UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039519 |
|---|---|
| Receipt number | R000045070 |
| Scientific Title | Effect of combined aerobic- resistance training and subsequent detraining on brain-derived neurotrophic factor (BDNF) and depression in women with type 2 diabetes mellitus: a randomized controlled trial |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2023/05/15 20:24:11 |
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Basic information
Public title
Effect of combined training and detraining on basal BDNF levels and depression index in type 2 diabetic women with depression
Acronym
Effects of exercise on BDNF and depression in women with Type 2 diabetes
Scientific Title
Effect of combined aerobic- resistance training and subsequent detraining on brain-derived neurotrophic factor (BDNF) and depression in women with type 2 diabetes mellitus: a randomized controlled trial
Scientific Title:Acronym
Effect of aerobic- resistance training and subsequent detraining on brain-derived neurotrophic factor and depression in women with type 2 diabetes
Region
| Asia(except Japan) |
Condition
Condition
type 2 diabetic women with depression
Classification by specialty
| Psychiatry | Operative medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Overall purpose:The effect of combined training and detraining on basal BDNF levels and depression index in type 2 diabetic women with depression
Partial Goals:
The effect of combined training and detraining on Beck test score in type 2 diabetic women with depression
Effects of combined training and detraining on basal BDNF levels in type 2 diabetic women with depression
The effect of combined training and detraining on fat percentage in type 2 diabetic women with depression
Correlation between BDNF and depression in type 2 diabetic women with depression
The effect of combined training and detraining on basal insulin levels in type 2 diabetic women with depression
Effects of combined training and detraining on fasting blood glucose levels in type 2 diabetic women with depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
basal BDNF levels(pre test,post test,detraining)
Beck test score(pre test,post test,detraining)
fat percentage(pre test,post test,detraining)
basal insulin levels(pre test,post test,detraining)
fasting blood glucose levels(pre test,post test,detraining)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Moderate intensity cimbined training (50-70% maximal heart rate reserve (HRR) and 50-70% 1 repetition maximom (1RM)), three times a week, for 12 weeks and each session 60 minutes.
Each session consists of 15 minutes of warm-up, 20 minutes of aerobic exercise (walking and running on the treadmill) and resistance training (whole body exercises including: Incline Bench Press, shoulder press, wide-grip lat pulldown, leg press, leg extensions, Lying Leg Curls , biceps and triceps pushdown,crunch) are circular, 12 repetitions, 3 rounds, with a 2-3 minute break between rounds and 10 minutes of stretching exercises to cool down.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) BMI> 25
2) Menopause
3) No skeletal disease
4) Diabetes history of at least 4 years
5) Diagnosis of moderate depression by Beck test (score above 20)
6) blood pressure 160 to 95 mm Hg (maximum)
7) Age of menopause to 75 years
8) sedentary lifestyle for at least 6 months
9) glycemic control drugs
10) no metabolic conditions other than type 2 diabetes
11) fasting blood sugar at least 126
Key exclusion criteria
1) Insulin therapy
2) Infectious disease
3) Skeletal disease
4) 3 sessions of no training
5) Malignant or known dementia
6) Metabolic conditions other than T2DM
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Elina |
| Middle name | |
| Last name | Kiani Shahvandi |
Organization
Sahrood University of Technology
Division name
Sport Science,Sport physiology
Zip code
3619995161
Address
Shahrood,Seventh Tir Square,Shahrood University of Technology
TEL
00989364747539
elina.kiani@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Elina |
| Middle name | |
| Last name | Kiani Shahvandi |
Organization
Shahrood University of Technology
Division name
Sport Science,Sport physiology
Zip code
3619995161
Address
Shahrood,Seventh Tir Square,Shahrood University of Technology
TEL
00989364747539
Homepage URL
elina.kiani@shahroodut.ac.ir
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
Shahrood University of Technology
Address
Shahrood,Seventh Tir Square,Shahrood University of Technology
Tel
00982332392204
elina.kiani@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
| 2020 | Year | 02 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045070
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