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

NCT ID: NCT02441452

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Funnel Chest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Early rehabilitation

Intervention Type: OTHER

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

Conventional care

Usual care routine postoperative.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early rehabilitation

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

Intervention Type: OTHER

Other Intervention Names

Physical exercises and breathing exercises after surgery

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sâmia Geórgia Dantas Linhares

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

InCor Heart Institute

Identifier Type: -

Identifier Source: org_study_id