StrokeNCT02937480
Efficacy of Task-specific Training on Physical Activity Levels Post-stroke
A study testing Task-specific training and Global stretching, memory exercises, health care orientation in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The majority of people after stroke demonstrate mobility limitations, which may reduce their physical activity levels. Task-specific training has shown to be an effective intervention to improve mobility in individuals with stroke, however, little is known about the impact of this intervention on levels of physical… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Task-specific training and Global stretching, memory exercises, health care orientation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a clinical diagnosis of first or recurrent stroke more than six months since the onset of their strokes;
- are older than 19 years of age;
- are able to independently walk 10 m with or without walking aid devices;
- have tone of elbow flexor muscles below 4 on modified Ashworth scale;
- are inactive or insufficient, based on Centers for Disease Control and Prevention criteria;
- get medical permission for physical activity practice
Who cannot join
- have severe cognitive deficits, as assessed by the mini-mental state exam and/or language problems (comprehensive afasia), as evaluated by simple motor commands ("lift your nonparetic upper limb and open your hand"), which might prevent them from following instructions during the data collection and/or the interventions;
- have history of severe heart disease and/or uncontrolled blood pressure;
- have pain and/or other adverse health conditions which might affect the performance in the intervention program, such as vestibular disturbances, severe arthritis, or other neurological disorders.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Efficacy of Task-specific Training on Physical Activity Levels of People With Stroke: A Randomized Controlled Trial
The majority of people after stroke demonstrate mobility limitations, which may reduce their physical activity levels. Task-specific training has shown to be an effective intervention to improve mobility in individuals with stroke, however, little is known about the impact of this intervention on levels of physical activity. The main objective will be to investigate the efficacy of a task-specific training, focused on both upper and lower limbs, in improving physical activity levels and mobility in individuals with stroke. The secondary objective will be to investigate the effect of the training, in improving muscle strength, exercise capacity, and quality of life. A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) experimental group or 2) control group. Participants will receive interventions three times per week over 12 weeks. The experimental group will undertake task-specific training, while the control group will undertake global stretching and memory exercises, and health education sessions. Primary outcomes will include measures of physical activity levels and mobility, whereas secondary outcomes will be muscle strength, exercise capacity, and quality of life. The outcomes will be measured at baseline, 12 weeks post-intervention, and four and 12 weeks follow-up. The findings of this trial have the potential to provide important insights regarding the effects of task-specific training, focused on both upper and lower limbs, in preventing secondary post-stroke complications and improving the participants' general health through changes in physical activity levels.
Read the detailed description
The sample size was calculated to detect a between-group difference of 0.15 m/s in gait speed, with 80% power, at a two-tailed significance level of 0.05. In an RCT with a similar population and intervention (Yang et al. 2006) gait speed for the control and experimental groups at baseline was 0.78±0.14 m/s and 0.84±0.13 m/s and after were 0.78±0.15 m/s (p=0.8) and 0.93±0.14 m/s (p<.001), respectively. Based on these values, 15 participants per group will be required (a total of 30 participants). Assuming a dropout rate of 15%,66 a total of 36 participants will be recruited (18 per group).
Data analyses will be performed by the SPSS for Windows® (release 17.0, SPSS Inc., Chicago, IL, USA). Descriptive statistics will be carried-out for all outcome variables. Differences between the groups at baseline will be investigated with the independent Student's t-tests for all variables related to the demographic and clinical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors.
The effects of the interventions will be analysed in two ways, namely from the data collected and by intention-to-treat analyses, where the last available value in the dropouts will be carried forward to represent the missing data. Analyses of variance with repeated measures (2×4) will be employed to investigate the mean and interaction effects between the groups (intervention×control) and the time (preintervention, postintervention, and follow-up) for the primary and secondary outcomes. Group descriptions will be presented as mean (SD) and effect sizes with 95% confidence intervals (CIs) will be reported.
The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.
- Conditions
- Stroke
- Being tested
- Task-specific training, Global stretching, memory exercises, health care orientation
- Keywords
- stroke, physical activity, task performance, clinical protocol
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-specific trainingOther
Also called Task-oriented training
The task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training.
