Effectiveness of Therapeutic Exercise Combined With Respiratory Muscle Training in Patients With Subacute Stroke
NCT ID: NCT06949839
Last Updated: 2025-04-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
64 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-04-30
Study Completion Date
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Stroke has a significant impact on morbidity, mortality and healthcare expenditure globally. In addition to the motor and cognitive consequences, as well as on functional independence and social participation, it can produce alterations in the respiratory function. Scientific evidence supports the application of both therapeutic exercise programs and respiratory muscle training (RMT). However, studies that combine both interventions are limited, and to date no study has been published that examines the effectiveness of this combination in the subacute phase of stroke, which is the one that presents the widest range of neuroplasticity. Objectives: To analyze the effects of a combined therapeutic exercise and RMT program, compared to the therapeutic exercise and sham RMT program, on different variables related to functional, respiratory, swallowing and speech/voice capacity, in patients in the subacute phase of a stroke. Type of research: double-blind randomized controlled clinical trial. Design: The study will be carried out at the University Hospital Complex of A Coruña (CHUAC), where 64 patients with more than three and less than six months of evolution after a stroke will be recruited. Participants will be randomly assigned to two groups: the intervention group will perform a combined therapeutic exercise and RMT program, while the control group will combine the same therapeutic exercise program and sham RMT. The duration of the intervention will be eight weeks. The therapeutic exercise program will be carried out three days per week and will consist of a cardiovascular exercise part and a strength-endurance part. The RMT protocol will involve both the inspiratory and expiratory muscles, using the Orygen-Dual Valve® device. The control group will use the same valve but without resistance, generating a sham RMT. It will have a frequency of five days per week and will be carried out at the home of each patient. Additionally, half the subjects in the intervention group will continue the RMT protocol once the eight-week period has ended, with a frequency of two days per week, until the six-month follow-up. Possible differences between groups will be analyzed before and after the intervention, and at three and six months of follow-up, in relation to the following domains: functional capacity, functional independence, lung and respiratory muscle function, swallowing and speech/voice function, respiratory signs and symptoms, and quality of life.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Home-based Respiratory Training After Stroke
NCT02400138
Stroke
COMPLETED
NA
Functional Massage and Eccentric Exercise in Stroke Survivors (FM-EE Stroke)
NCT06922149
Stroke
COMPLETED
NA
Efficacy of Task-specific Training on Physical Activity Levels Post-stroke
NCT02937480
Stroke
COMPLETED
NA
Ventilatory Muscle Training in Stroke
NCT02828943
Stroke
Pulmonary Ventilation
Exercise Therapy
COMPLETED
PHASE3
Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients
NCT00778453
Cerebrovascular Accidents
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This protocol is designed to analyze the effects of a therapeutic exercise program combined with an RMT protocol in patients with subacute stroke, compared to another group that will perform the therapeutic exercise program combined with sham RMT in relation to different functional variables.
Sample size assessment: The sample size calculation was performed using the G\*Power software and based on the 6 Minute Walk Test (6MWT), chosen as the main variable. The minimum clinically important difference (MCID) data from the study by Fulk et al. (MCID=130) and the standard deviation (SD) from the study by Baker et al. (conducted in patients with subacute stroke in the United Kingdom, SD=143) were used. For a two-sided hypothesis, with a statistical power of 90% and a significance level of 0.05, a sample size of 32 subjects per group would be required (assuming a 20% loss over the course of the study). Additionally, a pilot phase will be developed at the beginning of the study with eight other subjects who will not be part of the final sample, in order study the feasibility of the project.
Plan for missing data: At the end of each assessment session, all questionnaires will be checked to ensure they are complete and filled out correctly. If a participant does not attend a session, they will be phone called and rescheduled for that session. In cases where data are reported as missing, unavailable, or uninterpretable due to inconsistencies or out-of-range results, a plan will be implemented to manage these cases. Strategies will include imputing missing data and excluding cases.
