Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03506737
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and Intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. In both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. The evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Transplant; Failure, Heart; Physical Activity	Other: Conventional exercise protocol; Other: Cycle ergometer exercise protocol	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional exercise protocol Conventional global exercise	Other: Conventional exercise protocol; Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
Experimental: Cycle ergometer exercise protocol Stationary cycle ergometer exercise	Other: Cycle ergometer exercise protocol; Stationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest.

Outcome Measures

Primary Outcome Measures

1. Six-minute walk test to measure functional capacity change [After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation).]

   According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs

2. Respiratory muscle strength [After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation)]

   By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure

Secondary Outcome Measures

1. Invasive mechanical ventilation [First day after transplantation.]

   Duration of invasive mechanical ventilation will be recorded after cardiac transplantation.

2. Duration of intensive care unit stay [In hospital discharge (after 4 weeks of transplantation).]

   Duration of stay in intensive care unit (in days) after transplantation will be recorded.

3. Hospitalization stay [In hospital discharge (after 4 weeks of transplantation).]

   Duration of stay in the hospital (in days) will be recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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 III and IV.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caroline Bublitz Barbosa	São Paulo		Brazil	04024002

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caroline Bublitz Barbosa, Principal Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT03506737
• Other Study ID Numbers: 74619617.3.0000.5505
• First Posted: Apr 24, 2018
• Last Update Posted: Apr 24, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Apr 24, 2018