UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059073 |
|---|---|
| Receipt number | R000067568 |
| Scientific Title | Comparison the effect of group Vivi frail exercise program and locotra exercise program on motor and psychological performance in older adults with locomotive syndrome |
| Date of disclosure of the study information | 2025/12/03 |
| Last modified on | 2025/09/12 14:11:22 |
* 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
The effect of exercise on locomotive syndrome in the elderly
Acronym
Research on the elderly
Scientific Title
Comparison the effect of group Vivi frail exercise program and locotra exercise program on motor and psychological performance in older adults with locomotive syndrome
Scientific Title:Acronym
"Comp. Effect of Vivi & Locotra Exercise on Motor & Psychological Performance in Older Adults with Locomotive Syndrome"
Region
| Asia(except Japan) |
Condition
Condition
Locomotive Syndrome
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of eight weeks of group training using V-V-Friel and Lokotra exercises on the motor and psychological performance of elderly individuals with movement syndrome.
Basic objectives2
Others
Basic objectives -Others
To assess the improvement in balance and muscle strength in elderly participants.
To evaluate changes in quality of life and psychological performance post-training.
To compare the effectiveness of V-V-Friel versus Lokotra training methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor Function Assessment: Measured using the Timed Up and Go (TUG) test at baseline, 4 weeks, and 8 weeks. This outcome will assess improvements in mobility and balance.
Key secondary outcomes
Psychological Performance:
Measured using the Geriatric Depression Scale (GDS) at baseline, 4 weeks, and 8 weeks to evaluate changes in mood and psychological well-being.
Quality of Life:
Assessed using the Short Form Health Survey (SF-36) at baseline, 4 weeks, and 8 weeks to determine overall health and quality of life improvements.
Muscle Strength:
Evaluated through handgrip strength measurements at baseline, 4 weeks, and 8 weeks to track changes in muscular strength.
Functional Independence:
Measured using the Barthel Index at baseline, 4 weeks, and 8 weeks to assess improvements in daily living activities.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Type of Intervention: vivifrail group
Duration: 8 weeks
Amount:60 minutes per session
Frequency: 3 times a week
Interventions/Control_2
Type of Intervention: locotra exercise program
Duration: 8 weeks
Amount: 60 minutes per session
Frequency: 3 times a week
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
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Age: Participants aged 60 years and older.
Health Status: Diagnosed with a movement disorder or related condition.
Mobility: Ability to participate in physical activity as assessed by a mobility test.
Consent: Provide informed consent to participate in the study.
Key exclusion criteria
Severe Medical Conditions: Individuals with severe cardiovascular, respiratory, or orthopedic conditions that would limit participation.
Cognitive Impairment: Participants with significant cognitive impairment that affects their ability to follow instructions.
Recent Surgery: Those who have undergone surgery within the last six months.
Participation in Other Trials: Individuals currently involved in other clinical trials.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Parnian |
| Middle name | |
| Last name | Rashidy |
Organization
University of Isfahan
Division name
sport science
Zip code
81746-73441
Address
University St., Isfahan 81746-73441, Iran
TEL
989374453554
rashidyparnian@gmail.com
Public contact
Name of contact person
| 1st name | Parnian |
| Middle name | |
| Last name | Rashidy |
Organization
University of Isfahan
Division name
sport science
Zip code
81746-73441
Address
University St., Isfahan 81746-73441, Iran
TEL
989374453554
Homepage URL
rashidyparnian@gmail.com
Sponsor or person
Institute
University of Isfahan
Institute
Department
Personal name
Funding Source
Organization
University of Isfahan
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
University of Isfahan
Address
University St., Isfahan 81746-73441, Iran
Tel
+98 313 793 2039-40
int-office@ui.ac.ir
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
| 2025 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
https://scholar.google.com/citations?user=JpdZADgAAAAJ&hl=en
Publication of results
Partially published
Result
URL related to results and publications
https://scholar.google.com/citations?user=JpdZADgAAAAJ&hl=en
Number of participants that the trial has enrolled
50
Results
4
Results date posted
| 2025 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Demographic Information:
Age: Average age of participants.
Gender: Distribution of male and female participants.
Ethnicity: Ethnic backgrounds of participants.
Health Status:
Chronic Conditions: Prevalence of conditions such as diabetes, hypertension, arthritis, etc.
Cognitive Function: Assessment of cognitive abilities, possibly using standardized tests.
Physical Functioning:
Mobility: Baseline measures of mobility, such as gait speed or balance assessments.
Strength: Initial measurements of muscle strength, particularly in upper and lower limbs.
Psychological Factors:
Depression Levels: Use of standardized questionnaires (e.g., GDS-15) to assess depression.
Quality of Life: Baseline quality of life assessments using tools like OPQOL-35.
Lifestyle Factors:
Physical Activity Levels: Baseline activity levels, possibly measured through self-reports or accelerometers.
Nutritional Status: Information on dietary habits or nutritional assessments.
Social Factors:
Living Arrangements: Whether participants live alone, with family, or in assisted living facilities.
Social Support: Assessment of social networks and support systems.
Participant flow
Screening Phase
Total participants assessed for eligibility
Eligible participants
Participants who consented to participate
Randomization Phase
Participants randomized into groups (e.g., intervention vs. control)
Number of participants in each group
Intervention Phase
Participants who completed the intervention
Participants who dropped out, along with reasons for dropout
Follow-Up Phase
Participants assessed at follow-up
Reasons for loss to follow-up
Analysis Phase
Participants included in the final analysis
Reasons for exclusion from analysis
Adverse events
Types of Adverse Events:
Physical injuries (e.g., falls, strains)
Psychological effects (e.g., anxiety, depression)
Other health-related issues (e.g., exacerbation of pre-existing conditions)
Reporting:
All adverse events should be documented during the study.
Serious adverse events must be reported immediately to the ethics committee.
Analysis of adverse events should be included in the final report to assess the safety of the interventions.
Outcome measures
Primary Outcome Measures:
Motor performance (e.g., balance, strength)
Psychological performance (e.g., mood, anxiety levels)
Secondary Outcome Measures:
Quality of life (assessed through validated questionnaires)
Functional independence (ability to perform daily activities)
Specific metrics related to the interventions (e.g., walking speed, endurance)
Assessment Tools:
Standardized questionnaires (e.g., GLFS-25 for locomotive syndrome)
Physical tests (e.g., SPPB for balance and mobility)
Psychological assessments (e.g., GDS-15 for depression)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067568