Statistical analysis plan: Anaconda® software and the Python 3.8.8 programming language will be used. A descriptive analysis of the variables included in the study will be performed initially. For qualitative variables, absolute frequencies and percentages will be presented, and for quantitative variables, measures of central tendency (mean/median) and dispersion (range/standard deviation) will be presented, depending on whether they are normal or non-normal. The normality of the sample will be tested using the Shapiro-Wilk test. Per-protocol and intention-to-treat analyses will be performed to determine the effectiveness of the treatment both under ideal conditions of protocol adherence and in a more realistic context of losses throughout the intervention. To compare the results of the outcome measures between the study groups throughout the intervention, a repeated-measures ANOVA will be applied with a within-subject factor, time, which has four levels (pre-training, post-training, and at three and six months post-training), and a between-subject factor, the type of intervention (therapeutic exercise + RMT or therapeutic exercise + sham RMT). Another repeated-measures ANOVA will be applied with the same within-subject factor, and the presence or absence of maintenance sessions as a between-subject factor (only for the intervention group). The level of statistical significance will be set at p\<0.05.
Sample size assessment: The sample size calculation was performed using the G\*Power software and based on the 6 Minute Walk Test (6MWT), chosen as the main variable. The minimum clinically important difference (MCID) data from the study by Fulk et al. (MCID=130) and the standard deviation (SD) from the study by Baker et al. (conducted in patients with subacute stroke in the United Kingdom, SD=143) were used. For a two-sided hypothesis, with a statistical power of 90% and a significance level of 0.05, a sample size of 32 subjects per group would be required (assuming a 20% loss over the course of the study). Additionally, a pilot phase will be developed at the beginning of the study with eight other subjects who will not be part of the final sample, in order study the feasibility of the project.
Plan for missing data: At the end of each assessment session, all questionnaires will be checked to ensure they are complete and filled out correctly. If a participant does not attend a session, they will be phone called and rescheduled for that session. In cases where data are reported as missing, unavailable, or uninterpretable due to inconsistencies or out-of-range results, a plan will be implemented to manage these cases. Strategies will include imputing missing data and excluding cases.
Statistical analysis plan: Anaconda® software and the Python 3.8.8 programming language will be used. A descriptive analysis of the variables included in the study will be performed initially. For qualitative variables, absolute frequencies and percentages will be presented, and for quantitative variables, measures of central tendency (mean/median) and dispersion (range/standard deviation) will be presented, depending on whether they are normal or non-normal. The normality of the sample will be tested using the Shapiro-Wilk test. Per-protocol and intention-to-treat analyses will be performed to determine the effectiveness of the treatment both under ideal conditions of protocol adherence and in a more realistic context of losses throughout the intervention. To compare the results of the outcome measures between the study groups throughout the intervention, a repeated-measures ANOVA will be applied with a within-subject factor, time, which has four levels (pre-training, post-training, and at three and six months post-training), and a between-subject factor, the type of intervention (therapeutic exercise + RMT or therapeutic exercise + sham RMT). Another repeated-measures ANOVA will be applied with the same within-subject factor, and the presence or absence of maintenance sessions as a between-subject factor (only for the intervention group). The level of statistical significance will be set at p\<0.05.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Stroke
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomly assigned to two groups: the intervention group will perform a combined therapeutic exercise and RMT program, while the control group will combine the same therapeutic exercise program and sham RMT. The duration of the intervention (to both groups) will be eight weeks. The therapeutic exercise program will be carried out three days per week at the CHUAC hospital, and the RMT protocol will be carried out at the home of each patient five days per week, with on-site follow-up every 10 days at the CHUAC. Additionally, half of the subjects from the intervention group will continue the RMT protocol once the eight-week period has ended, with a frequency of two days per week and until the six-month follow-up.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
All participants, regardless of their group, will perform the same therapeutic exercise program. In addition, they will not know whether their RMT device is sham or not (they have the same appearance). One researcher (physical therapist) will perform both the outcomes assessment and the therapeutic exercise intervention and will be blinded to the group assignment of the patients to the intervention group or the control group. Another researcher (speech therapist) will be responsible for delivering the RMT and sham RMT devices based on the randomization and instructing the patients in their use, as well as increasing the resistance of the valve and re-evaluating the execution of the protocol to confirm that it is being carried out correctly. Therefore, this last therapist will be the only one who will know the group assignments. Mechanisms will be applied to verify whether the masking of both the physiotherapist and the patients to the groups has been violated at any time.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Intervention group will perform a therapeutic exercise program combined with RMT
Group Type
EXPERIMENTAL
Therapeutic exercise program combined with RMT
Intervention Type
DEVICE
For the RMT protocol, the Orygen-dual valve® device will be used. Each participant will start with a load of 30% of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Once every 10 days, the performance will be reviewed and the resistance will be increased by 10cmH2O of the initial MIP/MEP of each patient. Each session will consist of breathing through the device for 20 minutes (10 minutes dedicated to each muscle group). This process will be repeated once a day, five days a week, for eight weeks.
