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

Last updated: November 12, 2024
Sponsor: National Geriatric Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

Otago exercise program

Clinical Study ID

NCT06345118
FallpreventT2DMelderly
  • Ages 60-60
  • All Genders

Study 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

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 offalls according to the criteria of World Guidelines for Falls Prevention andManagement for Older Adults - British Geriatric Society.

Exclusion

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, sciaticpain, and infectious arthritis.

  • Patients suffer from conditions significantly affecting cognition and mobility:sequelae of stroke (with weakness, limb paralysis), muscular weakness, limbdisabilities, severe heart failure, severe cognitive decline, and psychiatricdisorders.

  • Patients have been bedridden due to illness for more than one month within the pastthree 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 hypertrophiccardiomyopathy.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Otago exercise program
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The proportion of the elderly population is increasing remarkably worldwide. The United Nations estimates there will be 727 million people aged 65 and older in 2020. According to the World Bank, Vietnam is one of the countries with the fastest population aging rate. Diabetes mellitus type 2 (T2DM) is a major public health problem, and the prevalence of T2DM increases exponentially with age. T2DM is also common in older people, and it has been estimated that approximately 25% of the patients with diabetes are over 65. There are an estimated 3.99 million people with diabetes aged 20-79 in 2021 in Vietnam, and this population will reach 6.01 million by 2045. Besides T2DM, the older adult is often faced with a myriad of health-related issues and problems, with falling being one primary concern for persons over 65 years of age. The high prevalence of falls in elderly individuals with DM is well established, with reported annual incidence rates up to 39%. Falls are linked to increased fracture risk and hospitalization for trauma. Recurrent falls can have a significant impact on social and physical activities, as well as quality of life. Falls cause about 2.8 million injuries treated in emergency departments annually, including over 800,000 hospitalizations and over 27,000 deaths. The entire cost of fall injuries in 2013 was $34 billion. The key to fall prevention is identifying persons at risk and implementing the appropriate intervention. Although there are standard fall prevention guidelines worldwide, such as those of the American Geriatrics Society or the British Geriatrics Society, in Vietnam, there are no specific guidelines for screening and preventing falls for older people. Besides, the lack of research on the rate of falls in older people in Vietnam creates a gap in optimizing treatment for elderly diabetes patients, especially when diabetes complications are one of the leading causes of increased fall rates. This study aims to evaluate the rate of falls in elderly diabetic patients treated as outpatients at a National Geriatric Hospital (NGH) and then conduct fall prevention interventions using the Otago Exercise Program (OEP) as the primary method. The study will be submitted and approved by the National Geriatric Hospital Ethics Committee and Hanoi Medical University Ethics Committee, Vietnam, and written consent was obtained from all participants.

Connect with a study center

  • National Geriatric Hospital

    Hanoi, 100000
    Vietnam

    Active - Recruiting

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