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

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ClinicalTrials.gov Identifier: NCT03119844
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Caroline Bublitz Barbosa, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date August 10, 2017
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 13, 2017)
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure
Official Title  ICMJE Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Physical Activity
Intervention  ICMJE
  • 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.
  • Other: 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.
  • Other: 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.
Study Arms  ICMJE
  • Experimental: Exercise and placebo phototherapy
    Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol
    Interventions:
    • Other: Exercise
    • Other: Placebo Phototherapy
  • Experimental: Exercise and active phototherapy
    Active phototherapy and Cycle ergometer exercise rehabilitation protocol
    Interventions:
    • Other: Exercise
    • Other: Active Phototherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
30
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119844
Other Study ID Numbers  ICMJE 54984116.6.0000.5505
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Caroline Bublitz Barbosa, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of São Paulo
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP