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

Primary Purpose

Heart Failure, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Placebo Phototherapy
Active Phototherapy
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Exercise and placebo phototherapy

    Exercise and active phototherapy

    Arm Description

    Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol

    Active phototherapy and Cycle ergometer exercise rehabilitation protocol

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Respiratory muscle strength
    By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
    Peripheral muscle strength
    By dynamometry, assessing the change in the peak force of quadriceps femoris muscle
    Quality of life
    By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life

    Full Information

    First Posted
    April 11, 2017
    Last Updated
    August 8, 2017
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03119844
    Brief Title
    Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure
    Official Title
    Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Physical Activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise and placebo phototherapy
    Arm Type
    Experimental
    Arm Description
    Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol
    Arm Title
    Exercise and active phototherapy
    Arm Type
    Experimental
    Arm Description
    Active phototherapy and Cycle ergometer exercise rehabilitation protocol
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo Phototherapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Active Phototherapy
    Intervention Description
    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 Outcome Measure Information:
    Title
    Six-minute walk test to measure functional capacity change
    Description
    According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
    Time Frame
    Pre and post 4 weeks of rehabilitation programs
    Title
    Inflammatory markers
    Description
    Evaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-α)
    Time Frame
    Pre and post 4 weeks of rehabilitation programs
    Secondary Outcome Measure Information:
    Title
    Respiratory muscle strength
    Description
    By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
    Time Frame
    Pre and post 4 weeks of rehabilitation programs
    Title
    Peripheral muscle strength
    Description
    By dynamometry, assessing the change in the peak force of quadriceps femoris muscle
    Time Frame
    Pre and post 4 weeks of rehabilitation programs
    Title
    Quality of life
    Description
    By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life
    Time Frame
    Pre and post 4 weeks of rehabilitation programs
    Other Pre-specified Outcome Measures:
    Title
    Six-minute walk test to measure functional capacity change
    Description
    Evaluate the improvement in functional capacity
    Time Frame
    Follow up after 3 months of the end of the rehabilitation programs
    Title
    Respiratory muscle strength
    Description
    By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
    Time Frame
    Follow up after 3 months of the end of the rehabilitation programs
    Title
    Peripheral muscle strength
    Description
    By dynamometry, assessing the change in the peak force of quadriceps
    Time Frame
    Follow up after 3 months of the end of the rehabilitation programs
    Title
    Quality of life
    Description
    By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life
    Time Frame
    Follow up after 3 months of the end of the rehabilitation programs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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