
Official title: Pilot Study of a Moderate- to High-Intensity Home-based Rehabilitation Program in Older Adults Hospitalized for Heart Failure: The Balance, Aerobic Capacity, Mobility and Strength (BAMS-HF) Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-02-24
Enrollment: 29
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 55 years old or older
* Hospitalized for HF or with HF as an active problem during hospitalization
* SPPB \>/=10

Exclusion Criteria:

* Irreversible orthopedic or neurologic disease that severely limits mobility
* Active cancer diagnosis except non-melanoma skin cancer
* Dementia
* Life expectancy of \< 6 months
* Uncontrolled/untreated ventricular tachycardia or ventricular fibrillation
* Advanced heart failure with expectation of left ventricular assist device or transplant in the next 6 months
* Any major surgery in the past 30 days or planned in the next 10 weeks
* Discharge to a skilled nursing facility and/or home with home healthcare physical therapy (home health care nurse or occupational therapist is ok)

Primary outcomes:
measure: Feasibility of recruiting patients into the study
timeFrame: Monthly, up to 30 months
measure: Acceptability of the intervention to patients randomized to the intervention arm
timeFrame: At the end of the intervention period for each patient (week 12 or at time of study dropout)
measure: Feasibility of the protocol for patients randomized to the intervention arm
timeFrame: At the end of the intervention period for each patient (week 12 or at time of study dropout)
Secondary outcomes:
measure: Change in Short Physical Performance Battery, which is scored from 0-16, with higher numbers indicating better functional status
timeFrame: At the end of 12 weeks of study enrollment for each patient
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
Study officials:
References: