Heart FailureBAMS-HFNCT04281849
Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program
A study testing BAMS-HF Program in people with Heart Failure and Heart Failure With Preserved Ejection Fraction, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure, Systolic
- What is being tested?
- BAMS-HF Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years old or older
- Hospitalized for HF or with HF as an active problem during hospitalization
- SPPB >/=10
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
About this study
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.
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
Read more
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
- Being tested
- BAMS-HF Program
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAMS-HF ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Behavioral: BAMS-HF Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting patients into the study
Number of patients enrolled in the study each month
Measured: 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.
Measured: 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
Measured: 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
Estimate the preliminary effect of the BAMS-HF Program on change in the Short Physical Performance Battery from baseline to 12 weeks
Measured: At the end of 12 weeks of study enrollment for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start15 Jun 2020
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kelsey Flint, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281849
- Sponsor's protocol ID
- 19-1783
- Other IDs
- 1R03AG064371-01
- Acronym
- BAMS-HF
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04281849
- Acronym / sponsor ID
- BAMS-HF / 19-1783
- Conditions
- Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure，Congestive, Heart Failure; With Decompensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 55 years old or older
- Hospitalized for HF or with HF as an active problem during hospitalization
- SPPB >/=10
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAMS-HF ProgramBAMS-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. | Behavioural | BAMS-HF Program |
Primary outcome
Feasibility of recruiting patients into the study
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Change in Short Physical Performance Battery, which is scored from 0-16, with higher numbers indicating better functional status
Time frame: At the end of 12 weeks of study enrollment for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAMS-HF Program in people with Heart Failure and Heart Failure With Preserved Ejection Fraction, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting patients into the study (time frame: Monthly, up to 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.