- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01396746
Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke
Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests in Persons With Post Stroke Conditions
The purpose of this study is to explore the relationship between cardiovascular function of persons with post stroke conditions and their performance in three field tests. This is a validation study, aiming to determine during which of two activities VO2 measurements better express the functional restrictions caused by stroke, And to find out whether the Total Heart Beat Index can be used in the case of stroke survivors for the prediction of mechanical efficiency when measured during stair-climbing and of energy cost during treadmill walking.
The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of external work, and therefore will show stronger correlation with functional tests demonstrating the same ability, whereas TMW does not utilize the movement capability of participants to the fullest.
Another hypothesis is that cardiac response to the exertion can be used as a predictor of those measures during these exertions in the post stroke population.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ramat Gan, Israel
- Recruiting
- Israel Sport Center for the Disabled
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Contact:
- Yeshayahu Hutzler, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having acquired stroke at least 1 year before testing
- Chronic weakness and/or spasticity of the affected side
- Independent stair-climbers (with hand-rail)
- Received medical clearance from a physician
- With cognitive level sufficient to comprehend instructions
- Participants' age will range between 40-69
- Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail.
Exclusion Criteria:
- Unable to understand instructions
- Unable to ambulate
- Severe aphasia
- Heart failure or other medical conditions that preclude participation in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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People with Post Stroke Conditions
(a) having acquired stroke at least 1 year before testing.
(b) Chronic weakness and/or spasticity of the affected side.
(c) Independent stair-climbers (with hand-rail).
(d) With cognitive level sufficient to comprehend instructions.
(e) age range between 40-69.
(f) Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail.
(g) No heart failure or other medical conditions that preclude participation in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exercise VO2
Time Frame: 60 days
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60 days
|
Exercise HR
Time Frame: 60 days
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60 days
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Mechanical efficiency
Time Frame: 60 days
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60 days
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Time for-Up-and-go (TUG) Test
Time Frame: 60 days
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60 days
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Time for 10 m walk test
Time Frame: 60 days
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60 days
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Distance for 6 min walk test
Time Frame: 60 days
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60 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Yeshayahu Hutzler, Dr., The Wingate Institute for Physical Education and Sports
- Principal Investigator: Avraham Katz, MD, Israel Sport Center for the Disabled
- Study Director: Galia Modai, The Wingate Institute for Physical Education and Sports
Publications and helpful links
General Publications
- 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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
- Pohl M, Mehrholz J, Ritschel C, Ruckriem S. Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Stroke. 2002 Feb;33(2):553-8. doi: 10.1161/hs0202.102365.
- Crenna P. Spasticity and 'spastic' gait in children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):571-8. doi: 10.1016/s0149-7634(97)00046-8.
- Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.
- Waters RL, Mulroy S. The energy expenditure of normal and pathologic gait. Gait Posture. 1999 Jul;9(3):207-31. doi: 10.1016/s0966-6362(99)00009-0.
- Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Physical activity and exercise recommendations for stroke survivors: an American Heart Association scientific statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Circulation. 2004 Apr 27;109(16):2031-41. doi: 10.1161/01.CIR.0000126280.65777.A4. No abstract available.
- Mathias S, Nayak US, Isaacs B. Balance in elderly patients: the "get-up and go" test. Arch Phys Med Rehabil. 1986 Jun;67(6):387-9.
- Fulk GD, Echternach JL, Nof L, O'Sullivan S. Clinometric properties of the six-minute walk test in individuals undergoing rehabilitation poststroke. Physiother Theory Pract. 2008 May-Jun;24(3):195-204. doi: 10.1080/09593980701588284.
- Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.
- Andriacchi TP, Andersson GB, Fermier RW, Stern D, Galante JO. A study of lower-limb mechanics during stair-climbing. J Bone Joint Surg Am. 1980 Jul;62(5):749-57.
- Bar-Haim S, Belokopytov M, Harries N, Loeppky JA, Kaplanski J. Prediction of mechanical efficiency from heart rate during stair-climbing in children with cerebral palsy. Gait Posture. 2008 Apr;27(3):512-7. doi: 10.1016/j.gaitpost.2007.06.006. Epub 2007 Aug 8.
- Bowen TR, Lennon N, Castagno P, Miller F, Richards J. Variability of energy-consumption measures in children with cerebral palsy. J Pediatr Orthop. 1998 Nov-Dec;18(6):738-42.
