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

Heart Failure Clinical Trial

Official title:

Building Strength Through Rehabilitation for Heart Failure Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03615469
• Other study ID #: 1801643369
• Secondary ID: 5K12HL133310-02
• Status: Terminated
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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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. — View Citation

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* Note: There are 75 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline to 5-6 months