Other Functional Disturbances Following Cardiac SurgeryPBCPTNCT02437240

Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

A study testing Pilates-based CPT and Traditional CPT in people with Other Functional Disturbances Following Cardiac Surgery, run by National Yang Ming Chiao Tung University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Other Functional Disturbances Following Cardiac Surgery
What is being tested?: Pilates-based CPT and Traditional CPT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: No sites listed yet
Study dates: Aug 2014to Jul 2017
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

post open heart surgery
FVC> 80% of predicted and/or FEV1>70% of predicted
age >/=20 years old
approve inform consent

Who cannot join

preoperative severe pulmonary hypertension
moderate to severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease
heart failure or s/p heart transplant
emergent surgery

About this study

Official title: Effects of Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.

Read the detailed description

Postoperative pulmonary and musculoskeletal complications are the most frequent and significant contributor to morbidity, mortality with hospitalization. Pilates-based exercise has be applied to improve core control, movement efficiency and postural stability. High incidence of musculoskeletal problems have been concerned in relation to the patient's functional recovery after cardiac surgery. However, no literature is addressed how to manage this issue effectively till now. The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy for in-patients after cardiac surgery. This is a single-blinded, randomized control trial. Investigators will enroll pre-cardiac surgery and allocate subjects to modified Pilates-based training group or control group using block randomization.The training protocol will be based on pilates concepts. The control group is treated with a conventional protocol of physical therapy. The study will be carried on whole in-patient phase. During this period, patients received respiratory motion analysis, chest wall muscles mobility, lung function and endurance evaluation. Patients' changes in respiratory movement, cardiopulmonary endurance, and lung function will be evaluated by an assessor blinded to the intervention at admission and discharge from hospital. After 6 months after hospital discharge, patient's respiratory motion, lung function and disease specific health related quality of life will be evaluated. All outcomes will be described by mean (SD) or number (%). Independent t test or chi square test will be used to compare the basic data difference between training group and conventional group. Then, two-way analysis of variance or two-way analysis of covariance will be used to compare the outcomes difference between groups. Alpha level is set at 0.05.

Conditions: Other Functional Disturbances Following Cardiac Surgery
Being tested: Pilates-based CPT, Traditional CPT
Keywords: Pilates-based exercise, respiratory mechanics, cardiopulmonary physical therapy, sternotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pilates-based CPTBehavioural
To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery
Traditional CPTBehavioural
A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on

Study groups in NCT02437240
Study group	Role	What they receive
Pilates-based CPT	Experimental	incorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery Receives: Behavioral: Pilates-based CPT
Traditional CPT	Active comparator	usual bed side cardiopulmonary physical therapy after cardiac surgery Receives: Behavioral: Traditional CPT

What is being measured

The primary outcome is the main question the study is designed to answer.

change from pre-operation in respiratory mechanics
Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.
Measured: at hospital discharge, an expected average of 2 weeks after surgery

Secondary outcomes (9)

change from pre-operation in respiratory mechanics
Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at 6 month after surgery.
Measured: at 6 month after surgery
change from pre-operation in chest mobility
Chest mobility will be assessed by tape measuring the difference of chest circumference between deep inspiration and expiration. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.
Measured: at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
Abnormal breathing pattern will be assessed by physical examination and camera recording if there is any paradoxical, asymmetrical chest movements during breathing. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.
Measured: at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
Abnormal breathing pattern will be assessed by physical examination and camera recording if there is any paradoxical, asymmetrical chest movements during breathing. Participants will be followed at 6 month after surgery.
Measured: at 6 month after surgery
Percentage change from preoperative pulmonary function
Percentage of preoperative pulmonary function, including forced vital capacity (FVC), the first second forced expiratory volume (FEV1), peak inspiratory flow and peak expiratory flow are measured by spirometry at hospital discharge, an expected average of 2 weeks after cardiac surgery
Measured: at hospital discharge, an expected average of 2 weeks after surgery
Percentage change from preoperative pulmonary function
Percentage of preoperative pulmonary function, including forced vital capacity (FVC), the first second forced expiratory volume (FEV1), peak inspiratory flow and peak expiratory flow are measured by spirometry at 6 month after surgery
Measured: at 6 month after surgery
change of cardiopulmonary fitness
Six-minute walking test is used to assess cardiopulmonary fitness at hospital discharge, an expected average of 2 weeks after cardiac surgery.
Measured: at hospital discharge, an expected average of 2 weeks after cardiac surgery
cardiopulmonary exercise function
Symptom-limited graded exercise testing is used to assess cardiopulmonary exercise function at one month after hospital discharge.
Measured: at one month after hospital discharge
health related quality of life
Cardiovascular Limitations and Symptoms Profile (37 items) is used to assess disease specific health related quality of life at 6 month after hospital discharge.
Measured: at 6 month after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jul 2017

