AzTrials
AzTrials

Heart FailureNCT03615469

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

A study testing Transcutaneous electrical stimulation and Neuromuscular electrical stimulation in people with Heart Failure, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Transcutaneous electrical stimulation and Neuromuscular electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
6 Sep 2018to 1 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
Transcutaneous electrical stimulation, Neuromuscular electrical stimulation
Keywords
Neuromuscular Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, 6 minute walk test, DXA, Double Blinded randomized control trial, ActivPal, EMPI Continuum Device
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous electrical stimulationDevice

    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.

  • Neuromuscular electrical stimulationDevice

    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.

Study groups in NCT03615469
Study groupRoleWhat they receive
Neuromusclar electrical stimulationActive comparatorNMES 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.
Receives: Device: Neuromuscular electrical stimulation
Transcutaneous electrical stimulationSham comparatorFor 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
Receives: Device: Transcutaneous electrical stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6 Minute Walk Test

    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.

    Measured: From Baseline to 5-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2018
  2. Study start6 Sep 2018
  3. Primary completion1 Jul 2020
  4. Study completion1 Dec 2020

Why it stopped: Low recruitment numbers

Resources

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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615469
Sponsor's protocol ID
1801643369
Other IDs
5K12HL133310-02
Status last verified
May 2023
First submitted
20 Jul 2018
Last updated
31 May 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No Identifiable data will be made available to other researchers.

Publications

  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.

    PubMed 26811276

  • Churilla JR, Richardson MR, Pinkstaff SO, Fletcher BJ, Fletcher GF. Associations between heart failure and physical function in US adults. QJM. 2016 Oct;109(10):669-674. doi: 10.1093/qjmed/hcw042. Epub 2016 Mar 29.

    PubMed 27026699

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

    PubMed 27207191

  • Cooper LB, Mentz RJ, Sun JL, Schulte PJ, Fleg JL, Cooper LS, Pina IL, Leifer ES, Kraus WE, Whellan DJ, Keteyian SJ, O'Connor CM. Psychosocial Factors, Exercise Adherence, and Outcomes in Heart Failure Patients: Insights From Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Circ Heart Fail. 2015 Nov;8(6):1044-51. doi: 10.1161/CIRCHEARTFAILURE.115.002327.

    PubMed 26578668

  • O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

    PubMed 19351941

  • Tierney S, Mamas M, Skelton D, Woods S, Rutter MK, Gibson M, Neyses L, Deaton C. What can we learn from patients with heart failure about exercise adherence? A systematic review of qualitative papers. Health Psychol. 2011 Jul;30(4):401-10. doi: 10.1037/a0022848.

    PubMed 21534681

  • Hambrecht R, Fiehn E, Weigl C, Gielen S, Hamann C, Kaiser R, Yu J, Adams V, Niebauer J, Schuler G. Regular physical exercise corrects endothelial dysfunction and improves exercise capacity in patients with chronic heart failure. Circulation. 1998 Dec 15;98(24):2709-15. doi: 10.1161/01.cir.98.24.2709.

    PubMed 9851957

  • Banerjee P, Caulfield B, Crowe L, Clark AL. Prolonged electrical muscle stimulation exercise improves strength, peak VO2, and exercise capacity in patients with stable chronic heart failure. J Card Fail. 2009 May;15(4):319-26. doi: 10.1016/j.cardfail.2008.11.005. Epub 2009 Jan 29.

    PubMed 19398080

  • Maillefert JF, Eicher JC, Walker P, Dulieu V, Rouhier-Marcer I, Branly F, Cohen M, Brunotte F, Wolf JE, Casillas JM, Didier JP. Effects of low-frequency electrical stimulation of quadriceps and calf muscles in patients with chronic heart failure. J Cardiopulm Rehabil. 1998 Jul-Aug;18(4):277-82. doi: 10.1097/00008483-199807000-00004.

    PubMed 9702606

  • Sillen MJH, Speksnijder CM, Eterman RA, Janssen PP, Wagers SS, Wouters EFM, Uszko-Lencer NHMK, Spruit MA. Effects of neuromuscular electrical stimulation of muscles of ambulation in patients with chronic heart failure or COPD: a systematic review of the English-language literature. Chest. 2009 Jul;136(1):44-61. doi: 10.1378/chest.08-2481. Epub 2009 Apr 10.

    PubMed 19363213

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.

    PubMed 28122885

  • Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.

    PubMed 23616602

  • Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available.

    PubMed 23283859

  • Reeves GR, Whellan DJ, Patel MJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva AM, Kitzman DW. Comparison of Frequency of Frailty and Severely Impaired Physical Function in Patients >/=60 Years Hospitalized With Acute Decompensated Heart Failure Versus Chronic Stable Heart Failure With Reduced and Preserved Left Ventricular Ejection Fraction. Am J Cardiol. 2016 Jun 15;117(12):1953-8. doi: 10.1016/j.amjcard.2016.03.046. Epub 2016 Apr 6.

    PubMed 27156830

  • Lavie CJ, Arena R, Swift DL, Johannsen NM, Sui X, Lee DC, Earnest CP, Church TS, O'Keefe JH, Milani RV, Blair SN. Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. Circ Res. 2015 Jul 3;117(2):207-19. doi: 10.1161/CIRCRESAHA.117.305205.

    PubMed 26139859

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous electrical stimulation and Neuromuscular electrical stimulation in people with Heart Failure, run by Indiana University 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 31 May 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in 6 Minute Walk Test (time frame: From Baseline to 5-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615469, which also lists 75 linked publications.

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 31 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in