UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058378 |
|---|---|
| Receipt number | R000045213 |
| Scientific Title | The effect of resistance training on brachial ankle index, blood pressure and bone morphogenetic protein 4 in type-2 diabetic women with peripheral neuropathy |
| Date of disclosure of the study information | 2025/07/06 |
| Last modified on | 2025/07/06 22:55:11 |
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Basic information
Public title
The effect of resistance training on brachial ankle index, blood pressure and bone morphogenetic protein 4 in type-2 diabetic women with peripheral neuropathy
Acronym
Effect of training on bone morphogenetic protein 4 in type-2 diabetic
Scientific Title
The effect of resistance training on brachial ankle index, blood pressure and bone morphogenetic protein 4 in type-2 diabetic women with peripheral neuropathy
Scientific Title:Acronym
Effect of training on bone morphogenetic protein 4 in type-2 diabetic
Region
| Asia(except Japan) |
Condition
Condition
women diabetic type2
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Effect of resistance training on bone morphogenetic protein 4 in type-2 diabetic Women with peripheral neuropathy.
2)Effect of resistance training on Ankel Brachial Index (ABI)in type-2 diabetic Women with peripheral neuropathy.
3)Effect of resistance training on Blood sugar levels in type-2 diabetic Women with peripheral neuropathy.
4)Effect of resistance training on Insulin in type-2 diabetic Women with peripheral neuropathy.
5)Effect of resistance training on HOMA-IR in type-2 diabetic Women with peripheral neuropathy.
6)Effect of resistance training on Weight in type-2 diabetic Women with peripheral neuropathy
7)Effect of resistance training on Body Mass Index in type-2 diabetic Women with peripheral neuropathy
8)Effect of resistance training on Body fat percentage in type-2 diabetic Women with peripheral neuropathy
9)Effect of resistance training on Systolic Blood Pressure in type-2 diabetic Women with peripheral neuropathy
10)Effect of resistance training on Diastolic Blood Pressure in type-2 diabetic Women with peripheral neuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone Morphogenetic Protein 4 (BMP4).(pree test and post test)
Ankel Brachial Index (ABI) .(pree test and post test)
Body fat percentage (pree test and post test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Resistance training group (for a three-month research program):
The resistance training protocol will consist of a circuit of 11 dynamic exercises targeting large muscle groups using free weights and machines, including full-body exercises: squats, bench press, shoulder press, lat pull-downs, calf raises, leg extensions, hamstring curls, bicep curls, and triceps pushdowns, with each exercise to be performed at 50 to 60% of 1RM for 10 to 15 repetitions across 1 to 3 sets. Rest intervals of 30 to 60 seconds will be allowed between each exercise, and 3 to 5 minutes between each circuit. The program will include three training sessions per week, along with 15 minutes of light jogging and active stretching for warm-up and cool-down, and 10 minutes of light jogging and passive stretching for cool-down at the end of each session.
Interventions/Control_2
control group(for a three-month research program): no treatment. Continue their former lifestyle.
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1)BMI>25
2)Menopause
3)No skeletal disease
4)History of diabetes at least 5 years
5)Maximum blood pressure 160 /95 mmHg
7)Fasting blood sugar at least 126
9)Lack of metabolic conditions other than type2 diabetes
10)Diabetic peripheral neuropathy diagnosis (diabetic neuropathy diagnosis based on Michigan screening)
11)No diabetic foot ulcers and orthopedic problems.
12)No regular exercise.
13)No medical contraindication to exercise(The necessary criteria for the subjects' physical activity level will be determined using the International Physical Activity Questionnaire (IPAQ)).
Key exclusion criteria
1)Insulin therapy
2)Infectious diseases
3)Having skeletal diseases
4)3 sessions of obsenteeism
5)Metabolic conditions Except type2 diabetes
6)Lack of interest in continuing at any stage of the research
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naeimeh |
| Middle name | |
| Last name | Nourmohammadian |
Organization
Shahrood University Of Technology
Division name
Physical Education and Sport Sciences
Zip code
3619995161
Address
Shahrood, Haft Tir Square, Shahrood University of Technology
TEL
098-2332395900
Nourmohammadian1990@yahoo.com
Public contact
Name of contact person
| 1st name | adel |
| Middle name | |
| Last name | donyaei |
Organization
Shahrood University Of Technology
Division name
Physical Education and Sport Sciences
Zip code
3619995161
Address
Shahrood, Haft Tir Square, Shahrood University of Technology
TEL
098-2332395900
Homepage URL
adelldonyai@yahoo.com
Sponsor or person
Institute
Shahrood University Of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University Of Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Shahrood University of Technology
Address
Shahrood, Haft Tir Square, Shahrood University of Technology, Faculty of Physical Education and Sport Sciences
Tel
098-2332395900
Ethics.C@shahroodut.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 | 07 | Month | 06 | 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
30
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045213
