Unique ID issued by UMIN | UMIN000043312 |
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Receipt number | R000048440 |
Scientific Title | Effects of ACuTe phase IntensiVE Physical Activity Monitoring and education for patients with cardiovascular disease: A prospective, randomised, parallel-group, outcome blinded, controlled, factorial, pilot study. |
Date of disclosure of the study information | 2021/02/12 |
Last modified on | 2022/02/13 14:55:57 |
Effects of ACuTe phase IntensiVE Physical Activity Monitoring and education
for patients with cardiovascular disease:
A prospective, randomised, parallel-group, outcome blinded, controlled, factorial, pilot study.
ACTIVE PA-Monitoring pilot trial
Effects of ACuTe phase IntensiVE Physical Activity Monitoring and education
for patients with cardiovascular disease:
A prospective, randomised, parallel-group, outcome blinded, controlled, factorial, pilot study.
ACTIVE PA-Monitoring pilot trial
Japan |
Inpatients with cardiovascular disease
Cardiology | Rehabilitation medicine |
Others
NO
To examine the usefulness of patient education using physical activity monitoring devices for patients with cardiovascular disease during hospitalization.
Efficacy
Mean physical activity during hospitalization
Change in lower extremity function from baseline to discharge (gait speed, SPPB)
Change in physical activity from baseline to discharge
Six-minute walk distance at discharge
Health-related QOL at discharge (KCCQ-12, SF-36 physical function)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
YES
Central registration
2
Treatment
Maneuver |
1) Usual Care
2) Physical activity education using multi-person physical activity monitor
1) Usual Care
18 | years-old | <= |
Not applicable |
Male and Female
1) Patients hospitalized for cardiovascular disease
2) Aged 18 years or older
Significant myocardial ischemia during low-intensity exercise
Acute infective endocarditis, myocarditis, and pericaritis
Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy
Severe pulmonary hypertension
Intracardiac thrombus
Untreated life-threatening arrhythmia
Patients with circulatory assist device
History of aortic dissection, or presence of aortic aneurysm or aortic dissection
Patients with uncontrolled diabetes
Peripheral arterial disease (Fontain 3-4)
Recent embolism
Patients undergoing hemodialysis
Patients who needed assistance for walking a month before hospitalization
Dementia
Pregnant, lactational woman, patients may be pregnant
46
1st name | Kentaro |
Middle name | |
Last name | Kamiya |
Kitasato University
Department of Rehabilitation, School of Allied Health Sciences
252-0373
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
0427788111
k-kamiya@kitasato-u.ac.jp
1st name | Kentaro |
Middle name | |
Last name | Kamiya |
Kitasato University
Department of Rehabilitation, School of Allied Health Sciences
252-0373
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
0427788111
k-kamiya@kitasato-u.ac.jp
Kitasato University
The Ministry of Education, Culture, Sports, Science, and Technology (MEXT) of Japan.
Japanese Governmental office
Kitasato University Medical Ethics Organization(KMEO)
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
0427788111
rinri@med.kitasato-u.ac.jp
NO
北里大学病院(神奈川県)
2021 | Year | 02 | Month | 12 | Day |
Unpublished
No longer recruiting
2020 | Year | 03 | Month | 30 | Day |
2021 | Year | 02 | Month | 18 | Day |
2021 | Year | 02 | Month | 22 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 02 | Month | 12 | Day |
2022 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048440
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