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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03119844
Other study ID # 54984116.6.0000.5505
Secondary ID
Status Completed
Phase N/A
First received April 11, 2017
Last updated August 8, 2017
Start date May 2016
Est. completion date June 2017

Study information

Verified date August 2017
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Heart failure affects not only the cardiovascular system with structural abnormalities of the heart, but also the musculoskeletal system, leading to exercise intolerance. Objective: To evaluate the effects of a short-term exercise protocol and phototherapy, on the functional capacity and inflammatory markers in patients with heart failure. In addition, the investigators will investigate pulmonary function, peripheral and respiratory muscle strength and quality of life. Methods: Heart failure patients (left ventricular ejection fraction < 40%) will be selected from the outpatient clinic of the myocardium of the Department of Cardiology of Unifesp and randomized among two groups: patients who will be submitted to placebo phototherapy and cycle ergometer exercise; and patients who will be submitted to active phototherapy and cycle ergometer exercise. All groups will receive treatment twice a week for four weeks. Patients will be instructed to conduct home-based walking program at least twice a week. Patients will be evaluated before and after protocols regarding the pulmonary function, peripheral and respiratory muscle strength, functionality, quality of life and evaluation of systemic inflammatory mediators.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) < 40%

- New York Heart Association (NYHA) classes II and III.

Exclusion Criteria:

- chronic lung disease confirmed by pulmonary function testing

- unstable angina pectoris and acute coronary syndromes

- dialysis

- neuromuscular and psychiatric conditions that interfere in exercise

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
The exercise will be performed in a cycle ergometer, intermittently, during 40 minutes, in a moderate intensity and prescribed by the perceived exertion Borg (PEB) scale.
Placebo Phototherapy
Patients will receive the placebo application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.
Active Phototherapy
Patients will receive the active application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Outcome

Type Measure Description Time frame Safety issue
Other Six-minute walk test to measure functional capacity change Evaluate the improvement in functional capacity Follow up after 3 months of the end of the rehabilitation programs
Other Respiratory muscle strength By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure Follow up after 3 months of the end of the rehabilitation programs
Other Peripheral muscle strength By dynamometry, assessing the change in the peak force of quadriceps Follow up after 3 months of the end of the rehabilitation programs
Other Quality of life By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life Follow up after 3 months of the end of the rehabilitation programs
Primary Six-minute walk test to measure functional capacity change According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs Pre and post 4 weeks of rehabilitation programs
Primary Inflammatory markers Evaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-a) Pre and post 4 weeks of rehabilitation programs
Secondary Respiratory muscle strength By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure Pre and post 4 weeks of rehabilitation programs
Secondary Peripheral muscle strength By dynamometry, assessing the change in the peak force of quadriceps femoris muscle Pre and post 4 weeks of rehabilitation programs
Secondary Quality of life By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life Pre and post 4 weeks of rehabilitation programs
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