NCT02437240

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

April 16, 2015

Last Update Submit

May 4, 2015

Conditions

Other Functional Disturbances Following Cardiac Surgery

Keywords

Pilates-based exerciserespiratory mechanicscardiopulmonary physical therapysternotomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    at hospital discharge, an expected average of 2 weeks after surgery

Secondary Outcomes (9)

  • change from pre-operation in respiratory mechanics

    at 6 month after surgery

  • change from pre-operation in chest mobility

    at hospital discharge, an expected average of 2 weeks after surgery

  • abnormal breathing pattern

    at hospital discharge, an expected average of 2 weeks after surgery

  • abnormal breathing pattern

    at 6 month after surgery

  • Percentage change from preoperative pulmonary function

    at hospital discharge, an expected average of 2 weeks after surgery

  • +4 more secondary outcomes

Study Arms (2)

Pilates-based CPT

EXPERIMENTAL

incorporated the concept of pilates training into cardiopulmonary physical therapy after cardiac surgery

Behavioral: Pilates-based CPT

Traditional CPT

ACTIVE COMPARATOR

usual bed side cardiopulmonary physical therapy after cardiac surgery

Behavioral: Traditional CPT

Interventions

Pilates-based CPTBEHAVIORAL

To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery

Pilates-based CPT
Traditional CPTBEHAVIORAL

A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on

Traditional CPT

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (29)

  • 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.

    PMID: 11772211BACKGROUND

  • 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.

    PMID: 21189115BACKGROUND

  • 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.

    PMID: 11457576BACKGROUND

  • Perri M. Pain and Faulty Breathing: A Pilot Study. J Bodywork & Mov Ther. 2004 (8): 297-306.

    BACKGROUND

  • 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.

    PMID: 20305922BACKGROUND

  • 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.

    PMID: 15470854BACKGROUND

  • 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.

    PMID: 15955148BACKGROUND

  • 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.

    PMID: 10752814BACKGROUND

  • 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.

    PMID: 22002191BACKGROUND

  • Pilates JH 1988 Your Health. Revised edition. Robbins J (ed). Presentation Dynamics, Incline Village, NV. First published, 1934

    BACKGROUND

  • 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.

    PMID: 19791643BACKGROUND

  • 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.

    PMID: 15605336BACKGROUND

  • 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.

    PMID: 19468897BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 20094704BACKGROUND

  • Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.

    PMID: 22030232BACKGROUND

  • Johnson EG, Larsen A, Ozawa H, Wilson CA, Kennedy KL. The effects of Pilates-based exercise on dynamic balance in healthy adults. J Bodyw Mov Ther 2007;11:238-42

    BACKGROUND

  • Irez GB, Ozdemir RA, Evin R, Irez SG, Korkusuz F. Integrating pilates exercise into an exercise program for 65+ year-old women to reduce falls. J Sports Sci Med. 2011 Mar 1;10(1):105-11. eCollection 2011.

    PMID: 24149302BACKGROUND

  • Endleman I, Critchley DJ. Transversus abdominis and obliquus internus activity during pilates exercises: measurement with ultrasound scanning. Arch Phys Med Rehabil. 2008 Nov;89(11):2205-12. doi: 10.1016/j.apmr.2008.04.025.

    PMID: 18996251BACKGROUND

  • Emery K, De Serres SJ, McMillan A, Cote JN. The effects of a Pilates training program on arm-trunk posture and movement. Clin Biomech (Bristol). 2010 Feb;25(2):124-30. doi: 10.1016/j.clinbiomech.2009.10.003. Epub 2009 Oct 30.

    PMID: 19879677BACKGROUND

  • Queiroz BC, Cagliari MF, Amorim CF, Sacco IC. Muscle activation during four Pilates core stability exercises in quadruped position. Arch Phys Med Rehabil. 2010 Jan;91(1):86-92. doi: 10.1016/j.apmr.2009.09.016.

    PMID: 20103401BACKGROUND

  • Brooks-Brunn JA. Postoperative atelectasis and pneumonia: risk factors. Am J Crit Care. 1995 Sep;4(5):340-9; quiz 350-1.

    PMID: 7489036BACKGROUND

  • Hirschhorn AD, Richards D, Mungovan SF, Morris NR, Adams L. Supervised moderate intensity exercise improves distance walked at hospital discharge following coronary artery bypass graft surgery--a randomised controlled trial. Heart Lung Circ. 2008 Apr;17(2):129-38. doi: 10.1016/j.hlc.2007.09.004. Epub 2007 Dec 3.

    PMID: 18060837BACKGROUND

  • Stein R, Maia CP, Silveira AD, Chiappa GR, Myers J, Ribeiro JP. Inspiratory muscle strength as a determinant of functional capacity early after coronary artery bypass graft surgery. Arch Phys Med Rehabil. 2009 Oct;90(10):1685-91. doi: 10.1016/j.apmr.2009.05.010.

    PMID: 19801057BACKGROUND

  • Hedenstierna G, Edmark L. Mechanisms of atelectasis in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):157-69. doi: 10.1016/j.bpa.2009.12.002.

    PMID: 20608554BACKGROUND

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PMID: 12091180BACKGROUND

  • Hodges PW, Gurfinkel VS, Brumagne S, Smith TC, Cordo PC. Coexistence of stability and mobility in postural control: evidence from postural compensation for respiration. Exp Brain Res. 2002 Jun;144(3):293-302. doi: 10.1007/s00221-002-1040-x. Epub 2002 Apr 13.

    PMID: 12021811BACKGROUND

  • CH Hsu, YC Chung, LY Kuo, JC Chen, FH Chen, HY Huang. Respiratory effects on cardiac rehabilitation combined Pilates exercise in patients underwent cardiac surgery. Formosan Journal of Physical Therapy 2013; 38(3): 210-218

    BACKGROUND

  • Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1--coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S2-22. doi: 10.1016/j.athoracsur.2009.05.053.

    PMID: 19559822RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2015

First Posted

May 7, 2015

Study Start

August 1, 2014

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

May 7, 2015

Record last verified: 2015-04