Rehabilitation With Exercises in Cardiovascular Diseases

NCT03771573 | Completed

• 1 other identifier: 2.728.401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Cardiovascular diseases are the main causes of death in Brazil and in the world, associated with a large number of people with physical disabilities and disability, significantly burdening public health expenditures. Some patients end up having the need to do cardiac surgeries. , and consequently suffer complications associated with the surgical process due to prolonged rest in the bed, and complications are directly related to the morbidity and mortality rate in these patients. Thus, cardiac rehabilitation has great scientific evidences that directly impacts functional capacity, quality of life and thus reducing the morbimortality rate of these patients. However, it is worth noting that there is no outpatient cardiovascular rehabilitation service linked to the single health system (SUS) in the Amazon Region, that is, involving phase III of cardiac rehabilitation with defined and structured protocols for the group of patients already mentioned. OBJECTIVE: To analyze the clinical evolution of patients in the postoperative period of coronary artery bypass grafting and / or valve replacement (phase III), in outpatient treatment. METHODOLOGY: It is a a longitudinal study, with quantitative variables to be performed in a single center within a year (12 months). Which will evaluate the effects of phase III cardiac rehabilitation of patients undergoing cardiac surgery through an evaluation, which will evaluate heart rate variability, functional capacity by six-minute walk test, pulmonary volumes and capacities by spirometry, percutaneous strength and ventilatory muscle, MRC scale and manovacuometry, respectively, and the application of a quality of life assessment questionnaire. Subsequently, the protocol of 20 sessions will be applied and at the end the same variables will be re-evaluated. EXPECTED RESULTS: It is expected from the application of this research that the protocol suggested for the phase III cardiac rehabilitation of patients submitted to cardiac surgery will bring benefits to patients, such as improvement in heart rate variability, improvement in functional capacity, improvement in quality of life, and reduction in morbidity and mortality rates.

Conditions

Cardiovascular Diseases

Keywords

REHABILITATION; PHYSICAL THERAPY; CARDIOVASCULAR DISEASE

Outcome Measures

Primary Outcomes (2)

• Heart rate variability

  For the collection, the patients will be placed in the supine position and kept at rest for 10 minutes to stabilize the vital signs, after which HR and RR intervals (iR-R) will be recorded, with a duration of 10 minutes. Patient oriented not to perform movements and not to talk during the collection period. The recording of the VFC will be performed by means of a POLAR® brand, RS800CX (Polar Electro TM, Kempele, Finland), where the HR signal will be picked up by a strap with the signal receiver placed in the patient's chest at the time of the xiphoid process of the sternum. The data recorded by the frequency meter will be transferred to the Polar ProTrainer® Software via an infrared signal emitting interface, where it will be stored and subsequently exported in .txt format. The data obtained will be compared before and after the completion of the cardiovascular rehabilitation protocol in the control and intervention groups, among the same.

  during 3 months

• Respiratoey muscle strenght

  Respiratory muscle strength is evaluated with a digital manovacuometer. The patient in the seated position and using a nasal clip performs up to eight maximal inspiration and expiration maneuvers. Measurement of MIP occurs as follows: a nasal clip is used to prevent air from escaping through the nostrils and patients are instructed to place the connection mouthpiece to the manometer, then it is required to empty the lungs. The highest recorded value is the one used for the analysis. In order to measure PEmáx, the patient is asked to fill the air lungs as far as possible to the CPT, making a forced inspiration, and then, with the nasal clip and the manovacuometer connection nozzle correctly positioned, to perform an expiration up to the VR level, held for one second. This maneuver is also performed three times and its values were recorded by the equipment.

  during 3 months

Study Arms (3)

Home based intervention

EXPERIMENTAL

will be submitted to a total of 24 sessions of an unsupervised Cardiovascular Physical Therapy protocol, composed of the following steps: warm up, proper training (aerobic training + muscle training for upper and lower limbs with theraband in 5 series with 10 repetitions) often three times a week for eight weeks.

