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

NCT03119844 | Completed DMC

• 1 other identifier: 54984116.6.0000.5505
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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

  Pre and post 4 weeks of rehabilitation programs

• Inflammatory markers

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

  Pre and post 4 weeks of rehabilitation programs

Secondary Outcomes (3)

• Respiratory muscle strength

  Pre and post 4 weeks of rehabilitation programs

• Peripheral muscle strength

  Pre and post 4 weeks of rehabilitation programs

• Quality of life

  Pre and post 4 weeks of rehabilitation programs

Other Outcomes (4)

• Six-minute walk test to measure functional capacity change

  Follow up after 3 months of the end of the rehabilitation programs

• Respiratory muscle strength

  Follow up after 3 months of the end of the rehabilitation programs

• Peripheral muscle strength

  Follow up after 3 months of the end of the rehabilitation programs

Study Arms (2)

Exercise and placebo phototherapy

EXPERIMENTAL

Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol

Other: Exercise; Other: Placebo Phototherapy

Exercise and active phototherapy

EXPERIMENTAL

Active phototherapy and Cycle ergometer exercise rehabilitation protocol

Other: Exercise; Other: Active Phototherapy

Interventions

Exercise OTHER

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.

Exercise and active phototherapy; Exercise and placebo phototherapy

Placebo Phototherapy OTHER

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.

Exercise and placebo phototherapy

Active Phototherapy OTHER

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.

Exercise and active phototherapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• chronic lung disease confirmed by pulmonary function testing
• unstable angina pectoris and acute coronary syndromes
• dialysis
• neuromuscular and psychiatric conditions that interfere in exercise

Sponsors & Collaborators

• Federal University of São Paulo: lead

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share