Functional Capacity of Exercise and Lung Function in Patients Submitted Early Rehabilitation
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Typical duration for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedMay 12, 2015
May 1, 2015
2.2 years
May 4, 2015
May 7, 2015
Conditions
Keywords
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 COMPARATORone 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.
Conventional care
NO INTERVENTIONUsual care routine postoperative.
Interventions
The physical exercises and breathing exercises are started as soon as after the Nuss procedure
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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