UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054333 |
|---|---|
| Receipt number | R000062069 |
| Scientific Title | The effectiveness of stretching exercise with behavior change techniques on flexibility and exercise adherence |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2024/10/08 10:33:40 |
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Basic information
Public title
The effectiveness of stretching exercise with behavior change techniques on flexibility and exercise adherence
Acronym
The effectiveness of stretching exercise with behavior change techniques on flexibility and exercise adherence
Scientific Title
The effectiveness of stretching exercise with behavior change techniques on flexibility and exercise adherence
Scientific Title:Acronym
The effectiveness of stretching exercise with behavior change techniques on flexibility and exercise adherence
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness of stretching exercises with behavior change techniques on flexibility and exercise adherence, compared with stretching exercises only.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Flexibility: Sit-and-reach test (cm)
Timepoints: After the intervention period (28 days)
Key secondary outcomes
1. Exercise adherence: Self-reported number of exercise sessions completed during the intervention period (28 days)
Timepoints: Recorded daily during the 28-day intervention period
2. Barriers of exercise: Questionnaire
Timepoints: After the intervention period (28 days)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Stretching exercise and behavior change techniques
Interventions/Control_2
Stretching exercise only
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
1. Participants who agree to join the study
2. Participants who can understand Japanese language
3. Participants who can join the 28-day intervention period
4. Participants who can receive email
Key exclusion criteria
1. Participants who have a history of surgery in spine or lower extremity
2. Participants who currently have orthopedic diseases and are receiving treatment
3. Participants who have difficulty with reading emails and questionnaires
4. Participants who can touch the floor in the Fingertip-to-Floor test (joint hypermobility)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ariie |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu, Okawa, Fukuoka, Japan
TEL
0944-89-2000
tariie@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ariie |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu, Okawa, Fukuoka, Japan
TEL
0944-89-2000
Homepage URL
tariie@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
137-1 Enokizu, Okawa, Fukuoka, Japan
Tel
0944-89-2000
q-rinri@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
| 2024 | Year | 05 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062069
