Heart FailureNCT03119844
Effects of Phototherapy Associated to Exercise-based Rehabilitation Program in Heart Failure
A study testing Exercise and Active Phototherapy in people with Heart Failure and Physical Activity, run by Federal University of São Paulo.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Heart Failure, Physical Activity
- What is being tested?
- Exercise and Active Phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- chronic lung disease confirmed by pulmonary function testing
- unstable angina pectoris and acute coronary syndromes
- dialysis
- neuromuscular and psychiatric conditions that interfere in exercise
About this study
Official title: Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
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
- Being tested
- Exercise, Placebo Phototherapy, Active Phototherapy
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
Placebo PhototherapyOther
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.
Active PhototherapyOther
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 group | Role | What they receive |
|---|---|---|
| Exercise and placebo phototherapy | Experimental | Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol Receives: Other: Exercise; Other: Placebo Phototherapy |
| Exercise and active phototherapy | Experimental | Active phototherapy and Cycle ergometer exercise rehabilitation protocol Receives: Other: Exercise; Other: Active Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Pre and post 4 weeks of rehabilitation programs
Secondary outcomes (3)
Respiratory muscle strength
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
Measured: Pre and post 4 weeks of rehabilitation programs
Peripheral muscle strength
By dynamometry, assessing the change in the peak force of quadriceps femoris muscle
Measured: Pre and post 4 weeks of rehabilitation programs
Quality of life
By Minnesota Living with Heart Failure Questionnaire assessing the change in quality of life
Measured: Pre and post 4 weeks of rehabilitation programs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startMay 2016
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Bublitz Barbosa, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119844
- Sponsor's protocol ID
- 54984116.6.0000.5505
- Status last verified
- Aug 2017
- First submitted
- 11 Apr 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
- ClinicalTrials.gov ID
- NCT03119844
- Acronym / sponsor ID
- 54984116.6.0000.5505
- Conditions
- Heart Failure, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and placebo phototherapy | Experimental | Other: Exercise, Other: Placebo PhototherapyPlacebo phototherapy and Cycle ergometer exercise rehabilitation protocol |
| Exercise and active phototherapy | Experimental | Other: Exercise, Other: Active PhototherapyActive phototherapy and Cycle ergometer exercise rehabilitation protocol |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- chronic lung disease confirmed by pulmonary function testing
- unstable angina pectoris and acute coronary syndromes
- dialysis
- neuromuscular and psychiatric conditions that interfere in exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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 | Exercise and active phototherapy, Exercise and placebo phototherapy |
| Placebo PhototherapyPatients 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 | Exercise and placebo phototherapy |
| Active PhototherapyPatients 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. | Other | Exercise and active phototherapy |
Primary outcome
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)
3 secondary outcomes
Respiratory muscle strength
Time frame: Pre and post 4 weeks of rehabilitation programs
Peripheral muscle strength
Time frame: Pre and post 4 weeks of rehabilitation programs
Quality of life
Time frame: Pre and post 4 weeks of rehabilitation programs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Active Phototherapy in people with Heart Failure and Physical Activity, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test to measure functional capacity change (time frame: Pre and post 4 weeks of rehabilitation programs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.