Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062401) titled 'Effect of Brisk Walking Combined with Slow-Pace Diaphragmatic Breathing on Cardiovascular Disease Risk in Chronic Disease Management Program (Prolanis) Participants' on July 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Hasanuddin University
Condition:
Condition - Hypertension and/or Type 2 Diabetes Mellitus in Prolanis (Chronic Disease Management Program) participants at risk of cardiovascular disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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).
Eligibility:
Age-lower limit - 50
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 Size - 80
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071370
Disclaimer: Curated by HT Syndication.
