UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042972 |
|---|---|
| Receipt number | R000049058 |
| Scientific Title | Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes |
| Date of disclosure of the study information | 2021/01/11 |
| Last modified on | 2023/07/18 13:11:29 |
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Basic information
Public title
Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Acronym
Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Scientific Title
Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Scientific Title:Acronym
Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of regular stair climbing-descending exercise on glycemic control in people with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Term for evaluation
At baseline, at 12 weeks
Evaluation items
Glycemic control (HbA1c)
Key secondary outcomes
Term for evaluation
At baseline, at 12 weeks
Evaluation items
1. Fasting plasma glucose, homeostasis model assessment of insulin resistance (HOMA-IR)
2. Muscle strength
3. Skeletal muscle mass, body Fat Mass
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
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Regular stair climbing-descending exercise in addition to oral guidance using exercise materials for 12 weeks.
Interventions/Control_2
Oral guidance using exercise materials for 12 weeks.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients with type 2 diabetes
Key exclusion criteria
1. Patients who have been diagnosed with diabetes for less than a year
2. Patients whose daily physical activities restricted by cardiovascular or motor dysfunction
3. Patients with severe chronic complications of diabetes.
4. Patients with cognitive decline
5. Patients who do not have appropriate stairs using study in their living environments
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Honda |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
h-honda@un.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Honda |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
Homepage URL
h-honda@un.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Shijonawate Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shijonawate Gakuen University
Address
5-11-10 Hojo, Daito, Osaka
Tel
072-863-5043
a-matsugi@reha.shijonawate-gakuen.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
公立豊岡病院日高医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2813-0413/2/2/18
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2813-0413/2/2/18
Number of participants that the trial has enrolled
17
Results
Fourteen participants completed the study (seven for each group). The decrease in glycoalbumin levels for 12 weeks was significantly greater in the stair exercise group than in the control group. Moreover, the knee extension force increased greatly in the stair exercise group compared with that in the control group, with no significant change in the skeletal muscle mass.
Results date posted
| 2023 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
16 patients (ages 50-74) with type 2 diabetes without advanced diabetic complications
Participant flow
The participants were randomly divided into two groups, one with stair climbing exercise and the other without (open-label). Stair climbing exercise was performed in each participant's home, and each session consisted of two 3-minute sets of exercise from the first floor to the second floor (11 to 15 steps) and back, with one session performed 60 minutes and/or 120 minutes after meals (any time of the day, morning, noon, or evening). The frequency was set so that there were at least 12 sessions per week and at least 3 days per week. The speed of ascent was 80-110 steps/min, and the speed of descent was left up to the participant. The target intensity was to achieve a subjective exercise intensity of 11-13 on the Borg scale.
Adverse events
No adverse events
Outcome measures
The primary outcome was changes in the HbA1c and glycoalbumin levels from baseline to 12 weeks. The secondary outcome was changes in other metabolic functions, body composition, motor function, and physical activity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049058
