Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Fall, Elderly Patient

In brief

.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.

Key facts

Study ID

NCT06345118

Run by

National Geriatric Hospital

People needed

80

Starts

2024-03-01

Expected to finish

2025-12-31

Last updated by the study team

2024-11-13

Who can join

Age: 60 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Geriatric Hospital — Hanoi, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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