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

Primary Purpose

Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure, Systolic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BAMS-HF Program
Sponsored by
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rocky Mountain Regional VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

BAMS-HF Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of recruiting patients into the study
Number of patients enrolled in the study each month
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.
Feasibility of the protocol for patients randomized to the intervention arm
Proportion of prescribed sessions that were actually performed

Secondary Outcome Measures

Change in Short Physical Performance Battery, which is scored from 0-16, with higher numbers indicating better functional status
Estimate the preliminary effect of the BAMS-HF Program on change in the Short Physical Performance Battery from baseline to 12 weeks

Full Information

First Posted
February 17, 2020
Last Updated
March 21, 2023
Sponsor
VA Eastern Colorado Health Care System
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04281849
Brief Title
Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program
Acronym
BAMS-HF
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
September 14, 2022 (Actual)
Study Completion Date
September 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Eastern Colorado Health Care System
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Arm Title
BAMS-HF Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
BAMS-HF Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruiting patients into the study
Description
Number of patients enrolled in the study each month
Time Frame
Monthly, up to 30 months
Title
Acceptability of the intervention to patients randomized to the intervention arm
Description
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.
Time Frame
At the end of the intervention period for each patient (week 12 or at time of study dropout)
Title
Feasibility of the protocol for patients randomized to the intervention arm
Description
Proportion of prescribed sessions that were actually performed
Time Frame
At the end of the intervention period for each patient (week 12 or at time of study dropout)
Secondary Outcome Measure Information:
Title
Change in Short Physical Performance Battery, which is scored from 0-16, with higher numbers indicating better functional status
Description
Estimate the preliminary effect of the BAMS-HF Program on change in the Short Physical Performance Battery from baseline to 12 weeks
Time Frame
At the end of 12 weeks of study enrollment for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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