Skip to main content
OpenTrials
Completed

NCT Number: NCT02441452

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early rehabilitation

Other

The physical exercises and breathing exercises are started as soon as after the Nuss procedure

Other names: Physical exercises and breathing exercises after surgery

Primary outcomes

  1. Functional capacity of exercise ( six-minute walk test)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

    Change from baseline in distance walking on hospital discharge

  2. Lung function (spirometry)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

    Change from baseline in lung function on hospital discharge

Secondary outcomes

  1. Time to first postoperative ambulation

    Time frame: up 2 hour after surgery

    Time from end of surgical procedure until first postoperative ambulation was used as an indicator for early rehabilitation.

  2. Pain intensity

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

    Auto-evaluation of pain (the numeric rating scale and visual analogue scale of pain from 0 -no pain- to 10 - maximal pain)

  3. The length of hospital stay

    Time frame: expected average of 6 days

    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).

Sponsors and collaborators

Lead sponsor

Instituto do Coracao

Other Gov

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.