Ischemic StrokeNCT02923765
Stepper Aerobic Training on Fitness, Disability, Inflammation and Thrombosis in Stroke Patients
A study testing Aerobic training by a stepper in people with Ischemic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Stroke rehabilitation of hemiplegics primarily lies in motor control and training of activities of daily life. Whole body aerobics is much less emphasized. Nonetheless, cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy people, which is prone to deconditioning. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Aerobic training by a stepper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 30 Sep 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ischemic stroke
- Must be able to ride the stepper
- No cardiovascular disease in the healthy control group
Who cannot join
- Resting heart rate greater than 100 beats per minute
- Atrial fibrillation or flutter
- Poor control of high blood pressure or diabetes
- Patients with peripheral arterial occlusive disease
- Patients with end-stage renal disease
- Patients receiving anticoagulant therapy
- Neurological instability
- Confusion or cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Stepper Aerobic Training on Cardiopulmonary Fitness, Disability, Systemic Inflammation and Thrombosis in Stroke Patients With Hemiplegia
Stroke rehabilitation of hemiplegics primarily lies in motor control and training of activities of daily life. Whole body aerobics is much less emphasized. Nonetheless, cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy people, which is prone to deconditioning. The present study aims to understand the efficacy of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness, daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and randomized design. The subjects will be recruited from the hospitalized patients in the rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to stroke will be enrolled and randomized into two groups: combined training (CT) and usual rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks in total. A constant-power semi-recumbent stepper will be employed as the training modality. It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion. Additional 20 healthy participants will also be recruited as the healthy control. Assessment before and after training includes: (I) graded cardiopulmonary exercise test using constant-load stepper. (II) Functional Independence Measure. (III) coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen activator inhibitor-1, D-dimer, factor VIII, etc. [the 1st year]; (IV) monocyte-platelet aggregation and its subtypes, using flow cytometry [the 2nd year]. ( V) systemic inflammation, platelet activation and prognostic biomarker:C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc [the 3rd year]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA, etc. The investigation will start after approval and end in 2019, July. We hope this investigation will establish a more comprehensive rehabilitation program for clinical application.
Read the detailed description
In Taiwan, there are 220,00 stroke survivors and each year, 10,000 new suffers causing impairment in daily activities. This is the leading cause of disability and consumes 4.5 billions of National Health Insurance yearly. More than half of them become hemi-paretics and hemi-plegics. Stroke leads to the adverse combination of reduced functional capacity and increased energy demands to perform routine activities Thereby, physiologic fitness reserve is diminished. Aerobic fitness is low in stroke survivors. Among ambulatory patients suffering from hemiparetic stroke, the VO2peak is approximately half that of age-matched individuals , a level that is near the minimum range required for activities of daily life. It may limit their ability to perform everyday activities and cause further complications, such as cardiopulmonary de-conditioning, muscular atrophy, joint stiffness, or even learned nonuse.
Many patients are discharged from neurorehabilitation focusing on motor control and ADL (activity of daily life ) training, while aerobic fitness training is neglected, especially in non-ambulatory patients. Randomized exercise training studies using a wide variety of modalities and protocols have demonstrated an 8~23% improvement in VO2peak after 2-6 months of training . However, most research recruit patients with hemiparesis who have mild-to-moderate gait impairment . No specific training protocols has been adequately studied or can be suggested for hemiplegic patients. It is difficult for them to partake in aerobic exercise, like walking or biking. There is a need to develop a new aerobic exercise module suitable for the patients, especially for those with ambulation difficulty resulted from severe paralysis.
In the current investigation, a semi-recumbent stepper with constant power design will be adopted as training modality. It accommodates motor function deficits by providing trunk and distal limb support . In addition, semi- recumbent stepper uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion.
Aerobic fitness training has been proposed as a beneficial approach for people with stroke. Taking part in fitness training could have a range of other benefits important to people with stroke such as improving cognitive function, improving mood, and quality of life, and it could reduce the risk of recurrent stroke . In the present investigation, the outcome measurement will not only include cardiopulmonary fitness and the degree of daily activity dependency, but also prognostic biomarkers, thrombotic and inflammatory state.
It is well-documented that exercise training has an anti-thrombotic effect . Increased physical activity and cardiorespiratory fitness are associated with a reduced risk of fatality from cardiovascular diseases. Moreover, increased studies have demonstrated that regular moderate-intensity physical activity is associated with health benefits, even when aerobic fitness (e.g., maximal oxygen uptake, VO2max) remains unchanged . For sedentary persons at risk for cardiovascular disease, adopting a moderately active lifestyle can induce important health benefits, such as reducing prothrombotic factors and lipid peroxidation , increasing fibrinolytic activity and high-density lipoprotein levels , etc. One of the present investigation aims to understand whether 20~25 sessions of aerobic training at moderate intensity will induce these favorable adaptations that could contribute to decreased risk for ischemic event.