The therapeutic exercise program will be common to both groups and will be carried out at CHUAC hospital, in group sessions. The sessions will be held three days a week, for eight weeks. Each session will consist of a 10-minute warm-up part, 45 minutes of the main part (aerobic and strength-resistance exercise), and five minutes of cooling down.
Control group
Control group will perform the same therapeutic exercise program combined with sham RMT
Group Type
SHAM_COMPARATOR
Therapeutic exercise program combined with sham RMT
Intervention Type
DEVICE
The sham RMT protocol will have the same frequency as in the intervention group. The therapeutic exercise program will be common to both groups and will be carried out at CHUAC hospital, in group sessions. The sessions will be held three days a week, for eight weeks. Each session will consist of a 10-minute warm-up part, 45 minutes of the main part (aerobic and strength-resistance exercise), and five minutes of cooling down.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapeutic exercise program combined with RMT
For the RMT protocol, the Orygen-dual valve® device will be used. Each participant will start with a load of 30% of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Once every 10 days, the performance will be reviewed and the resistance will be increased by 10cmH2O of the initial MIP/MEP of each patient. Each session will consist of breathing through the device for 20 minutes (10 minutes dedicated to each muscle group). This process will be repeated once a day, five days a week, for eight weeks.
The therapeutic exercise program will be common to both groups and will be carried out at CHUAC hospital, in group sessions. The sessions will be held three days a week, for eight weeks. Each session will consist of a 10-minute warm-up part, 45 minutes of the main part (aerobic and strength-resistance exercise), and five minutes of cooling down.
Intervention Type
DEVICE
Therapeutic exercise program combined with sham RMT
The sham RMT protocol will have the same frequency as in the intervention group. The therapeutic exercise program will be common to both groups and will be carried out at CHUAC hospital, in group sessions. The sessions will be held three days a week, for eight weeks. Each session will consist of a 10-minute warm-up part, 45 minutes of the main part (aerobic and strength-resistance exercise), and five minutes of cooling down.
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Those diagnosed with a first stroke occurring three to six months after the onset (subacute phase).
* Those aged 18 years or older.
* Those able to walk at least 10 meters, with or without walking aids and/or physical assistance from another person.
* Those aged 18 years or older.
* Those able to walk at least 10 meters, with or without walking aids and/or physical assistance from another person.
Exclusion Criteria
* Those with recurrent stroke.
* Those with a history of chronic respiratory disease.
* Those with other underlying neurological diseases with impaired functionality prior to the stroke.
* Those with other cardiovascular or metabolic diseases in an unstable phase.
* Those with severe cognitive deficits that impede understanding of the assessment tests and/or the intervention.
* Those with severe facial paralysis that impedes proper performance of pulmonary function and respiratory muscle strength tests.
* Those with a prior participation in a RMT program.
* Those who participate in a cardiovascular and/or strength-endurance training program at the time of the study.
