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
About this trial
This is an interventional treatment trial for Heart Failure
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
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
NCT ID
NCT03119844
First Posted
April 11, 2017
Last Updated
August 8, 2017
Sponsor
Federal University of São Paulo
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
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Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure
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