This is a prospective randomized controlled study. Eighty stroke sufferers with unilateral weakness will be enrolled in Chang Gung Memorial Hospital at Linkuo. They will be randomized into two groups: combined training (CT) and usual rehabilitation (UR). Participants in the CT group will receive supervised aerobic training at moderate intensity in addition to usual neuro-rehabilitation, in which motor control and task-oriented ADL training are the major contents. Patients in the UR will undergo usual neuro-rehabilitation only. The aim of the present research is to evaluate the efficacy of an aerobic training program at moderate intensity for a total of 20~25 sessions using a semi-recumbent stepper with constant power design. Pre- and post-training measurement includes (I) cardiopulmonary fitness, (II) daily activities dependency, (III) coagulation and fibrinolysis profile. [the 1st year] (IV) monocyte subsets and its interaction with platelets [the 2nd year]. (V) Systemic inflammation, platelet activation and prognostic biomarker:C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc. [the 3rd year]. Venous blood will be sampled two times before and after rehabilitation.
Hopefully, this clinical investigation will establish the model of incorporating aerobics in the hemiplegic patients following stroke, and its efficacy for clinical application.
- Conditions
- Ischemic Stroke
- Being tested
- Aerobic training by a stepper
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic training by a stepperOther
Aerobic training by a stepper: 35 minutes/session, 5 sessions/week and 4-5 weeks in total
| Study group | Role | What they receive |
|---|---|---|
| combined training (CT) | Active comparator | additional aerobic training by a stepper : 35 minutes/session, 5 sessions/week and 4-5 weeks Receives: Other: Aerobic training by a stepper |
| usual rehabilitation (UR) | No intervention | Usual rehabilitation, without additional aerobic training |
| healthy participant (HP) | No intervention | healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM)
CPET
Measured: three years
Secondary outcomes (3)
Thrombosis and Coagulation Activities of Blood Samples of All Participants by Flow Cytometry,
detection of monocytes and platelets aggregation
Measured: three years
Thrombosis and Coagulation Activities of Blood Samples of All Participants by Dynamic TG Assay
detection the amount and time of thrombin generation.
Measured: three years
Thrombosis and Coagulation Activities of Blood Samples of All Participants Enzyme-linked Immunosorbent Assay (ELISA)
ELISA
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Aug 2017
- Primary completion26 Feb 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Chun Huang, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923765
- Sponsor's protocol ID
- 201601026B0
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2016
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Stepper Aerobic Training on Cardiopulmonary Fitness, Disability, Systemic Inflammation and Thrombosis in Stroke Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT02923765
- Acronym / sponsor ID
- 201601026B0
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 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.
Stroke rehabilitation of hemiplegics primarily lies in motor control and training of activities of daily life. Whole body aerobics is much less emphasized. Nonetheless, cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy people, which is prone to deconditioning. The present study aims to understand the efficacy of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness, daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and randomized design. The subjects will be recruited from the hospitalized patients in the rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to stroke will be enrolled and randomized into two groups: combined training (CT) and usual rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks in total. A constant-power semi-recumbent stepper will be employed as the training modality. It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion. Additional 20 healthy participants will also be recruited as the healthy control. Assessment before and after training includes: (I) graded cardiopulmonary exercise test using constant-load stepper. (II) Functional Independence Measure. (III) coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen activator inhibitor-1, D-dimer, factor VIII, etc. [the 1st year]; (IV) monocyte-platelet aggregation and its subtypes, using flow cytometry [the 2nd year]. ( V) systemic inflammation, platelet activation and prognostic biomarker:C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc [the 3rd year]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA, etc. The investigation will start after approval and end in 2019, July. We hope this investigation will establish a more comprehensive rehabilitation program for clinical application.
Detailed description
In Taiwan, there are 220,00 stroke survivors and each year, 10,000 new suffers causing impairment in daily activities. This is the leading cause of disability and consumes 4.5 billions of National Health Insurance yearly. More than half of them become hemi-paretics and hemi-plegics. Stroke leads to the adverse combination of reduced functional capacity and increased energy demands to perform routine activities Thereby, physiologic fitness reserve is diminished. Aerobic fitness is low in stroke survivors. Among ambulatory patients suffering from hemiparetic stroke, the VO2peak is approximately half that of age-matched individuals , a level that is near the minimum range required for activities of daily life. It may limit their ability to perform everyday activities and cause further complications, such as cardiopulmonary de-conditioning, muscular atrophy, joint stiffness, or even learned nonuse.
