StrokeNCT01396746
Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke
An observational study of Stroke and Hemiplegia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Stroke, Hemiplegia
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to not given
- Phase
- Observational
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are recruited in community centers designated for Disabled populations. They are leading a physically active life style, usually facilitated by an assistant.
Who may be able to join
- 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.
Who cannot join
- Unable to understand instructions
- Unable to ambulate
- Severe aphasia
- Heart failure or other medical conditions that preclude participation in the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Israel Sport Center for the Disabled
Ramat Gan
Yeshayahu Hutzler, Dr.
About this study
Official title: 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.
- Conditions
- Stroke, Hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise VO2
Measured: 60 days
Exercise HR
Measured: 60 days
Mechanical efficiency
Measured: 60 days
Time for-Up-and-go (TUG) Test
Measured: 60 days
Time for 10 m walk test
Measured: 60 days
Distance for 6 min walk test
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Zinman College of Physical Education and Sports Sciences, Israel Sport Center for the Disabled
- Investigators
- Yeshayahu Hutzler, Dr., Study chair, The Wingate institute for physical education and sportsAvraham Katz, MD, Principal investigator, Israel Sport Center for the DisabledGalia Modai, Study director, The Wingate Institute for Physical Education and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396746
- Sponsor's protocol ID
- 54-2011
- Status last verified
- Jul 2011
- First submitted
- 28 Jun 2011
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 7391098ATS 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.
PubMed 12091180Bar-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.
PubMed 17689964Berg 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.
PubMed 1468055Blum 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.
PubMed 18292215Bowen 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.
PubMed 9821128Carvalho 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.
PubMed 18843423Chen 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.
PubMed 15996592Crenna 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.
PubMed 9595571Crompton 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.
PubMed 11552877da 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.
PubMed 15150717de 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.
PubMed 19235121Detrembleur 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.
PubMed 14654207Donnan 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.
PubMed 18940690Duncan 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.
PubMed 17996052
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests in Persons With Post Stroke Conditions
- ClinicalTrials.gov ID
- NCT01396746
- Acronym / sponsor ID
- 54-2011
- Conditions
- Stroke, Hemiplegia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Zinman College of Physical Education and Sports Sciences, Israel Sport Center for the Disabled
- Study start
- Jun 2011
- First posted
- 19 Jul 2011 (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 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited in community centers designated for Disabled populations. They are leading a physically active life style, usually facilitated by an assistant.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Unable to understand instructions
- Unable to ambulate
- Severe aphasia
- Heart failure or other medical conditions that preclude participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise VO2
Time frame: 60 days
Exercise HR
Time frame: 60 days
Mechanical efficiency
Time frame: 60 days
Time for-Up-and-go (TUG) Test
Time frame: 60 days
Time for 10 m walk test
Time frame: 60 days
Distance for 6 min walk test
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
- Background: PubMed 7391098Andriacchi 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.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 17689964Bar-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.
- Background: PubMed 1468055Berg 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.
- Background: PubMed 18292215Blum 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.
- Background: PubMed 9821128Bowen 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.
- Background: PubMed 18843423Carvalho 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.
- Background: PubMed 15996592Chen 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.
- Background: PubMed 9595571Crenna 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.
- Background: PubMed 11552877Crompton 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.
- Background: PubMed 15150717da 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.
- Background: PubMed 19235121de 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.
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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.
Yeshayahu Hutzler, Dr. study chair
The Wingate institute for physical education and sports
Avraham Katz, MD principal investigator
Israel Sport Center for the Disabled
Galia Modai study director
The Wingate Institute for Physical Education and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiplegia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 7 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 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Galia Modai (972-54-6477737, galiamodai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise VO2 (time frame: 60 days). The study lists 6 primary outcomes in all. 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 NCT01396746, which also lists 46 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 19 Jul 2011.