Effects of Cardiac Rehabilitation on Postoperatory of Coronary Artery Bypass Graft.

Complication of CABG Clinical Trial

Official title:

Evaluation of the Effects of Different Physical Therapy on Cardiac Rehabilitation in Post Operatory Period of Coronary Artery Bypass Graft: Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410253
• Other study ID #: GPPG090650
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2011
• Last updated: March 21, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-Patients are recruited from the waiting list for a first CABG intervention at the Porto Alegre Clinical Hospital.

Exclusion Criteria:

• chronic renal failure,

• unstable angina,

• moderate or severe valve disease,

• complex cardiac arrhythmia,

• stroke,

• inability to exercise the lower limbs,

• subjects with forced expiratory volume in 1 second less than 70% of predicted

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Complication of CABG

Intervention

Other:
• Combination of four techniques of physiotherapy
The patients receive conventional physiotherapy, expiratory positive airway pressure, inspiratory muscle training and physical exercise. Twice daily for seven days
• Combination of three techniques of physiotherapy
Patients receive conventional physiotherapy, expiratory positive airway pressure and physical exercise. Twice daily for seven days
• Combination of two techniques of physiotherapy
Patients receive conventional physiotherapy,expiratory positive airway pressure respiratory muscle training. Twice daily for seven days
• standard therapy
Patients receive conventional physiotherapy and expiratory positive airway pressure. Twice daily for seven days

Locations

Country	Name	City	State
Brazil	Porto Alegre Clinical Hospital	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	submaximal functional capacity	functional capacity evaluated by six-minute walk test	Change from Baseline in functional capacity at seven days and thirty days after surgery	No
Secondary	capacity functional	cardiopulmonary exercise testing ( VO2)	evaluated 40 days after surgery	No
Secondary	respiratory muscle strength	Both PImax and PEmax were obtained using a pressure transducer	Change from Baseline in respiratory muscle strength at seven days and thirty days after surgery	No
Secondary	lung function	assessed by spirometry (FVC and FEV1)	Change from Baseline in lung function at seven days and thirty days after surgery	No