First posted7 May 2015 (estimated)
Study startAug 2014
Primary completionFeb 2017 (estimated)
Study completionJul 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Other Functional Disturbances Following Cardiac SurgeryStudies of the same condition, open and under way.
More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02437240
Sponsor's protocol ID: NationalYangMingU
Acronym: PBCPT
Status last verified: Apr 2015
First submitted: 16 Apr 2015
Last updated: 7 May 2015
Results posted: No
Data monitoring committee: No

Publications

Grover FL, Cleveland JC Jr, Shroyer LW. Quality improvement in cardiac care. Arch Surg. 2002 Jan;137(1):28-36. doi: 10.1001/archsurg.137.1.28.
PubMed 11772211
Lunardi AC, Marques da Silva CC, Rodrigues Mendes FA, Marques AP, Stelmach R, Fernandes Carvalho CR. Musculoskeletal dysfunction and pain in adults with asthma. J Asthma. 2011 Feb;48(1):105-10. doi: 10.3109/02770903.2010.520229. Epub 2010 Dec 29.
PubMed 21189115
Kantor E, Poupard L, Le Bozec S, Bouisset S. Does body stability depend on postural chain mobility or stability area? Neurosci Lett. 2001 Aug 3;308(2):128-32. doi: 10.1016/s0304-3940(01)01986-3.
PubMed 11457576
Perri M. Pain and Faulty Breathing: A Pilot Study. J Bodywork & Mov Ther. 2004 (8): 297-306.
Sasseron AB, Figueiredo LC, Trova K, Cardoso AL, Lima NM, Olmos SC, Petrucci O. Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):490-6. doi: 10.1590/s0102-76382009000500010. English, Portuguese.
PubMed 20305922
Wynne R, Botti M. Postoperative pulmonary dysfunction in adults after cardiac surgery with cardiopulmonary bypass: clinical significance and implications for practice. Am J Crit Care. 2004 Sep;13(5):384-93.
PubMed 15470854
Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.
PubMed 15955148
Gosselink R, Schrever K, Cops P, Witvrouwen H, De Leyn P, Troosters T, Lerut A, Deneffe G, Decramer M. Incentive spirometry does not enhance recovery after thoracic surgery. Crit Care Med. 2000 Mar;28(3):679-83. doi: 10.1097/00003246-200003000-00013.
PubMed 10752814
Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major surgeries: a systematic review. Rev Bras Fisioter. 2011 Sep-Oct;15(5):343-50. doi: 10.1590/s1413-35552011005000025. Epub 2011 Oct 14.
PubMed 22002191
Pilates JH 1988 Your Health. Revised edition. Robbins J (ed). Presentation Dynamics, Incline Village, NV. First published, 1934
Rogers K, Gibson AL. Eight-week traditional mat Pilates training-program effects on adult fitness characteristics. Res Q Exerc Sport. 2009 Sep;80(3):569-74. doi: 10.1080/02701367.2009.10599595.
PubMed 19791643
Segal NA, Hein J, Basford JR. The effects of Pilates training on flexibility and body composition: an observational study. Arch Phys Med Rehabil. 2004 Dec;85(12):1977-81. doi: 10.1016/j.apmr.2004.01.036.
PubMed 15605336
Sorosky S, Stilp S, Akuthota V. Yoga and pilates in the management of low back pain. Curr Rev Musculoskelet Med. 2008 Mar;1(1):39-47. doi: 10.1007/s12178-007-9004-1.
PubMed 19468897
Herrington L, DaviesR. The influence of Pilates training on the ability to contract the Transversus Abdominis muscle in asymptomatic individuals. J Bodyw Mov Ther 2005;9:52-7
Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.
PubMed 20094704

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery
ClinicalTrials.gov ID: NCT02437240
Acronym / sponsor ID: PBCPT / NationalYangMingU
Conditions: Other Functional Disturbances Following Cardiac Surgery
Keywords: Pilates-based exercise, respiratory mechanics, cardiopulmonary physical therapy, sternotomy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 140 participants (estimated)
Lead sponsor: National Yang Ming Chiao Tung UniversityUniversity, hospital or other
Collaborators: Cheng-Hsin General Hospital
Study start: Aug 2014
Primary completion: Feb 2017 (estimated)
Study completion: Jul 2017 (estimated)
First posted: 7 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 purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pilates-based CPT	Experimental	Behavioral: Pilates-based CPTincorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery
Traditional CPT	Active comparator	Behavioral: Traditional CPTusual bed side cardiopulmonary physical therapy after cardiac surgery

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

post open heart surgery
FVC> 80% of predicted and/or FEV1>70% of predicted
age >/=20 years old
approve inform consent

Key exclusion criteria (4 listed)

preoperative severe pulmonary hypertension
moderate to severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease
heart failure or s/p heart transplant
emergent surgery

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
Pilates-based CPTTo emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery	Behavioural	Pilates-based CPT
Traditional CPTA traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on	Behavioural	Traditional CPT

Primary outcome

change from pre-operation in respiratory mechanics
Time frame: at hospital discharge, an expected average of 2 weeks after surgery
Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.