* Those with any of the contraindications to performing the tests included in the study protocol: spirometry, respiratory muscle strength and endurance tests, and 6MWT.
* Those with any of the contraindications to physical exercise.
* Those with a history of chronic respiratory disease.
* Those with other underlying neurological diseases with impaired functionality prior to the stroke.
* Those with other cardiovascular or metabolic diseases in an unstable phase.
* Those with severe cognitive deficits that impede understanding of the assessment tests and/or the intervention.
* Those with severe facial paralysis that impedes proper performance of pulmonary function and respiratory muscle strength tests.
* Those with a prior participation in a RMT program.
* Those who participate in a cardiovascular and/or strength-endurance training program at the time of the study.
* Those with any of the contraindications to performing the tests included in the study protocol: spirometry, respiratory muscle strength and endurance tests, and 6MWT.
* Those with any of the contraindications to physical exercise.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Complexo Hospitalario Universitario de A Coruña
OTHER
Sponsor Role
collaborator
Universidade da Coruña
OTHER
Sponsor Role
collaborator
Ana Lista Paz
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ana Lista Paz
PhD. Permanent Labor Professor of the Faculty of Physiotherapy at the University of Coruña
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ana Lista Paz, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Physiotherapy, University of A Coruña.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of A Coruña (CHUAC)
A Coruña, , Spain
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Spain
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
Reference Type
BACKGROUND
Fulk GD, Ludwig M, Dunning K, Golden S, Boyne P, West T. How much change in the stroke impact scale-16 is important to people who have experienced a stroke? Top Stroke Rehabil. 2010 Nov-Dec;17(6):477-83. doi: 10.1310/tsr1706-477.
Reference Type
BACKGROUND
Chou CY, Ou YC, Chiang TR. Psychometric comparisons of four disease-specific health-related quality of life measures for stroke survivors. Clin Rehabil. 2015 Aug;29(8):816-29. doi: 10.1177/0269215514555137. Epub 2014 Oct 28.
Reference Type
BACKGROUND
Duncan PW, Lai SM, Bode RK, Perera S, DeRosa J. Stroke Impact Scale-16: A brief assessment of physical function. Neurology. 2003 Jan 28;60(2):291-6. doi: 10.1212/01.wnl.0000041493.65665.d6.
Reference Type
BACKGROUND
Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
Reference Type
BACKGROUND
Kendrick KR, Baxi SC, Smith RM. Usefulness of the modified 0-10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma. J Emerg Nurs. 2000 Jun;26(3):216-22. doi: 10.1016/s0099-1767(00)90093-x.
Reference Type
BACKGROUND
Sunjaya A, Poulos L, Reddel H, Jenkins C. Qualitative validation of the modified Medical Research Council (mMRC) dyspnoea scale as a patient-reported measure of breathlessness severity. Respir Med. 2022 Nov;203:106984. doi: 10.1016/j.rmed.2022.106984. Epub 2022 Sep 9.
Reference Type
BACKGROUND
Adams HP Jr, Davis PH, Leira EC, Chang KC, Bendixen BH, Clarke WR, Woolson RF, Hansen MD. Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Neurology. 1999 Jul 13;53(1):126-31. doi: 10.1212/wnl.53.1.126.
Reference Type
BACKGROUND
Lee Y, Kim G, Kwon S. The Usefulness of Auditory Perceptual Assessment and Acoustic Analysis for Classifying the Voice Severity. J Voice. 2020 Nov;34(6):884-893. doi: 10.1016/j.jvoice.2019.04.013. Epub 2019 May 17.
Reference Type
BACKGROUND
Chandrashekaraiah B, N S, K PT. Impact of Effortful Swallow with Progressive Resistance on Swallow Safety, Efficiency and Quality of Life in Individuals with Post-Stroke Dysphagia: Analysis Using DIGEST- FEES and SWAL-QOL. Indian J Otolaryngol Head Neck Surg. 2023 Dec;75(4):2836-2841. doi: 10.1007/s12070-023-03846-7. Epub 2023 May 17.
