NCT06345118 Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
| NCT ID | NCT06345118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Geriatric Hospital |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-03-01 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
.This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are: * Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients * Evaluate the results of fall prevention and related factors in the study population. Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities. At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests.
Eligibility Criteria
Inclusion Criteria: For the first objective (Cross-sectional study): * Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria * HbA1c ≥ 7.0 and ≤ 9% * Age ≥ 60 and ≤ 80 For the second objective (Longitudinal study): * All patients recruited from the first objective are at moderate or high risk of falls according to the criteria of World Guidelines for Falls Prevention and Management for Older Adults - British Geriatric Society. Exclusion Criteria: * Acute diabetic complications * Patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis. * Patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders. * Patients have been bedridden due to illness for more than one month within the past three months up to the recruitment time. * Patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160/100 mmHg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy.
Contact & Investigator
Huyen TT Vu, PhD
STUDY CHAIR
National Geriatric Hospital
Frequently Asked Questions
Who can join the NCT06345118 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 60 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06345118 currently recruiting?
Yes, NCT06345118 is actively recruiting participants. Contact the research team at dinhtrunghoa95@gmail.com for enrollment information.
Where is the NCT06345118 trial being conducted?
This trial is being conducted at Hanoi, Vietnam.
Who is sponsoring the NCT06345118 clinical trial?
NCT06345118 is sponsored by National Geriatric Hospital. The principal investigator is Huyen TT Vu, PhD at National Geriatric Hospital. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.