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

NCT ID: NCT04281849

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-09-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

BAMS-HF Program

Group Type: EXPERIMENTAL

BAMS-HF Program

Intervention Type: 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.

Interventions

BAMS-HF Program

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

VA Eastern Colorado Health Care System

FED

Sponsor Role: lead

Responsible Party

Kelsey Flint

Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

1R03AG064371-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-1783

Identifier Type: -

Identifier Source: org_study_id