UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060445 |
|---|---|
| Receipt number | R000069152 |
| Scientific Title | Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease Prospective, randomized, open-label, parallel-group, delayed-release study |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/23 08:42:04 |
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Basic information
Public title
Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease
Prospective, randomized, open-label, parallel-group, delayed-release study
Acronym
Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease
Scientific Title
Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease
Prospective, randomized, open-label, parallel-group, delayed-release study
Scientific Title:Acronym
Effect of static stretching exercise intervention on walking ability and quality of life in patients with lower limb arterial disease
Region
| Japan |
Condition
Condition
lower limb arterial disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the extent to which exercise intervention using static stretching significantly improves walking ability, physical function, and quality of life in patients with LEAD compared with conventional CR, which focuses on aerobic exercise.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walking distance
Key secondary outcomes
Walking Inpairment Questionnaire
MOS 36-Item Short-Form Health Survey
Cardio Ankle Vascular Index
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A static stretching program will be performed at home for a total of 30 minutes per day, three times a week for 12 weeks. Stretching will be performed using an ankle dorsiflexion splint , targeting the triceps surae. At the first intervention, the principal investigator will explain the procedure and visually check the attachment of the device to ensure safety. Patients will be contacted by phone at weeks 1, 2, 6, and 12 to confirm the implementation status and whether the stretches are being performed effectively. After the 12-week period, supervised CR will be implemented immediately.
Interventions/Control_2
Patients are instructed to perform standard CR programs (such as treadmill walking) at least once per week, aiming for a total of three exercise therapy sessions per week including unsupervised sessions. Exercise status during unsupervised sessions is confirmed by CR staff at each visit.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age 20 or older
2.Patients with intermittent claudication and a physician's diagnosis of LEAD
3.ABI < 0.9
4.Participants must have received a thorough explanation of this study and provided written informed consent.
5.Participants must be able to undergo static stretching and be available for regular daytime phone calls.
Key exclusion criteria
1.Individuals under the age of 20
2.Individuals deemed unsuitable for participation in this study by their attending physician
3.Individuals with complications contraindicating exercise or considered to be at high risk for exercise.
4.Individuals deemed otherwise unsuitable as research subjects by the principal investigator
5.Among the research subjects described in 1 above, eligibility is determined by satisfying all selection criteria in 2 and not meeting any exclusion criteria in 3.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yusei |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Hospital
Division name
Cardiovascular Rehabilitation & Fitness
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo Ward, Tokyo
TEL
03-3813-3111
y.sato.kc@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusei |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Hospital
Division name
Cardiovascular Rehabilitation&Fitness Room
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo Ward, Tokyo
TEL
03-3813-3111
Homepage URL
y.sato.kc@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association of Cardiac Rehabilitation
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
Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo Ward, Tokyo
Tel
03-3813-3111
y.sato.kc@juntendo.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
| 2026 | Year | 01 | Month | 30 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069152