Other: Physical exercise

Control group

PLACEBO COMPARATOR

Will not be submitted to the Cardiovascular Physiotherapy Rehabilitation protocol for unsupervised domiciliary, only monitorization of cardiovascular variables.

Other: monitoring

Professional seupervision based

ACTIVE COMPARATOR

eight weeks of supervised activities by professional. Each day and for 20 days (20 sessions), volunteers will undergo exercises on cycle ergometer during 30 minutes for upper and lower limbs

Other: Physical exercise

Interventions

Physical exercise OTHER

Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy

Home based intervention; Professional seupervision based

monitoring OTHER

the patients will be under monitoring to investigate the evolution of the disease

Control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cardiac surgery;
• Both sexes and age group between 40 and 70 years;
• Who were discharged from ambulatory;
• That they agree to participate in the survey

You may not qualify if:

• Patients with Osteomioarticular diseases in upper and lower limbs and neurological diseases that may interfere with the performance of the exercises proposed in the protocol.
• Female patients in the climacteric.
• Patients with cardiovascular diseases such as uncontrolled arterial hypertension, arrhythmias that use cardiac pacemakers, infectious diseases that affect the cardiovascular system such as Chagas disease, Heart Failure and / or patients with diabetes mellitus.
• With simultaneous lung diseases, such as asthma, COPD, collagen diseases (eg, scleroderma) and sarcoidosis.
• Occupational diseases, such as pneumoconiosis, hypersensitivity pneumonia.

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Universidade do Estado do Pará: collaborator

Study Sites (1)

Universidade da Amazônia

Belém, Pará, 66060902, Brazil

Location

Related Publications (5)

• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

  PMID: 26764059 RESULT

• Borges JP, Mediano MF, Farinatti P, Coelho MP, Nascimento PM, Lopes GO, Kopiler DA, Tibirica E. The Effects of Unsupervised Home-based Exercise Upon Functional Capacity After 6 Months of Discharge From Cardiac Rehabilitation: A Retrospective Observational Study. J Phys Act Health. 2016 Nov;13(11):1230-1235. doi: 10.1123/jpah.2016-0058. Epub 2016 Aug 24.

  PMID: 27333938 RESULT

• Lavie CJ, Arena R, Swift DL, Johannsen NM, Sui X, Lee DC, Earnest CP, Church TS, O'Keefe JH, Milani RV, Blair SN. Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. Circ Res. 2015 Jul 3;117(2):207-19. doi: 10.1161/CIRCRESAHA.117.305205.

  PMID: 26139859 RESULT

• Caruso FC, Simoes RP, Reis MS, Guizilini S, Alves VL, Papa V, Arena R, Borghi-Silva A. High-Intensity Inspiratory Protocol Increases Heart Rate Variability in Myocardial Revascularization Patients. Braz J Cardiovasc Surg. 2016 Feb;31(1):38-44. doi: 10.5935/1678-9741.20160007.

  PMID: 27074273 RESULT

• Hamm LF, Wenger NK, Arena R, Forman DE, Lavie CJ, Miller TD, Thomas RJ. Cardiac rehabilitation and cardiovascular disability: role in assessment and improving functional capacity: a position statement from the American Association of Cardiovascular and Pulmonary Rehabilitation. J Cardiopulm Rehabil Prev. 2013 Jan-Feb;33(1):1-11. doi: 10.1097/HCR.0b013e31827aad9e.

  PMID: 23254246 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rodrigo S Rocha, Phd

  Universidade do Estado do Pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: THE BLIND INVESTIGATOR, WHO WILL NOT KNOW THE GROUPS AND THE STUDY, WILL RECEIVE THE DATED NAMES WITH CODES TO CARRY OUT DATA ANALYSIS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invastigator

Model Details: BLINDED AND RANDOMIZED CLINICAL TRIAL

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 11, 2018
• Study Start: September 1, 2018
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

BR (1)