- Carvalho C, Willen C, Sunnerhagen KS. Relationship between walking function and 1-legged bicycling test in subjects in the later stage post-stroke. J Rehabil Med. 2008 Oct;40(9):721-6. doi: 10.2340/16501977-0242.
- Chen G, Patten C, Kothari DH, Zajac FE. Gait differences between individuals with post-stroke hemiparesis and non-disabled controls at matched speeds. Gait Posture. 2005 Aug;22(1):51-6. doi: 10.1016/j.gaitpost.2004.06.009.
- Crompton S, Khemlani M, Batty J, Ada L, Dean C, Katrak P. Practical issues in retraining walking in severely disabled patients using treadmill and harness support systems. Aust J Physiother. 2001;47(3):211-3. doi: 10.1016/s0004-9514(14)60268-3. No abstract available.
- da Cunha-Filho IT, Henson H, Wankadia S, Protas EJ. Reliability of measures of gait performance and oxygen consumption with stroke survivors. J Rehabil Res Dev. 2003 Jan-Feb;40(1):19-25.
- de Oliveira CB, de Medeiros IR, Frota NA, Greters ME, Conforto AB. Balance control in hemiparetic stroke patients: main tools for evaluation. J Rehabil Res Dev. 2008;45(8):1215-26.
- Detrembleur C, Dierick F, Stoquart G, Chantraine F, Lejeune T. Energy cost, mechanical work, and efficiency of hemiparetic walking. Gait Posture. 2003 Oct;18(2):47-55. doi: 10.1016/s0966-6362(02)00193-5.
- Donnan GA, Davis SM. Breaking the 3 h barrier for treatment of acute ischaemic stroke. Lancet Neurol. 2008 Nov;7(11):981-2. doi: 10.1016/S1474-4422(08)70230-8. No abstract available.
- Gordon NF, Duncan JJ. Effect of beta-blockers on exercise physiology: implications for exercise training. Med Sci Sports Exerc. 1991 Jun;23(6):668-76.
- Hood VL, Granat MH, Maxwell DJ, Hasler JP. A new method of using heart rate to represent energy expenditure: the Total Heart Beat Index. Arch Phys Med Rehabil. 2002 Sep;83(9):1266-73. doi: 10.1053/apmr.2002.34598.
- Kelly-Hayes M, Robertson JT, Broderick JP, Duncan PW, Hershey LA, Roth EJ, Thies WH, Trombly CA. The American Heart Association Stroke Outcome Classification. Stroke. 1998 Jun;29(6):1274-80. doi: 10.1161/01.str.29.6.1274. No abstract available.
- Kollen B, van de Port I, Lindeman E, Twisk J, Kwakkel G. Predicting improvement in gait after stroke: a longitudinal prospective study. Stroke. 2005 Dec;36(12):2676-80. doi: 10.1161/01.STR.0000190839.29234.50. Epub 2005 Nov 10.
- Lamontagne A, Stephenson JL, Fung J. Physiological evaluation of gait disturbances post stroke. Clin Neurophysiol. 2007 Apr;118(4):717-29. doi: 10.1016/j.clinph.2006.12.013. Epub 2007 Feb 16.
- Lord SE, Rochester L. Measurement of community ambulation after stroke: current status and future developments. Stroke. 2005 Jul;36(7):1457-61. doi: 10.1161/01.STR.0000170698.20376.2e. Epub 2005 Jun 9.
- Meyring S, Diehl RR, Milani TL, Hennig EM, Berlit P. Dynamic plantar pressure distribution measurements in hemiparetic patients. Clin Biomech (Bristol, Avon). 1997 Jan;12(1):60-65. doi: 10.1016/s0268-0033(96)00050-2.
- IJzerman MJ, Baardman G, van 't Hof MA, Boom HB, Hermens HJ, Veltink PH. Validity and reproducibility of crutch force and heart rate measurements to assess energy expenditure of paraplegic gait. Arch Phys Med Rehabil. 1999 Sep;80(9):1017-23. doi: 10.1016/s0003-9993(99)90054-0.
- Nakamura R, Handa T, Watanabe S, Morohashi I. Walking cycle after stroke. Tohoku J Exp Med. 1988 Mar;154(3):241-4. doi: 10.1620/tjem.154.241.
