UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062787 |
|---|---|
| Receipt number | R000071880 |
| Scientific Title | Effects of multiple-load resistance training within a set on muscle strength, muscle hypertrophy and physical function in middle-aged and older adults |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 17:24:32 |
* 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 Multi-Load Resistance Training on Muscle and Physical Function in Middle-Aged and Older Adults
Acronym
MLT Study
Scientific Title
Effects of multiple-load resistance training within a set on muscle strength, muscle hypertrophy and physical function in middle-aged and older adults
Scientific Title:Acronym
MLT Study
Region
| Japan |
Condition
Condition
Age-related decline in muscle mass, muscle strength, and physical function
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of multiple-load within-set resistance training with low-load resistance training on muscle hypertrophy, muscle strength, power, physical function, vascular function, and cognitive function in middle-aged and older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in thigh muscle thickness from baseline to after the 6-week intervention. The sum of rectus femoris and vastus intermedius muscle thickness is assessed 48 to 72 hours after the final training session.
Key secondary outcomes
Secondary outcomes are changes in knee-extension MVC, unloaded and 70 percent 1RM squat lifting velocity, squat-jump performance, 5-m walking time, the 30-second chair-stand test, the five-times sit-to-stand test, lower-body reaction time, the sit-and-reach test, TMT-A, TMT-B, MoCA-J, baPWV, systolic blood pressure, diastolic blood pressure, and heart rate from baseline to after the 6-week intervention. Blood lactate concentration and RPE are assessed once during the sixth, seventh, or eighth training session.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
MLT group: Participants perform supervised resistance training twice per week for 6 weeks, for a total of 12 sessions. For the parallel squat, each set consists of 2 repetitions at 85 percent of 1RM, followed by 3 repetitions at 70 percent of 1RM and 6 repetitions at 55 percent of 1RM. Two sets are performed. All concentric actions are performed with maximal effort. Participants also perform the bench press, lat pulldown, Romanian deadlift, back lunge, and kettlebell swing.
Interventions/Control_2
LL group: Participants perform supervised resistance training twice per week for 6 weeks, for a total of 12 sessions. For the parallel squat, participants perform 4 sets of 6 repetitions at 55 percent of 1RM. All concentric actions are performed with maximal effort. Participants also perform the bench press, lat pulldown, Romanian deadlift, back lunge, and kettlebell swing.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy middle-aged or older adults.
2. Individuals who are able to independently perform a parallel squat.
3. Individuals who are able to participate in supervised training twice per week for 6 weeks, for a total of 12 sessions.
4. Individuals who provide written informed consent after receiving an explanation of the study procedures.
Key exclusion criteria
1. Individuals with pain or musculoskeletal injuries that may interfere with the safe performance of resistance training.
2. Individuals who are unable to perform a parallel squat.
3. Individuals who are unable to participate in supervised training twice per week for 6 weeks, for a total of 12 sessions.
4. Individuals considered unsuitable for participation by the principal investigator for safety or study-related reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kikuchi |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo 158-8508, Japan
TEL
03-5706-0900
n.kikuchi@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Yukina |
| Middle name | |
| Last name | Mochizuki |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo 158-8508, Japan
TEL
03-5706-0900
Homepage URL
mochizuki.y@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Nippon Sport Science University
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
Ethics Committee of Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo 158-8508, Japan
Tel
03-5706-0931
kenkyu@nittai.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
日本体育大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Protocol is not publicly available.
Publication of results
Partially published
Result
URL related to results and publications
https://nittaidai.repo.nii.ac.jp/records/2000942
Number of participants that the trial has enrolled
45
Results
Forty-five participants were randomized, and 35 were analyzed (MLT, n=16; LL, n=19). Blood lactate was higher in MLT than LL (p<0.001). Group-by-time interaction trends were observed for 5-m walking time (p=0.06) and thigh muscle thickness (p=0.07). Significant time effects were observed for unloaded and 70 percent 1RM squat velocity and MoCA-J score (p<0.05).
Results date posted
| 2026 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-five participants were analyzed: 16 in MLT (9 men, 7 women) and 19 in LL (9 men, 10 women). For MLT, age was 53.6 +/- 13.1 years, height 164.3 +/- 7.3 cm, body weight 65.7 +/- 9.7 kg, body fat 26.5 +/- 7.0 percent, and BMI 23.9 +/- 3.1. For LL, age was 55.6 +/- 9.8 years, height 164.2 +/- 8.4 cm, body weight 62.1 +/- 10.4 kg, body fat 23.8 +/- 7.4 percent, and BMI 23.0 +/- 3.1. Data are mean +/- SD.
Participant flow
Fifty-two individuals were assessed for eligibility, and 7 were excluded. Reasons for exclusion were inability to perform a parallel squat (n=2), inability to attend all scheduled training sessions (n=1), and musculoskeletal injury or pain (n=4). Forty-five eligible participants were randomly assigned to the LL group (n=23) or the MLT group (n=22). In the LL group, 4 participants discontinued or were excluded from the final analysis because of family reasons (n=1), infection (n=1), work commitments (n=1), or injury during private life (n=1). Nineteen participants in the LL group were included in the final analysis. In the MLT group, 6 participants discontinued or were excluded from the final analysis because of family reasons (n=1), joint pain of unknown cause (n=1), work commitments (n=1), injury during private life (n=1), failure to meet the attendance criterion (n=1), or infection (n=1). Sixteen participants in the MLT group were included in the final analysis. A total of 35 participants were included in the final analysis.
Adverse events
No serious adverse events were reported. One participant in the MLT group discontinued the intervention because of joint pain of unknown cause. Two participants discontinued because of infection, and 2 participants discontinued because of injuries during private life. A causal relationship between these events and the training intervention was not established.
Outcome measures
The primary outcome measure was the change in thigh muscle thickness from baseline to after the 6-week intervention. Thigh muscle thickness was assessed as the sum of rectus femoris and vastus intermedius muscle thickness. Secondary outcome measures were knee-extension maximal voluntary isometric contraction (MVC), unloaded and 70 percent 1RM squat lifting velocity, squat-jump performance, 5-m walking time, the 30-second chair-stand test, the five-times sit-to-stand test, lower-body reaction time, the sit-and-reach test, TMT-A, TMT-B, MoCA-J, brachial-ankle pulse wave velocity (baPWV), systolic blood pressure, diastolic blood pressure, heart rate, blood lactate concentration, and rating of perceived exertion (RPE). Chronic outcomes were assessed before and after the 6-week intervention. Post-intervention assessments were performed 48 to 72 hours after the final training session. Blood lactate concentration and RPE were assessed once during the sixth, seventh, or eighth training session.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 30 | Day |
Other
Other related information
This trial was registered retrospectively after participant enrollment and completion of the intervention.
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071880