Global stretching, memory exercises, health care orientationOther
The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Task-specific training Receives: Other: Task-specific training |
| Control group | Sham comparator | Global stretching, memory exercises, health care orientation Receives: Other: Global stretching, memory exercises, health care orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Physical activity levels - physical activity monitor
Physical activity levels will be assessed by a physical activity monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Physical activity levels - Human Activity Profile
Physical activity levels will be assessed by Human Activity Profile.
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Mobility - Gait speed
Mobility will be assessed by gait speed.
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Mobility - TEMPA
Mobility will be assessed by TEMPA test.
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Secondary outcomes (3)
Change from baseline in Muscle strength
Muscle strength will be assessed by hydraulic handgrip dynamometer SAEHAN® (SAEHAN Corporation, Korea, Model SH5001) and digital handheld dynamometer Microfet2® (Hoggan Health Industries, UT, USA).
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Exercise capacity
Exercise capacity will be assessed by six minute walk test.
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Quality of life
Quality of life will be assessed by Stroke specific quality of life.
Measured: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
- Investigators
- Christina Danielli CM Faria, Doctor, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937480
- Sponsor's protocol ID
- CAAE: 51453915.1.0000.5149
- Status last verified
- Dec 2019
- First submitted
- 18 Sep 2016
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendis S. Stroke disability and rehabilitation of stroke: World Health Organization perspective. Int J Stroke. 2013 Jan;8(1):3-4. doi: 10.1111/j.1747-4949.2012.00969.x. No abstract available.
PubMed 23280261Ovbiagele B, Goldstein LB, Higashida RT, Howard VJ, Johnston SC, Khavjou OA, Lackland DT, Lichtman JH, Mohl S, Sacco RL, Saver JL, Trogdon JG; American Heart Association Advocacy Coordinating Committee and Stroke Council. Forecasting the future of stroke in the United States: a policy statement from the American Heart Association and American Stroke Association. Stroke. 2013 Aug;44(8):2361-75. doi: 10.1161/STR.0b013e31829734f2. Epub 2013 May 22.
PubMed 23697546Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
PubMed 24846875Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
PubMed 24788967Martins SC, Pontes-Neto OM, Alves CV, de Freitas GR, Filho JO, Tosta ED, Cabral NL; Brazilian Stroke Network. Past, present, and future of stroke in middle-income countries: the Brazilian experience. Int J Stroke. 2013 Oct;8 Suppl A100:106-11. doi: 10.1111/ijs.12062. Epub 2013 May 22.
PubMed 23692595Morris JH, Macgillivray S, McFarlane S. Interventions to promote long-term participation in physical activity after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2014 May;95(5):956-67. doi: 10.1016/j.apmr.2013.12.016. Epub 2014 Jan 1.
PubMed 24389402Fini NA, Holland AE, Keating J, Simek J, Bernhardt J. How is physical activity monitored in people following stroke? Disabil Rehabil. 2015;37(19):1717-31. doi: 10.3109/09638288.2014.978508. Epub 2014 Nov 6.
PubMed 25374044Resnick B, Michael K, Shaughnessy M, Nahm ES, Kobunek S, Sorkin J, Orwig D, Goldberg A, Macko RF. Inflated perceptions of physical activity after stroke: pairing self-report with physiologic measures. J Phys Act Health. 2008 Mar;5(2):308-18. doi: 10.1123/jpah.5.2.308.
PubMed 18382039Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
PubMed 3920711Strath SJ, Kaminsky LA, Ainsworth BE, Ekelund U, Freedson PS, Gary RA, Richardson CR, Smith DT, Swartz AM; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health and Cardiovascular, Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, and Council. Guide to the assessment of physical activity: Clinical and research applications: a scientific statement from the American Heart Association. Circulation. 2013 Nov 12;128(20):2259-79. doi: 10.1161/01.cir.0000435708.67487.da. Epub 2013 Oct 14.
PubMed 24126387Warren JM, Ekelund U, Besson H, Mezzani A, Geladas N, Vanhees L; Experts Panel. Assessment of physical activity - a review of methodologies with reference to epidemiological research: a report of the exercise physiology section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):127-39. doi: 10.1097/HJR.0b013e32832ed875.
PubMed 20215971Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
PubMed 24756870Chae J, Johnston M, Kim H, Zorowitz R. Admission motor impairment as a predictor of physical disability after stroke rehabilitation. Am J Phys Med Rehabil. 1995 May-Jun;74(3):218-23. doi: 10.1097/00002060-199505000-00007.