- Neptune RR, Sasaki K, Kautz SA. The effect of walking speed on muscle function and mechanical energetics. Gait Posture. 2008 Jul;28(1):135-43. doi: 10.1016/j.gaitpost.2007.11.004. Epub 2007 Dec 26.
- Pang MY, Eng JJ, Dawson AS. Relationship between ambulatory capacity and cardiorespiratory fitness in chronic stroke: influence of stroke-specific impairments. Chest. 2005 Feb;127(2):495-501. doi: 10.1378/chest.127.2.495.
- Perron M, Malouin F, Moffet H. Assessing advanced locomotor recovery after total hip arthroplasty with the timed stair test. Clin Rehabil. 2003 Nov;17(7):780-6. doi: 10.1191/0269215503cr696oa.
- Perry J. The mechanics of walking in hemiplegia. Clin Orthop Relat Res. 1969 Mar-Apr;63:23-31. No abstract available.
- Pizzi A, Carlucci G, Falsini C, Lunghi F, Verdesca S, Grippo A. Gait in hemiplegia: evaluation of clinical features with the Wisconsin Gait Scale. J Rehabil Med. 2007 Mar;39(2):170-4. doi: 10.2340/16501977-0026.
- Pohl PS, Duncan PW, Perera S, Liu W, Lai SM, Studenski S, Long J. Influence of stroke-related impairments on performance in 6-minute walk test. J Rehabil Res Dev. 2002 Jul-Aug;39(4):439-44.
- Raine AE, Pickering TG. Cardiovascular and sympathetic response to exercise after long-term beta-adrenergic blockade. Br Med J. 1977 Jul 9;2(6079):90-2. doi: 10.1136/bmj.2.6079.90.
- RALSTON HJ. Energy-speed relation and optimal speed during level walking. Int Z Angew Physiol. 1958;17(4):277-83. doi: 10.1007/BF00698754. No abstract available.
- Sims NR, Muyderman H. Mitochondria, oxidative metabolism and cell death in stroke. Biochim Biophys Acta. 2010 Jan;1802(1):80-91. doi: 10.1016/j.bbadis.2009.09.003. Epub 2009 Sep 12.
- Tang A, Sibley KM, Bayley MT, McIlroy WE, Brooks D. Do functional walk tests reflect cardiorespiratory fitness in sub-acute stroke? J Neuroeng Rehabil. 2006 Sep 29;3:23. doi: 10.1186/1743-0003-3-23.
- Teixeira-Salmela LF, Nadeau S, Mcbride I, Olney SJ. Effects of muscle strengthening and physical conditioning training on temporal, kinematic and kinetic variables during gait in chronic stroke survivors. J Rehabil Med. 2001 Mar;33(2):53-60. doi: 10.1080/165019701750098867.
- van de Port IG, Wood-Dauphinee S, Lindeman E, Kwakkel G. Effects of exercise training programs on walking competency after stroke: a systematic review. Am J Phys Med Rehabil. 2007 Nov;86(11):935-51. doi: 10.1097/PHM.0b013e31802ee464.
- Vanhees L, Fagard R, Amery A. Influence of beta adrenergic blockade on effects of physical training in patients with ischaemic heart disease. Br Heart J. 1982 Jul;48(1):33-8. doi: 10.1136/hrt.48.1.33.
- von Schroeder HP, Coutts RD, Lyden PD, Billings E Jr, Nickel VL. Gait parameters following stroke: a practical assessment. J Rehabil Res Dev. 1995 Feb;32(1):25-31.
- Werner C, Von Frankenberg S, Treig T, Konrad M, Hesse S. Treadmill training with partial body weight support and an electromechanical gait trainer for restoration of gait in subacute stroke patients: a randomized crossover study. Stroke. 2002 Dec;33(12):2895-901. doi: 10.1161/01.str.0000035734.61539.f6.
- Wevers L, van de Port I, Vermue M, Mead G, Kwakkel G. Effects of task-oriented circuit class training on walking competency after stroke: a systematic review. Stroke. 2009 Jul;40(7):2450-9. doi: 10.1161/STROKEAHA.108.541946. Epub 2009 May 21.
- Zamparo P, Francescato MP, De Luca G, Lovati L, di Prampero PE. The energy cost of level walking in patients with hemiplegia. Scand J Med Sci Sports. 1995 Dec;5(6):348-52. doi: 10.1111/j.1600-0838.1995.tb00057.x.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54-2011
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