Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02923765 |
| Other study ID # |
201601026B0 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2017 |
| Est. completion date |
September 30, 2020 |
Study information
| Verified date |
February 2020 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
