UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057326 |
|---|---|
| Receipt number | R000065526 |
| Scientific Title | The impact of physical activity during or outside of working hours on cardiac and renal function in patients with heart disease who have returned to work |
| Date of disclosure of the study information | 2025/03/18 |
| Last modified on | 2025/09/05 09:53:18 |
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Basic information
Public title
The impact of physical activity during or outside of working hours on cardiac and renal function in patients with heart disease who have returned to work
Acronym
The impact of physical activity during or outside working hours on cardiac and renal function in patients with heart disease
Scientific Title
The impact of physical activity during or outside of working hours on cardiac and renal function in patients with heart disease who have returned to work
Scientific Title:Acronym
The impact of physical activity during or outside working hours on cardiac and renal function in patients with heart disease
Region
| Japan |
Condition
Condition
Heart failure and acute coronary syndrome
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the impact of physical activity during working hours and non-working hours on renal function in patients with heart disease who have returned to work. In addition, a secondary purpose is to clarify the impact of physical activity during working hours and non-working hours on other blood biochemical data, including cardiac function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated glomerular filtration rate calculated from serum cystatin C (eGFRcys)
Key secondary outcomes
1) Estimated glomerular filtration rate calculated from serum creatinine (eGFRcreat)
2) Urine protein/creatinine ratio
3) Other blood biochemistry data (BNP, urea nitrogen, albumin, triglycerides (TG), HDL cholesterol, LDL cholesterol, hemoglobin, blood glucose)
4) Incidence of adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were at least 18 years old when they gave their consent
2) Patients with heart failure or acute coronary syndrome who received inpatient treatment and cardiac rehabilitation
3) Patients who plan to return to work within one month of being discharged (if they change their employment status or job content, etc., but still work, this is also defined as returning to work)
4) Patients who consented to participate in this study
Key exclusion criteria
1) Patients who are not independent in their daily living.
2) Patients with unstable angina pectoris.
3) Patients with arrhythmia that is poorly controlled and causes hemodynamic abnormalities.
4) Patients with severe valvular disease.
5) Patients with uncontrolled diabetes.
6) Patients with other diseases that contraindicate exercise therapy.
7) Patients on dialysis.
8) Patients with other acute diseases or who are indicated for new acute phase treatment.
9) Patients with dementia.
10) Patients who will have difficulty attending regular outpatient appointments at the research facility after being discharged from hospital
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Toshimi |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5547
satot-pt@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5547
Homepage URL
satot-pt@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
024-547-1825
rs@fmu.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
太田西ノ内病院（福島県）、大原綜合病院（福島県）、総合南東北病院（福島県）、日本赤十字社医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is a prospective study with a three-month observation period. The items surveyed are as follows
Basic characteristics [sex, age, drinking history, smoking history, echocardiography findings, medical history, comorbidities, number of hospitalizations, etc.], physical condition (height, weight, BMI, blood pressure, pulse), physical function assessment [cardiopulmonary exercise test, grip strength], blood and urine tests, physical activity assessment (activity meter and questionnaire), sleep assessment, employment information, medication information, adverse events.
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065526
