UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050040 |
|---|---|
| Receipt number | R000056973 |
| Scientific Title | The effect of resistance training on autonomic nervous system in female university students |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/01/14 19:45:03 |
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Basic information
Public title
The effect of resistance training on autonomic nervous system in female university students
Acronym
The effect of resistance training on autonomic nervous system in female university students
Scientific Title
The effect of resistance training on autonomic nervous system in female university students
Scientific Title:Acronym
The effect of resistance training on autonomic nervous system in female university students
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Although advancement in breast cancer treatment and early detection have improved survival rates, about 33% of breast cancer patients report feeling fatigued until 10 years later. In clinical practice, many cancer patients are advised to limit physical activity to conserve energy expenditure and only provide exercise for shoulder range of motion. This causes deconditioning, and fatigue is exacerbated by the effects of cancer cachexia. Exercise therapy has been found to be useful in reducing cancer-related fatigue, but exercise prescriptions are unclear. Therefore, we believe that exercise programs should be designed that can reduce fatigue in cancer patients. It is said that fatigue is reduced by reducing inflammation after exercise, but we would like to verify the usefulness of exercise by a non-invasive method that does not burden the patient, and we think that the degree of inflammation can be estimated by looking at the change in the autonomic nervous activity of the heart called heart rate variability and the relationship with the reduction of fatigue. In the study so far, there are limitations that have not been sufficiently studied on changes in heart rate variability and reduction of fatigue after resistance exercise in breast cancer patients due to the lack of exercise prescriptions. Hence,
(1) Female university students enrolled in International University of Health and Welfare and Narita Japanese School
(2) After performing moderate-intensity resistance exercises suitable for breast cancer patients, autonomic nervous activity was quantified by heart rate variability measured
(3) By improving the regulatory function of autonomic nervous activity
(4) Clarifying the effectiveness of exercise programs
(5) We would like to design an exercise program that can reduce cancer-related fatigue and apply it to breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Heart Rat Variability(Before,After,30mins later)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
*Protocol
0-10mins: Heart rate variability
5mins: Warm up
25~35mins: Resistance training
5mins: Cool down
30mins: Heart rate variaility
Frequency: 10RMx3sets
Intensity: Rating of Perceives Exertion(RPE)7/10
Type: Squat, Bandd side steps, Forward lean lunges, Lunges, Bent row over, Shoulder abduction, Bicrps curl, Banded pull apart
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
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
-Students from International University of Health and Welfare and Narita Japanese Language School
-Students who are able to obtain written consent from the individual to participate in research of their own free will
-Age:20-35years old
-Female
-Body mass index(BMI):18.0-25.0kg/m2
-Not performing resistance training twice a week according to American College of Sports Medicine(ACSM)
Key exclusion criteria
-Consumption of alcohol or caffeine within 24hours prior to the study
-Have a history of hypertension, cardiac disease, or respiratory disease and so on that affects the autonomic nervous system
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nishida |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, Health Science at Narita
Zip code
286-8686
Address
4-3, Kozunomori Narita-Shi, Chiba-ken
TEL
0476-20-7701
yuusuken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ming Chieh |
| Middle name | |
| Last name | Tsai |
Organization
International University of Health and Welfare Narita Hospital
Division name
Physical Therapist, Department of Rehabilitation
Zip code
286-0124
Address
852 Hatakeda Narita, Chiba Prefecture
TEL
0476-35-5576
Homepage URL
22s1100@g.iuhw.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 Chiba Area
Address
852 Hatakeda Narita, Chiba Prefecture
Tel
0476-35-5613
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056973
