UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024416 |
|---|---|
| Receipt number | R000028090 |
| Scientific Title | 1. Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes. 2. Effectiveness of tele-guidance for physiotherapy in older patients with type 2 diabetes: A randomized controlled trial (TelePhysioT2D trial) |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2025/11/22 14:28:56 |
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Basic information
Public title
1. Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
2. Effectiveness of tele-guidance for physiotherapy in older patients with type 2 diabetes: A randomized controlled trial (TelePhysioT2D trial)
Acronym
1. Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
2. Effectiveness of tele-guidance for physiotherapy in older patients with type 2 diabetes: A randomized controlled trial (TelePhysioT2D trial)
Scientific Title
1. Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
2. Effectiveness of tele-guidance for physiotherapy in older patients with type 2 diabetes: A randomized controlled trial (TelePhysioT2D trial)
Scientific Title:Acronym
1. Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
2. Effectiveness of tele-guidance for physiotherapy in older patients with type 2 diabetes: A randomized controlled trial (TelePhysioT2D trial)
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 a regular semipersonalized support for exercise therapy by text-messages or calls on muscle strength, muscle mass and glycemic control in elderly patients with diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle strength
Key secondary outcomes
Skeletal muscle mass
Mortor function
Glycemic control
Satisfaction with the exercise therapy
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
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Regular support by text-messages or calls in addition to usual care during the half year.
Interventions/Control_2
To implement the usual care in outpatient setting during the half year.
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
| 65 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes mellitus
Key exclusion criteria
1. Patients with bone and joint disease or cerebral vascular disease.
2. Patients whose daily activities and highly restricted.
3. Patients with acute metabolic disorders.
4. Patients with severe chronic complications of diabetes.
5. Patients who seem inappropriate for this study by investigations.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Nomura |
Organization
Kansai Medical University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
573-1010
Address
2-5-1, shinmachi, Hirakata, Osaka, Japan
TEL
072-804-0101
nomurata1017@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kataoka |
Organization
Okayama Healthcare Professional University
Division name
Department of Physical Therapy
Zip code
700-0913
Address
3-2-18, Daiku, Kitaku, Okayama-city, Okayama, 700-0913, Japan
TEL
086-233-8020
Homepage URL
http://ptdm.jp/program1.html
h.kataoka59@gmail.com
Sponsor or person
Institute
Kansai University of Welfare Sciences
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
Hiroshima University Hospital
Sanuki Municipal Hospital
Kimitsu Chuo Hospital
Chiba central Medical Center
Shuto General Hospital
Sakaide City Hospital
Misaki Naika Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KKR Takamatsu Hospital
Address
4-18, Tenjinmae, Takamatsu-city, Kagawa, 760-0018, Japan
Tel
087-861-3261
irb@kkr-ta-hp.gr.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
KKR高松病院（香川県），さぬき市民病院（香川県），君津中央病院（千葉県），千葉中央メディカルセンター（千葉県），周東総合病院（山口県），坂出市立病院（香川県），三咲内科クリニック（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jpfsm/9/2/9_89/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40219654/
Number of participants that the trial has enrolled
74
Results
Knee extension force significantly increased in the TelePhysio group, whereas it significantly decreased in the non-intervention group. Hemoglobin A1c levels improved significantly in both groups, but adherence to the exercise program was significantly higher in the TelePhysio group than in the non-intervention group (71.8% vs 48.6%). These findings indicate that weekly TelePhysio is effective in improving muscle strength and enhancing adherence to physiotherapy in older patients with type 2 diabetes.
Results date posted
| 2025 | Year | 11 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 74 older patients with type 2 diabetes were included in the analysis (tele-guidance for physiotherapy group, n=39; non-intervention group, n=35). The mean ages were approximately 74 and 73 years, respectively, and about 45% of participants were men. Both groups had a mean body mass index of around 23 to 25 kg/m2 and a diabetes duration of roughly 11 years; baseline glycemic control was poor, with mean HbA1c levels of about 10%. Diabetic polyneuropathy was present in approximately half of the participants, retinopathy in about one quarter to one third, and nephropathy in roughly 6 to 15%. There were no significant between-group differences in any clinical indicators at baseline, confirming the comparability of the groups.
Participant flow
In total, 93 patients were assessed for eligibility. Nineteen were not enrolled (12 met exclusion criteria, 5 declined to participate, and 2 were excluded for other reasons), and 74 patients were randomized to either the tele-guidance for physiotherapy group (n=39) or the non-intervention group (n=35). There were no dropouts during the 6-month follow-up, and all randomized participants were included in the primary analysis.
Adverse events
Throughout the 6-month intervention period, no exercise-related or serious adverse events were observed in either the tele-guidance for physiotherapy group or the non-intervention group.
Outcome measures
The primary outcome was the change in knee extension force (KEF) after 6 months of intervention. Secondary outcomes were changes in skeletal muscle mass and indices of glycemic control, including fasting plasma glucose and HbA1c. In addition, exploratory outcomes included motor function measures (one-leg standing time, functional reach, and 10-m walking speed), health-related quality of life assessed using the EQ-5D, and physical activity assessed using the short version of the International Physical Activity Questionnaire (IPAQ).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 30 | Day |
Other
Other related information
https://pmc.ncbi.nlm.nih.gov/articles/PMC12209514/
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028090