9 secondary outcomes

change from pre-operation in respiratory mechanics
Time frame: at 6 month after surgery
change from pre-operation in chest mobility
Time frame: at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
Time frame: at hospital discharge, an expected average of 2 weeks after surgery
abnormal breathing pattern
Time frame: at 6 month after surgery
Percentage change from preoperative pulmonary function
Time frame: at hospital discharge, an expected average of 2 weeks after surgery
Percentage change from preoperative pulmonary function
Time frame: at 6 month after surgery
change of cardiopulmonary fitness
Time frame: at hospital discharge, an expected average of 2 weeks after cardiac surgery
cardiopulmonary exercise function
Time frame: at one month after hospital discharge
health related quality of life
Time frame: at 6 month after hospital discharge

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
Background: PubMed 11772211Grover FL, Cleveland JC Jr, Shroyer LW. Quality improvement in cardiac care. Arch Surg. 2002 Jan;137(1):28-36. doi: 10.1001/archsurg.137.1.28.
Background: PubMed 21189115Lunardi AC, Marques da Silva CC, Rodrigues Mendes FA, Marques AP, Stelmach R, Fernandes Carvalho CR. Musculoskeletal dysfunction and pain in adults with asthma. J Asthma. 2011 Feb;48(1):105-10. doi: 10.3109/02770903.2010.520229. Epub 2010 Dec 29.
Background: PubMed 11457576Kantor E, Poupard L, Le Bozec S, Bouisset S. Does body stability depend on postural chain mobility or stability area? Neurosci Lett. 2001 Aug 3;308(2):128-32. doi: 10.1016/s0304-3940(01)01986-3.
BackgroundPerri M. Pain and Faulty Breathing: A Pilot Study. J Bodywork & Mov Ther. 2004 (8): 297-306.
Background: PubMed 20305922Sasseron AB, Figueiredo LC, Trova K, Cardoso AL, Lima NM, Olmos SC, Petrucci O. Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):490-6. doi: 10.1590/s0102-76382009000500010. English, Portuguese.
Background: PubMed 15470854Wynne R, Botti M. Postoperative pulmonary dysfunction in adults after cardiac surgery with cardiopulmonary bypass: clinical significance and implications for practice. Am J Crit Care. 2004 Sep;13(5):384-93.
Background: PubMed 15955148Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.
Background: PubMed 10752814Gosselink R, Schrever K, Cops P, Witvrouwen H, De Leyn P, Troosters T, Lerut A, Deneffe G, Decramer M. Incentive spirometry does not enhance recovery after thoracic surgery. Crit Care Med. 2000 Mar;28(3):679-83. doi: 10.1097/00003246-200003000-00013.
Background: PubMed 22002191Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major surgeries: a systematic review. Rev Bras Fisioter. 2011 Sep-Oct;15(5):343-50. doi: 10.1590/s1413-35552011005000025. Epub 2011 Oct 14.
BackgroundPilates JH 1988 Your Health. Revised edition. Robbins J (ed). Presentation Dynamics, Incline Village, NV. First published, 1934
Background: PubMed 19791643Rogers K, Gibson AL. Eight-week traditional mat Pilates training-program effects on adult fitness characteristics. Res Q Exerc Sport. 2009 Sep;80(3):569-74. doi: 10.1080/02701367.2009.10599595.
Background: PubMed 15605336Segal NA, Hein J, Basford JR. The effects of Pilates training on flexibility and body composition: an observational study. Arch Phys Med Rehabil. 2004 Dec;85(12):1977-81. doi: 10.1016/j.apmr.2004.01.036.
Postoperative complications among patients undergoing cardiac surgeryLink provided by the sponsor.

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 Pilates-based CPT and Traditional CPT in people with Other Functional Disturbances Following Cardiac Surgery, run by National Yang Ming Chiao Tung University.

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 4 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: status not confirmed, as of the sponsor's last update on 7 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?

Results are not available in the source record.

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?

change from pre-operation in respiratory mechanics (time frame: at hospital discharge, an expected average of 2 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437240, which also lists 29 linked publications.

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 7 May 2015.