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

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

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.

Study Overview

• Status: Completed
• Conditions: Funnel Chest
• Intervention / Treatment: Other: Early rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early rehabilitation; one day before surgery, patients and their families were instructed by physiotherapists than explained the importance to perform physical exercises and breath exercises in postoperative. At the postoperative recovery room, after extubation and fully awake, patients started physiotherapy exercises, as physical exercises of moving up upper and lower extremities accompanied by deep breathing exercises. After than, the patients standed up beside the bed and if there was no complications, patients performed ambulation.	Other: Early rehabilitation; The physical exercises and breathing exercises are started as soon as after the Nuss procedure; Other Names: Physical exercises and breathing exercises after surgery
No Intervention: Conventional care; Usual care routine postoperative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Instituto do Coracao
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: postoperative care; Nuss procedure; early ambulation
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: InCor Heart Institute