NCT06345118Recruiting
Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
.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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- National Geriatric Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06345118
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Mar 2024 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Acute diabetic complications
Who the study is looking for
- 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.
Age in the registry: 60 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Geriatric Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.