UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034121
Receipt number R000033251
Scientific Title Development of the vascular rehabilitation method based on the vascular endthelial function mesurement
Date of disclosure of the study information 2018/09/14
Last modified on 2024/03/18 09:33:25

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Basic information

Public title

Development of the vascular rehabilitation method based on the vascular endthelial function mesurement

Acronym

Development of the vascular rehabilitation method

Scientific Title

Development of the vascular rehabilitation method based on the vascular endthelial function mesurement

Scientific Title:Acronym

Development of the vascular rehabilitation method

Region

Japan


Condition

Condition

patients of life style related diseases or pre-life style related diseases

Classification by specialty

Medicine in general Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aim to investigate the most effective exercise method for the vascular endothelium function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

vascular endothelium function

Key secondary outcomes

Various biochemical profiles


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

low intensity exercise of hand grip training

Interventions/Control_2

moderate intensity exercise of hand grip training

Interventions/Control_3

high intensity exercise of hand grip training

Interventions/Control_4

the aerobic exercise level of walking

Interventions/Control_5

sedentary

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects over the age of 20 years with pre and post life style related disease
2. Subjects able to provide written informed consent for study participation

Key exclusion criteria

1. Patients presenting with unstable angina, acute phase acute coronary syndrome
2. Other patients deemed by a physician to be otherwise unsuitable for participation in this study
3. Subjects over the age of 90 years

Target sample size

65


Research contact person

Name of lead principal investigator

1st name Misa
Middle name
Last name Miura

Organization

Tsukuba University of Technology

Division name

Faculty of health science

Zip code

305-8521

Address

4-12-7 Kasuga, Tsukuba City

TEL

029-858-9552

Email

m.miura@k.tsukuba-tech.ac.jp


Public contact

Name of contact person

1st name Misa
Middle name
Last name Miura

Organization

Tsukuba University of Technology

Division name

Faculty of health science

Zip code

305-8521

Address

4-12-7 Kasuga, Tsukuba City

TEL

029-858-9552

Homepage URL


Email

m.miura@k.tsukuba-tech.ac.jp


Sponsor or person

Institute

Tsukuba University of Technology

Institute

Department

Personal name



Funding Source

Organization

Tsukuba University of Technology

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tsukuba University of Technology

Address

4-12-7 Kasuga, Tsukuba City

Tel

029-858-9552

Email

m.miura@k.tsukuba-tech.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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

file:///C:/Users/MIURA%20MISA/Downloads/364.pdf

Number of participants that the trial has enrolled

15

Results

No adverse events were observed due to HG exercise, and all patients were able to exercise during the study period. No significant changes in muscle strength were observed within the implementation period. There was no significant difference in vascular endothelial function; In the HD group, moderate-intensity exercise tended to improve compared to before low-intensity exercise, but high-intensity exercise tended to worsen.

Results date posted

2023 Year 09 Month 18 Day

Results Delayed

Delay expected

Results Delay Reason

Data collection is expected to be delayed due to information collection restrictions due to the spread of the new coronavirus infection.

Date of the first journal publication of results


Baseline Characteristics

The subjects of this study were HD patients who had been stably undergoing maintenance dialysis for more than 3 months due to end-stage renal disease (HD group: n = 7). Healthy subjects (n=8) were used as a control group. HD patients were defined as patients who had stable blood flow for at least 3 months using an intra-forearm shunt as a blood access. Exclusion criteria are unstable angina, pulmonary hypertension, acute myocardial infarction, decrease in resting SpO2 <90%, significant decline in cognitive function, and other conditions in which the physician is inappropriate to participate in this study based on medical grounds.

Participant flow

The subjects of this study were 186 HD patients at a single facility who had been stably receiving maintenance dialysis for more than 3 months due to end-stage renal disease, excluding 106 patients who met the exclusion criteria. The study began with 10 patients who consented to the study, and 7 patients completed the entire protocol, excluding 3 patients who were transferred to another hospital or dropped out at their own request. For the control group, 8 of the 10 healthy volunteers who had given their consent and who had applied through posters completed the entire protocol.

Adverse events

There were no adverse events caused by this study.

Outcome measures

The measurement items for this study included vascular endothelial function, arteriosclerosis measurement, grip strength, lower limb muscle strength, arteriosclerosis measurement, and various biochemical tests.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 09 Month 13 Day

Date of IRB

2017 Year 07 Month 27 Day

Anticipated trial start date

2018 Year 09 Month 13 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 05 Month 30 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 09 Month 13 Day

Last modified on

2024 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033251


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name