Reference Type
BACKGROUND
Trapl M, Enderle P, Nowotny M, Teuschl Y, Matz K, Dachenhausen A, Brainin M. Dysphagia bedside screening for acute-stroke patients: the Gugging Swallowing Screen. Stroke. 2007 Nov;38(11):2948-52. doi: 10.1161/STROKEAHA.107.483933. Epub 2007 Sep 20.
Reference Type
BACKGROUND
Bhakta NR, McGowan A, Ramsey KA, Borg B, Kivastik J, Knight SL, Sylvester K, Burgos F, Swenson ER, McCarthy K, Cooper BG, Garcia-Rio F, Skloot G, McCormack M, Mottram C, Irvin CG, Steenbruggen I, Coates AL, Kaminsky DA. European Respiratory Society/American Thoracic Society technical statement: standardisation of the measurement of lung volumes, 2023 update. Eur Respir J. 2023 Oct 12;62(4):2201519. doi: 10.1183/13993003.01519-2022. Print 2023 Oct.
Reference Type
BACKGROUND
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
Reference Type
BACKGROUND
Kollen B, Kwakkel G, Lindeman E. Time dependency of walking classification in stroke. Phys Ther. 2006 May;86(5):618-25.
Reference Type
BACKGROUND
Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
Reference Type
BACKGROUND
Mehrholz J, Pohl M, Kugler J, Elsner B. The Improvement of Walking Ability Following Stroke. Dtsch Arztebl Int. 2018 Sep 28;115(39):639-645. doi: 10.3238/arztebl.2018.0639.
Reference Type
BACKGROUND
Ward I, Pivko S, Brooks G, Parkin K. Validity of the stroke rehabilitation assessment of movement scale in acute rehabilitation: a comparison with the functional independence measure and stroke impact scale-16. PM R. 2011 Nov;3(11):1013-21. doi: 10.1016/j.pmrj.2011.08.537.
Reference Type
BACKGROUND
Salter K, Jutai J, Foley N, Teasell R. Clinical Outcome Variables Scale: A retrospective validation study in patients after stroke. J Rehabil Med. 2010 Jul;42(7):609-13. doi: 10.2340/16501977-0567.
Reference Type
BACKGROUND
Inouye M, Hashimoto H, Mio T, Sumino K. Influence of admission functional status on functional change after stroke rehabilitation. Am J Phys Med Rehabil. 2001 Feb;80(2):121-5; quiz 126, 146. doi: 10.1097/00002060-200102000-00008.
Reference Type
BACKGROUND
Hsueh IP, Lin JH, Jeng JS, Hsieh CL. Comparison of the psychometric characteristics of the functional independence measure, 5 item Barthel index, and 10 item Barthel index in patients with stroke. J Neurol Neurosurg Psychiatry. 2002 Aug;73(2):188-90. doi: 10.1136/jnnp.73.2.188.
Reference Type
BACKGROUND
Denti L, Agosti M, Franceschini M. Outcome predictors of rehabilitation for first stroke in the elderly. Eur J Phys Rehabil Med. 2008 Mar;44(1):3-11.
Reference Type
BACKGROUND
Brock KA, Goldie PA, Greenwood KM. Evaluating the effectiveness of stroke rehabilitation: choosing a discriminative measure. Arch Phys Med Rehabil. 2002 Jan;83(1):92-9. doi: 10.1053/apmr.2002.27348.
Reference Type
BACKGROUND
Beninato M, Gill-Body KM, Salles S, Stark PC, Black-Schaffer RM, Stein J. Determination of the minimal clinically important difference in the FIM instrument in patients with stroke. Arch Phys Med Rehabil. 2006 Jan;87(1):32-9. doi: 10.1016/j.apmr.2005.08.130.
Reference Type
BACKGROUND
Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.
