Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
NCT ID: NCT03615469
Last Updated: 2023-05-31
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
15 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-09-06
Study Completion Date
2020-12-01
Brief Summary
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In the U.S., 5.7 million people have heart failure (HF), 915,000 new cases are diagnosed each year, and both incidence and prevalence are increasing due to the aging of the population and to better survival from ischemic heart disease. A hallmark of HF, is poor functional status that, characteristically, deteriorates as the condition progresses, negatively affecting patients' quality of life. Poor functional status is associated with increased risk of hospitalization for exacerbations of HF and with increased mortality. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of HF management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing HF symptoms and hospitalizations in patients with HF. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity. In this study, we propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance. NMES has been shown to improve muscle strength, exercise capacity and quality of life, in samples less than 20 of male patients with HF. Larger sample studies are needed to demonstrate efficacy of this practice to jump start patients' abilities to benefit from formalized exercise program. The purpose of this double blinded, randomized, controlled, longitudinal study is to determine if NMES will increase muscle mass and strength, decrease sedentary time, and improve HF symptoms and exercise capacity, thus improving quality of life in patients with HF. It is hypothesized that with this increase in muscle mass, patients will improve overall exercise tolerance and capacity. In addition, after the intervention patients will be better able to tolerate an exercise program thus improving adherence to exercise recommendations. After 6 weeks of intervention, patients will be encouraged to participate in a formalized exercise program.
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Detailed Description
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Conditions
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Heart Failure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a double blinded, randomized controlled longitudinal study design to determine if NMES will increase muscle mass and strength, decrease sitting and lying time, and improve HF symptoms and exercise capacity thus improving likelihood of engagement with a structured exercise program. Patients will be randomized to either intervention that includes NMES or to a sham(TENS)/wait list control group. In order to ensure that the two groups are comparable between treatment and sham interventions, the participants will be randomized according to gender. Randomization via minimization will be used in order to avoid an unbalanced number of women in the two comparison groups due to chance. A file of the computer-generated random assignments will be kept by the research assistant so the PI/data collector remains blinded in a protected Box Health account.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
The PI will collect baseline data before the participant is randomized. The intervention/sham will be set-up by the RA and will be collected after the PI leaves the department so those collecting data will not know which group the participant has been/will be participating in. The RA who is trained in both NMES and Sham intervention will then look at the randomization schedule, and set up and train the participants on equipment use. Once trained, participants will be contacted via phone weekly by the RA who initially trained them (in order to maintain blinding). The RA applying the intervention will not have any part in the data collection of the rest of the measurements (other than adherence, tolerance and problems with equipment).
Study Groups
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Neuromusclar electrical stimulation
NMES will be set up with the machine on simultaneous large muscle atrophy setting with 500 ohm with peak of 50 volts, the "self-adhesive electrodes positioned on the thighs approximately 5 cm below the inguinal fold and 3 cm above the upper patella border" as described by Gobbo. When applying the stimulation, the intensity will be gradually increased from an intermittent tingling until a gentle pumping sensation is felt. Participants will direct the amount of stimulation acceptable on both thighs to improve acceptance of the modality. It is expected that tolerance will develop and intensity will increase over time.
Group Type
ACTIVE_COMPARATOR
Neuromuscular electrical stimulation
Intervention Type
DEVICE
When applying the stimulation, the intensity will be gradually increased from an intermittent tingling until a gentle pumping sensation is felt and muscle contraction is seen. Participants will direct the amount of stimulation acceptable on both thighs to improve acceptance of the modality.10,24,29-31 To assist better tolerance large electrodes (2x4) will be used and participants will also be instructed to be in a seated position with chair close to the wall so that their leg is 90-degree angle and then push against the wall to decrease any uncomfortable feeling during the contraction. 5 sessions per week for 6 weeks done independently at home, with 15 minutes per session (15 minutes per day/session, 15 seconds stimulation on, 15 seconds recovery time) to both legs. We expect the participant to develop tolerance to the treatment and thus increase the intensity of the NMES over time.
Transcutaneous electrical stimulation
For the Sham group, electrodes will follow the same landmarks, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation
Group Type
SHAM_COMPARATOR
Transcutaneous electrical stimulation
Intervention Type
DEVICE
For the Sham group, electrodes will follow the same landmarks, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation. Intensity settings will not change over time.
Interventions
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Transcutaneous electrical stimulation
For the Sham group, electrodes will follow the same landmarks, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation. Intensity settings will not change over time.
Intervention Type
DEVICE
Neuromuscular electrical stimulation
When applying the stimulation, the intensity will be gradually increased from an intermittent tingling until a gentle pumping sensation is felt and muscle contraction is seen. Participants will direct the amount of stimulation acceptable on both thighs to improve acceptance of the modality.10,24,29-31 To assist better tolerance large electrodes (2x4) will be used and participants will also be instructed to be in a seated position with chair close to the wall so that their leg is 90-degree angle and then push against the wall to decrease any uncomfortable feeling during the contraction. 5 sessions per week for 6 weeks done independently at home, with 15 minutes per session (15 minutes per day/session, 15 seconds stimulation on, 15 seconds recovery time) to both legs. We expect the participant to develop tolerance to the treatment and thus increase the intensity of the NMES over time.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Adult patients who have recently been hospitalized for heart failure
* live at home
* are receiving guideline recommended pharmacologic therapy
* do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week).
* live at home
* are receiving guideline recommended pharmacologic therapy
* do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week).
Exclusion Criteria
* Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
* Cognitive or other impairment which prevents accurate application of intervention or inability to provide informed consent
* End Stage Renal Disease or receiving mechanical ventilation
* Receiving non-approved FDA-investigational agents or devices,
* Has received a heart transplant, a destination Ventricular Assist Device (LVAD), pacemaker, or implantable cardiac device
* previously used NMES (Neuromuscular electrical stimulation) or TENS (Transcutaneous electrical nerve stimulation)
* Uncontrolled arrhythmia's or 3 degree AV heart block
* are unable to correctly apply and operate the device even after instruction
* Those with wounds over area of proper placement of electrodes
* Those who are unable to speak and write English.
* Cognitive or other impairment which prevents accurate application of intervention or inability to provide informed consent
* End Stage Renal Disease or receiving mechanical ventilation
* Receiving non-approved FDA-investigational agents or devices,
* Has received a heart transplant, a destination Ventricular Assist Device (LVAD), pacemaker, or implantable cardiac device
* previously used NMES (Neuromuscular electrical stimulation) or TENS (Transcutaneous electrical nerve stimulation)
* Uncontrolled arrhythmia's or 3 degree AV heart block
* are unable to correctly apply and operate the device even after instruction
* Those with wounds over area of proper placement of electrodes
* Those who are unable to speak and write English.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Christine Haedtke, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University
Indianapolis, Indiana, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1801643369
Identifier Type: -
Identifier Source: org_study_id
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