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Completed

NCT Number: NCT03119844

Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Motor Activity Physical Activity

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Other

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

Other

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.

Primary outcomes

  1. Six-minute walk test to measure functional capacity change

    Time frame: Pre and post 4 weeks of rehabilitation programs

    According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs

  2. Inflammatory markers

    Time frame: Pre and post 4 weeks of rehabilitation programs

    Evaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-α)

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: Pre and post 4 weeks of rehabilitation programs

    By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure

  2. Peripheral muscle strength

    Time frame: Pre and post 4 weeks of rehabilitation programs

    By dynamometry, assessing the change in the peak force of quadriceps femoris muscle

  3. Quality of life

    Time frame: Pre and post 4 weeks of rehabilitation programs

    By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life

Other outcomes

  1. Six-minute walk test to measure functional capacity change

    Time frame: Follow up after 3 months of the end of the rehabilitation programs

    Evaluate the improvement in functional capacity

  2. Respiratory muscle strength

    Time frame: Follow up after 3 months of the end of the rehabilitation programs

    By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure

  3. Peripheral muscle strength

    Time frame: Follow up after 3 months of the end of the rehabilitation programs

    By dynamometry, assessing the change in the peak force of quadriceps

  4. Quality of life

    Time frame: Follow up after 3 months of the end of the rehabilitation programs

    By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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