Reference Type
BACKGROUND
Beninato M, Portney LG, Sullivan PE. Using the International Classification of Functioning, Disability and Health as a framework to examine the association between falls and clinical assessment tools in people with stroke. Phys Ther. 2009 Aug;89(8):816-25. doi: 10.2522/ptj.20080160. Epub 2009 Jun 11.
Reference Type
BACKGROUND
Wee JY, Wong H, Palepu A. Validation of the Berg Balance Scale as a predictor of length of stay and discharge destination in stroke rehabilitation. Arch Phys Med Rehabil. 2003 May;84(5):731-5. doi: 10.1016/s0003-9993(02)04940-7.
Reference Type
BACKGROUND
Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.
Reference Type
BACKGROUND
Knorr S, Brouwer B, Garland SJ. Validity of the Community Balance and Mobility Scale in community-dwelling persons after stroke. Arch Phys Med Rehabil. 2010 Jun;91(6):890-6. doi: 10.1016/j.apmr.2010.02.010.
Reference Type
BACKGROUND
Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
Reference Type
BACKGROUND
Andersson AG, Kamwendo K, Seiger A, Appelros P. How to identify potential fallers in a stroke unit: validity indexes of 4 test methods. J Rehabil Med. 2006 May;38(3):186-91. doi: 10.1080/16501970500478023.
Reference Type
BACKGROUND
Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. doi: 10.1136/jnnp.53.7.576.
Reference Type
BACKGROUND
Thilarajah S, Mentiplay BF, Bower KJ, Tan D, Pua YH, Williams G, Koh G, Clark RA. Factors Associated With Post-Stroke Physical Activity: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Sep;99(9):1876-1889. doi: 10.1016/j.apmr.2017.09.117. Epub 2017 Oct 19.
Reference Type
BACKGROUND
Lee J, Stone AJ. Combined Aerobic and Resistance Training for Cardiorespiratory Fitness, Muscle Strength, and Walking Capacity after Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104498. doi: 10.1016/j.jstrokecerebrovasdis.2019.104498. Epub 2019 Nov 13.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Macchiavelli A, Giffone A, Ferrarello F, Paci M. Reliability of the six-minute walk test in individuals with stroke: systematic review and meta-analysis. Neurol Sci. 2021 Jan;42(1):81-87. doi: 10.1007/s10072-020-04829-0. Epub 2020 Oct 16.
Reference Type
BACKGROUND
Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
Reference Type
BACKGROUND
Hendrey G, Holland AE, Mentiplay BF, Clark RA, Williams G. Do Trials of Resistance Training to Improve Mobility After Stroke Adhere to the American College of Sports Medicine Guidelines? A Systematic Review. Arch Phys Med Rehabil. 2018 Mar;99(3):584-597.e13. doi: 10.1016/j.apmr.2017.06.021. Epub 2017 Jul 26.
Reference Type
BACKGROUND
Eng JJ. Fitness and Mobility Exercise (FAME) Program for stroke. Top Geriatr Rehabil. 2010;26(4):310-323. doi: 10.1097/TGR.0b013e3181fee736.
Reference Type
BACKGROUND
MacKay-Lyons M, Billinger SA, Eng JJ, Dromerick A, Giacomantonio N, Hafer-Macko C, Macko R, Nguyen E, Prior P, Suskin N, Tang A, Thornton M, Unsworth K. Aerobic Exercise Recommendations to Optimize Best Practices in Care After Stroke: AEROBICS 2019 Update. Phys Ther. 2020 Jan 23;100(1):149-156. doi: 10.1093/ptj/pzz153.
Reference Type
BACKGROUND
Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
Reference Type
BACKGROUND
Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish.
Reference Type
BACKGROUND
Parreiras de Menezes KK, Nascimento LR, Ada L, Avelino PR, Polese JC, Mota Alvarenga MT, Barbosa MH, Teixeira-Salmela LF. High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):205-212. doi: 10.1016/j.apmr.2018.09.115. Epub 2018 Oct 12.
