UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052103 |
|---|---|
| Receipt number | R000059466 |
| Scientific Title | Effects of different training methods on the triceps muscles on lower leg muscle pump function. |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2023/09/04 16:19:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of different training methods on the triceps muscles on lower leg muscle pump function.
Acronym
Effects of different training methods on the triceps muscles on lower leg muscle pump function.
Scientific Title
Effects of different training methods on the triceps muscles on lower leg muscle pump function.
Scientific Title:Acronym
Effects of different training methods on the triceps muscles on lower leg muscle pump function.
Region
| Japan |
Condition
Condition
young healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Skeletal muscles increase venous return by storing blood in the veins during relaxation and mechanically compressing the veins during contraction, causing the blood in the veins to move toward the heart. This action is called the muscle pump, and is considered an important mechanism for maintaining exercise, since increased venous return during exercise leads to increased cardiac output. In particular, the leg muscle pump is considered important for maintaining standing movements such as walking, and is also called the second heart, because it functions at the furthest point from the heart. The function of the leg muscle pump is defined by the rate of increase in venous ejection fraction (Lower leg ejection fraction: LgEF) and venous flow velocity associated with leg muscle contraction, and has been reported to be related to the muscle mass and strength of the triceps femoris muscle. In clinical practice, calf raises (standing, weight-bearing heel raising exercises) are taught to increase triceps muscle strength in order to improve leg muscle pump function. However, it is not clear to what extent calf raises improve lower leg pump function. On the other hand, the optimal intensity and frequency of calf raises are also unknown. The above suggests that although the leg muscle pump function is an important mechanism for maintaining movements such as walking, the effectiveness of training to improve this function is unknown. The purpose of this study is to determine the effects of each of the clinically practiced calf raise training methods on leg muscle pump function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LgEF (lower leg ejection fraction)
Measure using an air plethysmograph (APG-1000). At first, the subject's leg is elevated about 45 to empty venous blood in the lower leg. Then, the subject is placed in a standing position, and venous capacity is measured by arterial inflow and venous regurgitation at rest, and the venous filling index is calculated. Next, LgEF is evaluated by performing a single toe-up exercise and measuring ejection fraction. The evaluation periods will be pre-intervention, mid-intervention (week 4), and 8 weeks post-intervention.
Key secondary outcomes
1. Ankle joint plantar flexion maximum torque
Ankle plantar flexion muscle force (Nm) and ankle plantar flexion muscle force/body weight ratio (%) by isometric contraction of the triceps femoris muscle are measured using a multi-purpose muscle function evaluation exercise device (BIODEX System 4).
2. Lower limb skeletal muscle mass
Measurements will be taken using a high-precision body component analyzer (Inbody). Subjects will be barefoot and will assume a static standing position on the device for about 1 minute. The bioelectrical impedance method measures the skeletal muscle mass of the left and right limbs and trunk, and the lower limb muscle mass is employed in the measurement.
3. Lower leg circumference
The Calf Ankle Index, which is considered to be an indicator of general condition and is not influenced by individual differences, is measured.
4. Lower leg capacity
Lower leg volume is measured using the water displacement method, one of the quantitative assessments of volumetric measurements. The subject immerses the lower leg in a tank full of water. The volume of the overflowing water is used to measure the leg volume.
All secondary outcomes will be assessed at the same time as the primary outcome.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Maximal load group: One-leg standing posture, weight-bearing, one-leg standing posture with the front of the foot on a 5-cm platform and the upper limb resting on a wall or other support to maintain balance. 1 sec for raising, 3 sec for lowering, and the maximum number of times measured prior to the intervention. After a break, the opposite side is also performed. This exercise is performed 3 days a week for 8 weeks.
Interventions/Control_2
Moderate load group: One-leg standing posture, weight-bearing, one-leg standing posture on a 5-cm platform with the front of the foot grounded and the upper limb resting on a wall or other support to maintain balance. 1 second to raise, 3 seconds to lower, 60% of the maximum number of repetitions measured before the intervention. After a break, the opposite side is performed. This exercise is performed 3 days a week for 8 weeks.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Young healthy adult males between the ages of 18 and 30 at the time of consent, who are able to obtain written consent from the individual to participate in the research of their own free will.
Key exclusion criteria
Exclude those who routinely perform resistance training, those with ankle joint movement disorders, and those with cardiovascular disease, including venous disease.
Target sample size
30
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
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba 286-8686 JAPAN
TEL
0476-20-7701
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
0476-20-7701
Homepage URL
shinta.t@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
No research funding
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
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 05 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059466
