Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)

May 8, 2023 updated by: Indiana University

Building Strength Through Rehabilitation for Heart Failure Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Sham Comparator: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 Minute Walk Test
Time Frame: From Baseline to 5-6 months
The 6-min walk test (6MWT) estimates the person's ability to perform everyday activities by measuring the distance walked in a set time period. It will be used to measure exercise capacity, specific aim 2. Participants will be allowed use of an assistive device and will be instructed to move as quickly as they feel safe and comfortable over the 100-meter course for 6 minutes. As per the protocol, participants will be allowed to stop and rest if necessary. This test is recommended by the American Thoracic Society for patients with moderate to severe heart or lung disease.
From Baseline to 5-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DXA from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Dual-energy x-ray absorptiometry (DXA) will be used to determine if there is a measurable change in fat mass and skeletal muscle mass as a result of NMES intervention (specific aim 1). Total and segmental (bilateral upper leg) body composition will be assessed according to the differential degree of photon attenuation at two levels of energy as described by Steiner.35
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in Physical activity (ActivPal4) from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
ActivPal4 is an accelerometer that also has an inclinometer built in to differentiate between lying/sitting, standing and walking. It will be used to measure physical activity levels (specific aim 2). Patients will be instructed to wear the ActivPal for 7 days continuously during each time point. It is worn on the thigh and placed under a waterproof "bandage". This allows the patient to put it on and forget about it even in the shower.
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in timed up and go test from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
TUG is an objective measure of physical functional. The test measures in seconds how long it takes for someone to, stand up from a chair, walk forward 10 feet, turn around, walk back to the chair, and sit down.64 Reliability was been demonstrated by test-retest interclass correlations of 0.978-0.99 across studies done within 7 days.65 Construct validity is acceptable with the measure demonstrating a specificity ranging from 87-97% and sensitivity from 83-87% for predicting older adults likely to fall.66,67 A reduction in time greater than or equal to 1.4 seconds is a major change and 0.2 is an unimportant change.68
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in strength test (Dynamometer) from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months
Strength Assessment will be done using a portable fixed dynamometer load cell (BTE Technologies, Hanover, MD) (specific aim 1). The load cell will be calibrated prior to testing daily using manufactures guidelines. The patient will be seated with knees flexed to 90° following the protocol described by Toonstra.36 The participant will be seated with inelastic strap just above the ankle to resist knee extension. Participants will be given 5 minutes to familiarize themselves with the device and testing procedures. Practice trials will be performed prior to testing. Participants will be asked to produce 3 maximal contractions for 5 seconds each with a 60 second rest between trials. The average of the 3 contractions will be used to represent strength of the knee extensors. Then isometric tests will be completed.
Baseline, 6-8 weeks after baseline and 5-6 months
Change in repeated sit to stand test from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Repeated Sit to Stand Test is an objective physical test in which the person is asked to rise from a seated position 5 times as quickly as possible. This measures leg strength as well as balance and mobility.59,60
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in PROMIS Fatigue Scale from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
The PROMIS Fatigue Scale assess a range of self-reported symptoms, from mild feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion. Fatigue is measured by frequency, duration, and intensity as well as the impact of fatigue on physical, mental, and social activities.51 The fatigue short form-8 is universal rather than disease-specific and assess fatigue over the past seven days. Each question usually has five response options ranging in value from one to five. With 1= not at all, to 5=very much).
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in Memorial Symptom Assessment Scale for Heart Failure from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
MSAS-HF is a measure of HF symptoms, that will be used (specific aim 3). MSAS-HF is a measure of 32 heart failure symptoms (27 physical and 5 psychological), which rates each symptom on the basis of presence or absence, and if present, the frequency, severity and level of distress the symptom causes over the past 7 days.46 There is an average score for each symptom, and subscales in HF, physical, and psychological symptoms.46
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in Self-Efficacy for Exercise Scale from baseline to post, baseline to 6 months, and post to 6 months
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Self-Efficacy for Exercise Scale is used to evaluate how strongly patients feel they can exercise in the face of common barriers. There are 9 items with 10 choices ranging from 0 meaning no confidence to 10 meaning very confident they could/would exercise despite the barrier. Reliability was demonstrated with a alpha coefficient of 0.93 and validity, by factor loadings of all 9 items greater than 0.50 and path coefficients greater than 0.70.56,57 This scale has been validated in a group healthy minority older adults and in a group of older adults ~85+ living in a retirement community (Caucasian, female and unmarried).56,57
Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Change in Outcome Expectations for Exercise Scale-2, from baseline to post, baseline to 6 months, and post to 6 months.
Time Frame: Baseline, 6-8 weeks after baseline and 5-6 months after baseline
Outcome Expectations for Exercise Scale-2 is used to measure positive and negative expectations for engaging in exercise. There are 13 items with 5 choices on a scale range from 1 strongly agree, 2 agree, 3 neither agree or disagree, 4 disagree, 5 strongly disagree. There are 2 subscales, one for the positive (9 items) or benefits expected by engaging in exercise and the other on possible negative (4 items) outcomes from exercise. The each sub scale is then summed and divided by the number of items giving you an average score for positive and negative expectations score.58
Baseline, 6-8 weeks after baseline and 5-6 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Christine Haedtke, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2018

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1801643369
  • 5K12HL133310-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Identifiable data will be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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