Reference Type
BACKGROUND
Gomes-Neto M, Saquetto MB, Silva CM, Carvalho VO, Ribeiro N, Conceicao CS. Effects of Respiratory Muscle Training on Respiratory Function, Respiratory Muscle Strength, and Exercise Tolerance in Patients Poststroke: A Systematic Review With Meta-Analysis. Arch Phys Med Rehabil. 2016 Nov;97(11):1994-2001. doi: 10.1016/j.apmr.2016.04.018. Epub 2016 May 20.
Reference Type
BACKGROUND
Fabero-Garrido R, Del Corral T, Angulo-Diaz-Parreno S, Plaza-Manzano G, Martin-Casas P, Cleland JA, Fernandez-de-Las-Penas C, Lopez-de-Uralde-Villanueva I. Respiratory muscle training improves exercise tolerance and respiratory muscle function/structure post-stroke at short term: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2022 Sep;65(5):101596. doi: 10.1016/j.rehab.2021.101596. Epub 2021 Nov 18.
Reference Type
BACKGROUND
Clague-Baker N, Robinson T, Hagenberg A, Drewry S, Gillies C, Singh S. The validity and reliability of the Incremental Shuttle Walk Test and Six-minute Walk Test compared to an Incremental Cycle Test for people who have had a mild-to-moderate stroke. Physiotherapy. 2019 Jun;105(2):275-282. doi: 10.1016/j.physio.2018.12.005. Epub 2018 Dec 21.
Reference Type
BACKGROUND
Fulk GD, He Y. Minimal Clinically Important Difference of the 6-Minute Walk Test in People With Stroke. J Neurol Phys Ther. 2018 Oct;42(4):235-240. doi: 10.1097/NPT.0000000000000236.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025/061
Identifier Type: OTHER
Identifier Source: secondary_id
REMUST
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke
NCT01712724
COMPLETED
NA
Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program
NCT02779036
COMPLETED
NA
Evaluation of Whether Functional Strength Training Can Enhance Motor Recovery of the Upper Limb After Stroke
NCT00360789
COMPLETED
PHASE1/PHASE2
Effect of Mirror Therapy and Task Oriented Training for Persons With Paretic Upper Extremity
NCT02917343
COMPLETED
NA
Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke
NCT03171012
RECRUITING
NA
Stepper Aerobic Training on Fitness, Disability, Inflammation and Thrombosis in Stroke Patients
NCT02923765
COMPLETED
NA
Thera-band Resisted Treadmill Training for Chronic Stroke Patients
NCT04974840
UNKNOWN
NA
Forced Aerobic Exercise for Stroke Rehabilitation
NCT02494518
COMPLETED
NA
Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke.
NCT06571292
COMPLETED
NA
Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke
NCT05820815
RECRUITING
NA
Effects of Aerobic Training Post-stroke
NCT02798237
COMPLETED
PHASE4
Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
NCT02543450
COMPLETED
NA
Strength Training and Stroke
NCT00629005
COMPLETED
PHASE1/PHASE2
Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
NCT06933147
COMPLETED
NA
Effects of Early Exercise in Patients With Moderate to Severe Stroke.
NCT04241952
COMPLETED
NA
Effect of Rhythmic Upper-limb Training in Stroke Patients
NCT02139553
COMPLETED
NA
Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients
NCT02889146
COMPLETED
NA
Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
NCT03819764
COMPLETED
NA
Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
NCT04737395
UNKNOWN
NA
Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients
NCT03497650
COMPLETED
NA
The Efficacy of Additional Motor Training Dosage During the Early Stages Post Stroke on the Upper Extremity Recovery
NCT07056049
RECRUITING
NA
Effects of Two Different Kinds of Exercise on Stroke Rehabilitation
NCT00108680
COMPLETED
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.
NCT05945212
RECRUITING
NA
Aerobic Exercise in Early Subacute Stroke
NCT02107768
COMPLETED
NA