Functional Capacity of Exercise and Lung Function in Patients Submitted Early Rehabilitation

Funnel Chest Clinical Trial

Official title:

Functional Capacity of Exercise and Lung Function in Patients Submitted to Early Rehabilitation Program After Nuss Procedure: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441452
• Other study ID #: InCor Heart Institute
• Status: Completed
• Phase: N/A
• First received: May 4, 2015
• Last updated: May 7, 2015
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Instituto do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Funnel Chest

Intervention

Other:
• Early rehabilitation
The physical exercises and breathing exercises are started as soon as after the Nuss procedure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Coracao	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity of exercise ( six-minute walk test)	Change from baseline in distance walking on hospital discharge	participants will be followed for the duration of hospital stay, an expected average of 6 days	No
Primary	Lung function (spirometry)	Change from baseline in lung function on hospital discharge	participants will be followed for the duration of hospital stay, an expected average of 6 days	No
Secondary	Time to first postoperative ambulation	Time from end of surgical procedure until first postoperative ambulation was used as an indicator for early rehabilitation.	up 2 hour after surgery	No
Secondary	Pain intensity	Auto-evaluation of pain (the numeric rating scale and visual analogue scale of pain from 0 -no pain- to 10 - maximal pain)	participants will be followed for the duration of hospital stay, an expected average of 6 days	No
Secondary	The length of hospital stay	Time to achieve standardized hospital discharge criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self care and no evidence of complications or untreated medical problems).	expected average of 6 days	No