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

Sponsor
Instituto do Coracao (Other)
Overall Status
Completed
CT.gov ID
NCT02441452
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
40
2
25.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Early rehabilitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Functional Capacity of Exercise and Lung Function in Patients Submitted to Early Rehabilitation Program After Nuss Procedure: a Randomized Controlled Trial
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

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

    1. Time to first postoperative ambulation [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 [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 [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sâmia Geórgia Dantas Linhares, Physiotherapist, Instituto do Coracao
    ClinicalTrials.gov Identifier:
    NCT02441452
    Other Study ID Numbers:
    • InCor Heart Institute
    First Posted:
    May 12, 2015
    Last Update Posted:
    May 12, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Sâmia Geórgia Dantas Linhares, Physiotherapist, Instituto do Coracao
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2015