Funnel ChestNCT02441452
Functional Capacity of Exercise and Lung Function in Patients Submitted Early Rehabilitation
A study testing Early rehabilitation in people with Funnel Chest, run by Instituto do Coracao.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Funnel Chest
- What is being tested?
- Early rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Early rehabilitation
- Keywords
- Nuss procedure, postoperative care, early ambulation
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early rehabilitationOther
Also called Physical exercises and breathing exercises after surgery
The physical exercises and breathing exercises are started as soon as after the Nuss procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early rehabilitation |
| Conventional care | No intervention | Usual care routine postoperative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity of exercise ( six-minute walk test)
Change from baseline in distance walking on hospital discharge
Measured: 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
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes (3)
Time to first postoperative ambulation
Time from end of surgical procedure until first postoperative ambulation was used as an indicator for early rehabilitation.
Measured: 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)
Measured: 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).
Measured: expected average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Funnel ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Sâmia Geórgia Dantas Linhares, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441452
- Sponsor's protocol ID
- InCor Heart Institute
- Status last verified
- May 2015
- First submitted
- 4 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Capacity of Exercise and Lung Function in Patients Submitted to Early Rehabilitation Program After Nuss Procedure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02441452
- Acronym / sponsor ID
- InCor Heart Institute
- Conditions
- Funnel Chest
- Keywords
- Nuss procedure, postoperative care, early ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto do CoracaoOther government
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early rehabilitation | Active comparator | Other: Early rehabilitationone 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 intervention | –Usual care routine postoperative. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early rehabilitationAlso: Physical exercises and breathing exercises after surgeryThe physical exercises and breathing exercises are started as soon as after the Nuss procedure | Other | Early rehabilitation |
Primary outcome
Functional capacity of exercise ( six-minute walk test)
Time frame: 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
Lung function (spirometry)
Time frame: 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
3 secondary outcomes
Time to first postoperative ambulation
Time frame: up 2 hour after surgery
Pain intensity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
The length of hospital stay
Time frame: expected average of 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early rehabilitation in people with Funnel Chest, run by Instituto do Coracao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity of exercise ( six-minute walk test) (time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.