UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048525 |
|---|---|
| Receipt number | R000055291 |
| Scientific Title | Factorial analysis of heart rate variability components synchronised with locomotor rhythm in patients with cardiovascular disease. |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2026/02/08 10:53:58 |
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Basic information
Public title
Factorial analysis of heart rate variability components synchronised with locomotor rhythm in patients with cardiovascular disease.
Acronym
Factorial analysis of heart rate variability components synchronised with locomotor rhythm in patients with cardiovascular disease.
Scientific Title
Factorial analysis of heart rate variability components synchronised with locomotor rhythm in patients with cardiovascular disease.
Scientific Title:Acronym
Factorial analysis of heart rate variability components synchronised with locomotor rhythm in patients with cardiovascular disease.
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyse and identify the factors responsible for the heart rate variability component that is synchronised with the locomotor rhythm, which has so far been regarded as noise, in patients with cardiovascular disease. Heart rate fluctuates under the influence of various factors and is also affected by the rhythm of exercise. We have studied the variability of heart rate rhythm during exercise and have reported that heart rate rhythm is influenced and drawn in by the rhythm of gait and that the strength of the influence from the exercise rhythm is related to exercise tolerance and age. In this study, data will be collected in patients with impaired circulatory function with the aim of identifying factors contributing to heart rate rhythm fluctuations synchronised with exercise rhythms for use in the assessment of exercise and cardiovascular function.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular ejection fraction, heart failure stage, heart rate variability component during exercise
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with cardiovascular disease who requested cardiopulmonary exercise testing
Key exclusion criteria
Patients with atrial fibrillation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita, Department of Physical Therapy
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba 286-8686 JAPAN
TEL
0476-20-7751
shinta.t@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita, Department of Physical Therapy
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba 286-8686 JAPAN
TEL
0476-20-7751
Homepage URL
shinta.t@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3 Kozunomori, Narita City, Chiba 286-8686 JAPAN
Tel
0476-20-7708
rinri_md@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国際医療福祉大学成田病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/file/KAKENHI-PROJECT-21K17535/21K17535seika.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/file/KAKENHI-PROJECT-21K17535/21K17535seika.pdf
Number of participants that the trial has enrolled
144
Results
After applying exclusion criteria to 144 cardiac patients, 17 post-AMI and 7 post-acute HF patients were analyzed. CLFC power at AT and exercise capacity showed no group differences. CLFC power at Peak was significantly higher in the AMI group (p<0.05), and the slope of CLFC power from AT to Peak was also significantly greater in the AMI group (p<0.05). These results suggest that myocardial mechanical properties and parasympathetic activity influence CLFC generation.
Results date posted
| 2026 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From cardiopulmonary exercise testing data of 144 cardiac patients, those with missing heart rate data, atrial fibrillation, or heart rate below 100 bpm at anaerobic threshold (AT) were excluded. A total of 24 patients in two disease groups with sufficient sample sizes for inferential statistics were analyzed: 17 patients with coronary artery disease after acute myocardial infarction (AMI group) and 7 patients with heart failure after acute exacerbation of chronic heart failure (HF group). No significant differences were observed between groups in CLFC power at AT or exercise capacity indices.
Participant flow
Data were collected from 144 cardiac patients who underwent cardiopulmonary exercise testing during the study period. Patients were excluded based on the following criteria: (1) missing heart rate data, (2) presence of atrial fibrillation, and (3) heart rate below 100 bpm at the anaerobic threshold (AT). Additionally, disease groups with insufficient sample sizes for inferential statistics were excluded. As a result, 24 patients were included in the final analysis: 17 patients with coronary artery disease after acute myocardial infarction (AMI group) and 7 patients with heart failure after acute exacerbation of chronic heart failure (HF group). All 24 patients completed the analysis with no dropouts.
Adverse events
This was a retrospective observational study analyzing existing data from previously conducted cardiopulmonary exercise testing. No additional intervention was performed on participants as part of this study. Therefore, no adverse events attributable to this study occurred.
Outcome measures
[Primary outcome measures]
Normalized power of the Cardio-Locomotor Frequency Component (CLFC power), specifically:
(1) CLFC power at anaerobic threshold (AT)
(2) CLFC power at peak exercise (Peak)
(3) Slope of CLFC power change from AT to Peak (calculated by linear regression using the least squares method)
[Secondary outcome measures]
Exercise capacity indices (oxygen uptake at AT and Peak, etc.)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
(1) Study design.
Collaborative, cross-sectional and observational study of International University of Health and Welfare and International University of Health and Welfare Narita Hospital
(2) Evaluation items and methods
(1) Primary endpoints
Left ventricular ejection fraction, heart failure stage, heart rate variability component during exercise
(2) Secondary endpoints
Skeletal muscle pump function, autonomic nerve activity, maximal oxygen uptake, anaerobic metabolic threshold
(3) Statistical analysis methods
Subjects were divided into two groups according to heart failure type, and the exercise heart rate variability component, skeletal muscle pump function and autonomic function were compared using an unpaired t-test. The significance level is set at a risk rate of less than 5%.
(4) Observation and examination items (samples and information to be used) and methods
The following items will be observed and examined
1) Basic subject information (age, sex, height, weight, diagnosis, medical history, treatment history and medication status): obtained from medical records.
2) Echocardiography results (left ventricular ejection fraction): obtained from medical records.
3) Cardiopulmonary exercise stress test (heart rate variability component during exercise, anaerobic metabolic threshold, maximum oxygen uptake): analysed by 12-lead ECG and expiratory gas analyser. ECG data are converted to R-R intervals and analysed for heart rate variability using the maximum entropy method with analysis software (MEMCALC). Components that match the exercise frequency are extracted as heart rate variability components during exercise.
4) Skeletal muscle pump function (single leg venous output is extracted using air plethysmography).
Management information
Registered date
| 2022 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055291