PubMed 7779333Ashe MC, Miller WC, Eng JJ, Noreau L; Physical Activity and Chronic Conditions Research Team. Older adults, chronic disease and leisure-time physical activity. Gerontology. 2009;55(1):64-72. doi: 10.1159/000141518. Epub 2008 Jun 20.
PubMed 18566534English C, Hillier SL. Circuit class therapy for improving mobility after stroke. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD007513. doi: 10.1002/14651858.CD007513.pub2.
PubMed 20614460
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Task-specific Training on Physical Activity Levels of People With Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02937480
- Acronym / sponsor ID
- CAAE: 51453915.1.0000.5149
- Conditions
- Stroke
- Keywords
- stroke, physical activity, task performance, clinical protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Oct 2016 (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 majority of people after stroke demonstrate mobility limitations, which may reduce their physical activity levels. Task-specific training has shown to be an effective intervention to improve mobility in individuals with stroke, however, little is known about the impact of this intervention on levels of physical activity. The main objective will be to investigate the efficacy of a task-specific training, focused on both upper and lower limbs, in improving physical activity levels and mobility in individuals with stroke. The secondary objective will be to investigate the effect of the training, in improving muscle strength, exercise capacity, and quality of life. A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) experimental group or 2) control group. Participants will receive interventions three times per week over 12 weeks. The experimental group will undertake task-specific training, while the control group will undertake global stretching and memory exercises, and health education sessions. Primary outcomes will include measures of physical activity levels and mobility, whereas secondary outcomes will be muscle strength, exercise capacity, and quality of life. The outcomes will be measured at baseline, 12 weeks post-intervention, and four and 12 weeks follow-up. The findings of this trial have the potential to provide important insights regarding the effects of task-specific training, focused on both upper and lower limbs, in preventing secondary post-stroke complications and improving the participants' general health through changes in physical activity levels.
Detailed description
The sample size was calculated to detect a between-group difference of 0.15 m/s in gait speed, with 80% power, at a two-tailed significance level of 0.05. In an RCT with a similar population and intervention (Yang et al. 2006) gait speed for the control and experimental groups at baseline was 0.78±0.14 m/s and 0.84±0.13 m/s and after were 0.78±0.15 m/s (p=0.8) and 0.93±0.14 m/s (p<.001), respectively. Based on these values, 15 participants per group will be required (a total of 30 participants). Assuming a dropout rate of 15%,66 a total of 36 participants will be recruited (18 per group).
Data analyses will be performed by the SPSS for Windows® (release 17.0, SPSS Inc., Chicago, IL, USA). Descriptive statistics will be carried-out for all outcome variables. Differences between the groups at baseline will be investigated with the independent Student's t-tests for all variables related to the demographic and clinical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors.
The effects of the interventions will be analysed in two ways, namely from the data collected and by intention-to-treat analyses, where the last available value in the dropouts will be carried forward to represent the missing data. Analyses of variance with repeated measures (2×4) will be employed to investigate the mean and interaction effects between the groups (intervention×control) and the time (preintervention, postintervention, and follow-up) for the primary and secondary outcomes. Group descriptions will be presented as mean (SD) and effect sizes with 95% confidence intervals (CIs) will be reported.
The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Task-specific trainingTask-specific training |
| Control group | Sham comparator | Other: Global stretching, memory exercises, health care orientationGlobal stretching, memory exercises, health care orientation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have a clinical diagnosis of first or recurrent stroke more than six months since the onset of their strokes;
- are older than 19 years of age;
- are able to independently walk 10 m with or without walking aid devices;
- have tone of elbow flexor muscles below 4 on modified Ashworth scale;
- are inactive or insufficient, based on Centers for Disease Control and Prevention criteria;
Key exclusion criteria (3 listed)
- have severe cognitive deficits, as assessed by the mini-mental state exam and/or language problems (comprehensive afasia), as evaluated by simple motor commands ("lift your nonparetic upper limb and open your hand"), which might prevent them from following instructions during the data collection and/or the interventions;
- have history of severe heart disease and/or uncontrolled blood pressure;
- have pain and/or other adverse health conditions which might affect the performance in the intervention program, such as vestibular disturbances, severe arthritis, or other neurological disorders.
