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

NCT04281849 | Completed DMC

• 2 other identifiers: 19-17831R03AG064371-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruiting patients into the study

  Number of patients enrolled in the study each month

  Monthly, up to 30 months

• Acceptability of the intervention to patients randomized to the intervention arm

  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.

  At the end of the intervention period for each patient (week 12 or at time of study dropout)

• Feasibility of the protocol for patients randomized to the intervention arm

  Proportion of prescribed sessions that were actually performed

  At the end of the intervention period for each patient (week 12 or at time of study dropout)

Secondary Outcomes (1)

• 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

Study Arms (2)

Usual care

NO INTERVENTION

Patients in the usual care arm will receive educational material from the Heart Failure Society of America (HFSA) with the current recommendations for exercise for patients with heart failure.

BAMS-HF Program

EXPERIMENTAL

Behavioral: BAMS-HF Program

Interventions

BAMS-HF Program BEHAVIORAL

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.

BAMS-HF Program

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 24, 2020
• Study Start: June 15, 2020
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)