Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03119844
Enrollment
40
Registered
2017-04-19
Start date
2016-05-31
Completion date
2017-06-30
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Physical Activity

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.

Interventions

OTHERExercise

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.

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.

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.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Six-minute walk test to measure functional capacity changePre and post 4 weeks of rehabilitation programsAccording to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
Inflammatory markersPre and post 4 weeks of rehabilitation programsEvaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-α)

Secondary

MeasureTime frameDescription
Respiratory muscle strengthPre and post 4 weeks of rehabilitation programsBy manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
Peripheral muscle strengthPre and post 4 weeks of rehabilitation programsBy dynamometry, assessing the change in the peak force of quadriceps femoris muscle
Quality of lifePre and post 4 weeks of rehabilitation programsBy Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life

Other

MeasureTime frameDescription
Peripheral muscle strengthFollow up after 3 months of the end of the rehabilitation programsBy dynamometry, assessing the change in the peak force of quadriceps
Respiratory muscle strengthFollow up after 3 months of the end of the rehabilitation programsBy manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
Quality of lifeFollow up after 3 months of the end of the rehabilitation programsBy Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life
Six-minute walk test to measure functional capacity changeFollow up after 3 months of the end of the rehabilitation programsEvaluate the improvement in functional capacity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026