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 |
|---|---|---|
| Task-specific trainingAlso: Task-oriented trainingThe task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training. | Other | Experimental group |
| Global stretching, memory exercises, health care orientationThe control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation | Other | Control group |
Primary outcome
Change from baseline in Physical activity levels - physical activity monitor
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Physical activity levels will be assessed by a physical activity monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
Change from baseline in Physical activity levels - Human Activity Profile
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Physical activity levels will be assessed by Human Activity Profile.
Change from baseline in Mobility - Gait speed
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Mobility will be assessed by gait speed.
Change from baseline in Mobility - TEMPA
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Mobility will be assessed by TEMPA test.
3 secondary outcomes
Change from baseline in Muscle strength
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Exercise capacity
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
Change from baseline in Quality of life
Time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up
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 17 Dec 2019.
- Background: PubMed 23280261Mendis S. Stroke disability and rehabilitation of stroke: World Health Organization perspective. Int J Stroke. 2013 Jan;8(1):3-4. doi: 10.1111/j.1747-4949.2012.00969.x. No abstract available.
- Background: PubMed 23697546Ovbiagele B, Goldstein LB, Higashida RT, Howard VJ, Johnston SC, Khavjou OA, Lackland DT, Lichtman JH, Mohl S, Sacco RL, Saver JL, Trogdon JG; American Heart Association Advocacy Coordinating Committee and Stroke Council. Forecasting the future of stroke in the United States: a policy statement from the American Heart Association and American Stroke Association. Stroke. 2013 Aug;44(8):2361-75. doi: 10.1161/STR.0b013e31829734f2. Epub 2013 May 22.
- Background: PubMed 24846875Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
- Background: PubMed 24788967Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
- Background: PubMed 23692595Martins SC, Pontes-Neto OM, Alves CV, de Freitas GR, Filho JO, Tosta ED, Cabral NL; Brazilian Stroke Network. Past, present, and future of stroke in middle-income countries: the Brazilian experience. Int J Stroke. 2013 Oct;8 Suppl A100:106-11. doi: 10.1111/ijs.12062. Epub 2013 May 22.
- Background: PubMed 24389402Morris JH, Macgillivray S, McFarlane S. Interventions to promote long-term participation in physical activity after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2014 May;95(5):956-67. doi: 10.1016/j.apmr.2013.12.016. Epub 2014 Jan 1.
- Background: PubMed 25374044Fini NA, Holland AE, Keating J, Simek J, Bernhardt J. How is physical activity monitored in people following stroke? Disabil Rehabil. 2015;37(19):1717-31. doi: 10.3109/09638288.2014.978508. Epub 2014 Nov 6.
- Background: PubMed 18382039Resnick B, Michael K, Shaughnessy M, Nahm ES, Kobunek S, Sorkin J, Orwig D, Goldberg A, Macko RF. Inflated perceptions of physical activity after stroke: pairing self-report with physiologic measures. J Phys Act Health. 2008 Mar;5(2):308-18. doi: 10.1123/jpah.5.2.308.
- Background: PubMed 3920711Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
- Background: PubMed 24126387Strath SJ, Kaminsky LA, Ainsworth BE, Ekelund U, Freedson PS, Gary RA, Richardson CR, Smith DT, Swartz AM; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health and Cardiovascular, Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, and Council. Guide to the assessment of physical activity: Clinical and research applications: a scientific statement from the American Heart Association. Circulation. 2013 Nov 12;128(20):2259-79. doi: 10.1161/01.cir.0000435708.67487.da. Epub 2013 Oct 14.
- Background: PubMed 20215971Warren JM, Ekelund U, Besson H, Mezzani A, Geladas N, Vanhees L; Experts Panel. Assessment of physical activity - a review of methodologies with reference to epidemiological research: a report of the exercise physiology section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):127-39. doi: 10.1097/HJR.0b013e32832ed875.
- Background: PubMed 24756870Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
- Individual participant dataSharing planned: No
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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.
Christina Danielli CM Faria, Doctor principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-specific training and Global stretching, memory exercises, health care orientation in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
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 6 inclusion and 3 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 17 Dec 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in Physical activity levels - physical activity monitor (time frame: At baseline, after 12 weeks post-intervention, four and 12 weeks of follow-up). The study lists 4 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 NCT02937480, which also lists 28 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 17 Dec 2019.