UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053716 |
|---|---|
| Receipt number | R000061176 |
| Scientific Title | Effects of sit-to-stand exercise with dual task to standing balance in healthy young adults: randomized controlled trial |
| Date of disclosure of the study information | 2024/02/27 |
| Last modified on | 2025/07/31 12:42:00 |
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Basic information
Public title
Effects of sit-to-stand exercise with dual task to standing balance in healthy young adults: randomized controlled trial
Acronym
Effects of sit-to-stand exercise with dual task to standing balance: randomized controlled trial
Scientific Title
Effects of sit-to-stand exercise with dual task to standing balance in healthy young adults: randomized controlled trial
Scientific Title:Acronym
Effects of sit-to-stand exercise with dual task to standing balance: randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of sit-to-stand exercise with dual task
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of sit-to-stand exercise with dual task interference and its standing balance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
static and dynamic balance
Key secondary outcomes
kinematic parameters during sit-to-stand
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
sit-to-stand exercise with normal
Interventions/Control_2
sit-to-stand exercise with dual task
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 and Female
Key inclusion criteria
Right-hand dominant
Understand the instructions
Key exclusion criteria
Present or history of orthopedic and neurological disorders
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Morinaga |
Organization
Sendai Seiyo Gakuin College
Division name
Department of Rehabilitation
Zip code
982-0011
Address
4-3-55,nagamachi,taihaku-ku,sendai,Miyagi
TEL
022-393-9203
y_morinaga@seiyogakuin.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Morinaga |
Organization
Sendai Seiyo Gakuin College
Division name
Department of Rehabilitation
Zip code
982-0011
Address
4-3-55,nagamachi,taihaku-ku,sendai,Miyagi
TEL
022-393-9203
Homepage URL
y_morinaga@seiyogakuin.ac.jp
Sponsor or person
Institute
Sendai Seiyo Gakuin College
Institute
Department
Personal name
Yu Morinaga
Funding Source
Organization
Sendai Seiyo Gakuin College
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
Sendai Seiyo Gakuin College Research Ethics Review Committee
Address
3-5-75,itsutsubashi,wakabayashi-ku,sendai,Miyagi
Tel
022-369-8000
e_kumaki@hokuto.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 | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
Results
The mean value of COP in the anterior direction after intervention with dual task group was significantly longer than before intervention. The coefficient of variation of the forward movement distance of COG when standing up on the 14th day in the single task was significantly smaller than on the 1st day, but there was no significant difference before and after the intervention in the dual task group.
Results date posted
| 2025 | Year | 07 | Month | 31 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Paper submission in progress
Date of the first journal publication of results
Baseline Characteristics
There were 38 study individuals, including 18 in the DT group, 18 in the control group, and 2 dropouts. The two participants excluded from the analysis were one who withdrew midway through the intervention sessions and one for whom post-intervention evaluation was not feasible. The total number of participants included in the analysis was 36,15 males and 21 females. The mean ages of the DT group and Control group were 20.6 years and 20.3 years, respectively. No significant differences were observed between the two groups in terms of age, height, or weight.
Participant flow
Research information and explanation, Consent,Confirmation of eligibility to participate,Participation in and implementation of research,Data collection,Reporting of results
Adverse events
nothing
Outcome measures
The outcomes were the length of the trajectory at the Center of Pressureas static balance, the COP-LNG and mean value of COP in the anterior-posterior direction, and the coefficient of variation of the forward movement distance of the Center of Gravity when standing up.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061176