Many patients are discharged from neurorehabilitation focusing on motor control and ADL (activity of daily life ) training, while aerobic fitness training is neglected, especially in non-ambulatory patients. Randomized exercise training studies using a wide variety of modalities and protocols have demonstrated an 8~23% improvement in VO2peak after 2-6 months of training . However, most research recruit patients with hemiparesis who have mild-to-moderate gait impairment . No specific training protocols has been adequately studied or can be suggested for hemiplegic patients. It is difficult for them to partake in aerobic exercise, like walking or biking. There is a need to develop a new aerobic exercise module suitable for the patients, especially for those with ambulation difficulty resulted from severe paralysis.
In the current investigation, a semi-recumbent stepper with constant power design will be adopted as training modality. It accommodates motor function deficits by providing trunk and distal limb support . In addition, semi- recumbent stepper uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion.
Aerobic fitness training has been proposed as a beneficial approach for people with stroke. Taking part in fitness training could have a range of other benefits important to people with stroke such as improving cognitive function, improving mood, and quality of life, and it could reduce the risk of recurrent stroke . In the present investigation, the outcome measurement will not only include cardiopulmonary fitness and the degree of daily activity dependency, but also prognostic biomarkers, thrombotic and inflammatory state.
It is well-documented that exercise training has an anti-thrombotic effect . Increased physical activity and cardiorespiratory fitness are associated with a reduced risk of fatality from cardiovascular diseases. Moreover, increased studies have demonstrated that regular moderate-intensity physical activity is associated with health benefits, even when aerobic fitness (e.g., maximal oxygen uptake, VO2max) remains unchanged . For sedentary persons at risk for cardiovascular disease, adopting a moderately active lifestyle can induce important health benefits, such as reducing prothrombotic factors and lipid peroxidation , increasing fibrinolytic activity and high-density lipoprotein levels , etc. One of the present investigation aims to understand whether 20~25 sessions of aerobic training at moderate intensity will induce these favorable adaptations that could contribute to decreased risk for ischemic event.
This is a prospective randomized controlled study. Eighty stroke sufferers with unilateral weakness will be enrolled in Chang Gung Memorial Hospital at Linkuo. They will be randomized into two groups: combined training (CT) and usual rehabilitation (UR). Participants in the CT group will receive supervised aerobic training at moderate intensity in addition to usual neuro-rehabilitation, in which motor control and task-oriented ADL training are the major contents. Patients in the UR will undergo usual neuro-rehabilitation only. The aim of the present research is to evaluate the efficacy of an aerobic training program at moderate intensity for a total of 20~25 sessions using a semi-recumbent stepper with constant power design. Pre- and post-training measurement includes (I) cardiopulmonary fitness, (II) daily activities dependency, (III) coagulation and fibrinolysis profile. [the 1st year] (IV) monocyte subsets and its interaction with platelets [the 2nd year]. (V) Systemic inflammation, platelet activation and prognostic biomarker:C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc. [the 3rd year]. Venous blood will be sampled two times before and after rehabilitation.
Hopefully, this clinical investigation will establish the model of incorporating aerobics in the hemiplegic patients following stroke, and its efficacy for clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined training (CT) | Active comparator | Other: Aerobic training by a stepperadditional aerobic training by a stepper : 35 minutes/session, 5 sessions/week and 4-5 weeks |
| usual rehabilitation (UR) | No intervention | –Usual rehabilitation, without additional aerobic training |
| healthy participant (HP) | No intervention | –healthy control |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of ischemic stroke
- Must be able to ride the stepper
- No cardiovascular disease in the healthy control group
Key exclusion criteria (8 listed)
- Resting heart rate greater than 100 beats per minute
- Atrial fibrillation or flutter
- Poor control of high blood pressure or diabetes
- Patients with peripheral arterial occlusive disease
- Patients with end-stage renal disease
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 |
|---|---|---|
| Aerobic training by a stepperAerobic training by a stepper: 35 minutes/session, 5 sessions/week and 4-5 weeks in total | Other | combined training (CT) |
Primary outcome
Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM)
Time frame: three years
CPET
3 secondary outcomes
Thrombosis and Coagulation Activities of Blood Samples of All Participants by Flow Cytometry,
Time frame: three years
Thrombosis and Coagulation Activities of Blood Samples of All Participants by Dynamic TG Assay
Time frame: three years
Thrombosis and Coagulation Activities of Blood Samples of All Participants Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: three years
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 29 Jul 2021.
- 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.
Shu-Chun Huang, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training by a stepper in people with Ischemic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 8 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 29 Jul 2021. 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 Taiwan. 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?
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?
Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM) (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.