Clinical trial NCT02441452: Functional Capacity of Exercise and Lung Function in Patients Submitted Early Rehabilitation
Official title: Functional Capacity of Exercise and Lung Function in Patients Submitted to Early Rehabilitation Program After Nuss Procedure: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Funnel Chest
Keywords: Nuss procedure
postoperative care
early ambulation
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to compare the functional capacity of exercise by six-minute walk test and lung function by spirometry, before and after Nuss procedure in subjects who have undergone the early rehabiliation program with those who were under conventional care. Researchers want to find out if early rehabilitation is a strategy to enhance recovery after Nuss procedure.

Detailed description: The replacement of some traditional approaches in surgical care has demonstrated that surgical recovery can be accelerated and convalescence decreased. These multimodal approaches focuses on enhancing recovery and reducing morbidity by reduction of surgical stress,minimal invasive surgery, optimized pain relief, early nutrition and ambulation.

In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity even in patients who are not restricted to bed.

However, few studies have focused on when start the mobilization and which effects on functional capacity of exercise and lung function during hospital stay.

In this trial the investigators will consider early rehabilitation to be safe and feasible in Nuss procedure.

Eligibility criteria: Inclusion Criteria:

* children who are scheduled to undergo a surgical procedure for the correction of pectus excavatum
* sign the informed consent form
* independent ambulation
* ability to understand and follow instructions
* ability to perform lung function test

Exclusion Criteria:

* contraindications for epidural catheter placement
* patients undergoing the open surgical repair of pectus excavatum
* refusal to do physical exercises on postoperative
* patients did not perform the six-minute walk test and lung function test on postoperative

Primary outcomes:
measure: Functional capacity of exercise ( six-minute walk test)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Lung function (spirometry)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes:
measure: Time to first postoperative ambulation
timeFrame: up 2 hour after surgery
measure: Pain intensity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: The length of hospital stay
timeFrame: expected average of 6 days
Other outcomes:
Locations:
Study officials:
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