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

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

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Physical Activity	Other: Exercise; Other: Placebo Phototherapy; Other: Active Phototherapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise and placebo phototherapy; Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol	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.
Experimental: Exercise and active phototherapy; Active phototherapy and Cycle ergometer exercise rehabilitation protocol	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: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Caroline Bublitz Barbosa, Principal Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT03119844
• Other Study ID Numbers: 54984116.6.0000.5505
• First Posted: April 19, 2017
• Last Update Posted: August 10, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases