NCT02441452

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

May 4, 2015

Last Update Submit

May 7, 2015

Conditions

Keywords

Nuss procedurepostoperative careearly ambulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Time to first postoperative ambulation

    up 2 hour after surgery

  • Pain intensity

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

  • The length of hospital stay

    expected average of 6 days

Study Arms (2)

Early rehabilitation

ACTIVE COMPARATOR

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

Conventional care

NO INTERVENTION

Usual care routine postoperative.

Interventions

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

Also known as: Physical exercises and breathing exercises after surgery
Early rehabilitation

Eligibility Criteria

Age14 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Funnel Chest

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 12, 2015

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 12, 2015

Record last verified: 2015-05