UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062401 |
|---|---|
| Receipt number | R000071370 |
| Scientific Title | Effect of Adding Brisk Walking and Slow-Pace Diaphragmatic Breathing to Standard Prolanis Exercise on Cardiovascular Disease Risk Reduction, Measured by AHA PREVENT and JAKVAS Scores, among Prolanis Participants with Hypertension and/or Type 2 Diabetes Mellitus: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/30 08:19:00 |
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Basic information
Public title
Effect of Brisk Walking Combined with Slow-Pace Diaphragmatic Breathing on Cardiovascular Disease Risk in Chronic Disease Management Program (Prolanis) Participants
Acronym
BWSDB-Prolanis Trial
Scientific Title
Effect of Adding Brisk Walking and Slow-Pace Diaphragmatic Breathing to Standard Prolanis Exercise on Cardiovascular Disease Risk Reduction, Measured by AHA PREVENT and JAKVAS Scores, among Prolanis Participants with Hypertension and/or Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Scientific Title:Acronym
BWSDB-Prolanis RCT
Region
| Asia(except Japan) |
Condition
Condition
Hypertension and/or Type 2 Diabetes Mellitus in Prolanis (Chronic Disease Management Program) participants at risk of cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of adding a combination of brisk walking and slow-pace diaphragmatic breathing to standard Prolanis exercise, compared with standard Prolanis exercise alone, on the reduction of cardiovascular disease risk, measured by the change (delta) in AHA PREVENT Score and JAKVAS Score, among Prolanis participants with hypertension and/or type 2 diabetes mellitus at primary healthcare centers (FKTP) in Bulukumba Regency, Indonesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change (delta) in AHA PREVENT Score and JAKVAS Score from baseline to week 8, compared between the intervention group and the control group.
Key secondary outcomes
1. Change in systolic and diastolic blood pressure
2. Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
3. Change in fasting blood glucose (GDP)
4. Change in HbA1c (exploratory)
5. Change in mid-upper arm circumference (LILA) as a supplementary nutritional status indicator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Intervention group is Standard Prolanis exercise (1 session/week, Friday, 30 - 60 minutes, per BPJS Kesehatan protocol) PLUS combined brisk walking (30 minutes at 50 - 70% maximum heart rate) followed by slow-pace diaphragmatic breathing (6 minutes at 6 breaths/minute), 1 session/week (Monday). Total 16 sessions over 8 weeks (8 standard Prolanis sessions plus 8 combined intervention sessions).
Interventions/Control_2
Control group is Standard Prolanis exercise (1 session/week, Friday, 30 - 60 minutes, per BPJS Kesehatan protocol) PLUS a health education session on hypertension and type 2 diabetes mellitus (10 minutes/session, 1 session/week, Monday), without brisk walking or diaphragmatic breathing. Total 16 sessions over 8 weeks (8 standard Prolanis sessions plus 8 health education sessions, 10 minutes each).
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Signed informed consent to participate until study completion.
2. Registered as an active Prolanis participant at the study FKTP with a diagnosis of hypertension and/or type 2 diabetes mellitus.
3. Age 50-65 years.
4. Regular attendance at Prolanis exercise sessions (at least once per month over the past 3 months) with commitment to continued participation during the study.
5. Able to walk independently without assistive devices.
6. No contraindication to physical exercise based on physician examination (functional capacity equivalent to at least 4 METs).
7. Regular use of antihypertensive and/or antidiabetic medication for at least 3 months before recruitment, with a stable regimen
Key exclusion criteria
1. Diagnosed cardiovascular disease like coronary heart disease, heart failure, significant arrhythmia, or stroke within the past 12 months.
2. Uncontrolled chronic obstructive pulmonary disease (COPD) or asthma.
3. Severe musculoskeletal disorder preventing brisk walking.
4. Systolic blood pressure at least 180 mmHg or diastolic at least 110 mmHg at recruitment.
5. Random blood glucose at least 300 mg/dL at recruitment.
6. Currently participating in another structured exercise program outside Prolanis.
7. Grade III obesity.
8. Pregnancy.
9. Cognitive impairment preventing active participation and understanding of exercise instructions.
10. Planned change in medication regimen during the study period, or use of beta-blockers as antihypertensive therapy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Zulaeha |
| Middle name | |
| Last name | Misrayana |
Organization
Hasanuddin University
Division name
Master Program in Biomedical Science
Zip code
55167
Address
Jl. Babaran No. 43, Kelurahan Tahunan, Kecamatan Umbulharjo, Kota Yogyakarta, Daerah Istimewa Yogyakarta 55167, Indonesia
TEL
+6285606855987
zulaehamisrayana@gmail.com
Public contact
Name of contact person
| 1st name | Zulaeha |
| Middle name | |
| Last name | Misrayana |
Organization
Hasanuddin University
Division name
Master Program in Biomedical Science
Zip code
55167
Address
Jl. Babaran No. 43, Kelurahan Tahunan, Kecamatan Umbulharjo, Kota Yogyakarta, Daerah Istimewa Yogyak
TEL
+6285606855987
Homepage URL
zulaehamisrayana@gmail.com
Sponsor or person
Institute
Hasanuddin University
Institute
Department
Personal name
Prof. Dr. dr. Irfan Idris, M.Kes
Funding Source
Organization
Hasanuddin University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Research Ethics Committee, Faculty of Nursing, Hasanuddin University
Address
2nd Floor, Faculty of Nursing, Jl. Perintis Kemerdekaan Km. 10, Kampus Tamalanrea, Makassar 90245, Indonesia
Tel
6285397275009
kepk_fkepuh@unhas.ac.id
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
Caile Primary Health Care Center (Bulukumba), Ponre Primary Health Care Center (Bulukumba), Gantarang Primary Health Care Center (Bulukumba), Bontonyeleng Primary Health Care Center (Bulukumba)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071370
