Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program

Not Applicable

Completed

• Conditions: Heart Failure; Heart Failure With Preserved Ejection Fraction; Heart Failure, Diastolic; Heart Failure; With Decompensation; Heart Failure, Systolic; Heart Failure，Congestive; Heart Failure Acute; Heart Failure With Reduced Ejection Fraction
• Interventions: Behavioral: BAMS-HF Program

• Registration Number: NCT04281849
• Lead Sponsor: VA Eastern Colorado Health Care System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-24
• Study Start: 2020-06-15
• Primary Completion: 2022-09-14
• Study Completion: 2022-09-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAMS-HF Program	BAMS-HF Program	-

Primary Outcome Measures

Name	Time	Method
Feasibility of recruiting patients into the study	Monthly, up to 30 months	Number of patients enrolled in the study each month
Acceptability of the intervention to patients randomized to the intervention arm	At the end of the intervention period for each patient (week 12 or at time of study dropout)	Qualitative interviews of participants in the intervention arm 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.
Feasibility of the protocol for patients randomized to the intervention arm	At the end of the intervention period for each patient (week 12 or at time of study dropout)	Proportion of prescribed sessions that were actually performed

Secondary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery, which is scored from 0-16, with higher numbers indicating better functional status	At the end of 12 weeks of study enrollment for each patient	Estimate the preliminary effect of the BAMS-HF Program on change in the Short Physical Performance Battery from baseline to 12 weeks

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center; 🇺🇸 Aurora, Colorado, United States