Diagnosis and classification of diabetes mellitus.
American Diabetes Association
https://pubmed.ncbi.nlm.nih.gov/22187472Actively Recruiting
Phase Not Applicable
Age: 60Years - 60Years
All Genders
ID06345118
Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Led by National Geriatric Hospital · Updated on 2024-11-13
80
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating fall prevention in older adults aged 60 to 80 with type 2 diabetes mellitus. The study aims to understand the current situation of falls, the risk factors for falls, and to evaluate the results of fall prevention efforts in this population. This research responds to the high incidence of falls among elderly diabetic patients and the lack of specific fall prevention guidelines for older adults in Vietnam. Participants will be randomly assigned to one of two groups. The intervention group will follow the Otago Exercise Program, which includes strength and balance exercises performed three times a week for 24 weeks, with gradual intensity increases and regular monitoring by a therapist. The control group will receive standard care according to diabetes treatment guidelines, including diet and exercise recommendations. The intervention includes supervised training, follow-up visits, and phone monitoring to support compliance. Throughout the study, physical performance will be assessed using tests like the Timed Up and Go and Berg Balance Scale monthly, along with evaluations of activities of daily living, quality of life, and functional reach before and after the intervention. Participants will complete calendars to monitor falls and exercise adherence over six months. The study focuses on comparing fall rates and physical performance between groups after the intervention period.
CONDITIONS
Brief Title
Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Who Can Participate
Age: 60Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria
- HbA1c between 7.0% and 9%
- Age between 60 and 80 years
- Moderate or high risk of falls according to World Guidelines for Falls Prevention and Management for Older Adults - British Geriatric Society
You will not qualify if you...
- Acute diabetic complications
- Acute phase musculoskeletal disorders such as acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis
- Conditions significantly affecting cognition and mobility including sequelae of stroke with weakness or paralysis, muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders
- Bedridden due to illness for more than one month within the past three months
- Cardiovascular diseases including chest pain, uncontrolled blood pressure ≥160/100 mmHg, untreated cardiac arrhythmia, history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants receive the Otago exercise program consisting of strength and balance exercises performed three times a week at home, supervised through visits and phone calls by a therapist, alongside baseline treatment for type 2 diabetes mellitus.
Minimum 5 in-person visits over the first 8 weeks, then monthly visits through month 6, with weekly phone calls in between
Follow-up
Duration - Up to completion of intervention at 24 weeks
Participants are monitored monthly to assess physical performance and functional abilities after completing the Otago exercise program.
Monthly visits at months 1, 2, 3, 4, 5, and 6
Trial Site Locations
Total: 1 location
1
National Geriatric Hospital
Hanoi, Vietnam, 100000
Actively Recruiting
Loading map...
Research Team
H
Hoa T Dinh, MD
T
Tam N Nguyen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
STOPP/START criteria for potentially inappropriate prescribing in older people: version 2.
Denis O'Mahony, David O'Sullivan, Stephen Byrne...
https://pubmed.ncbi.nlm.nih.gov/25324330Evaluation of Clinical Practice Guidelines on Fall Prevention and Management for Older Adults: A Systematic Review.
Manuel M Montero-Odasso, Nellie Kamkar, Frederico Pieruccini-Faria...
https://pubmed.ncbi.nlm.nih.gov/34910151Global prevalence of diabetes: estimates for the year 2000 and projections for 2030.
Sarah Wild, Gojka Roglic, Anders Green...
https://pubmed.ncbi.nlm.nih.gov/15111519The Pathophysiology of Hyperglycemia in Older Adults: Clinical Considerations.
Pearl G Lee, Jeffrey B Halter
https://pubmed.ncbi.nlm.nih.gov/28325795Age-Related Changes in Glucose Metabolism, Hyperglycemia, and Cardiovascular Risk.
Chee W Chia, Josephine M Egan, Luigi Ferrucci
https://pubmed.ncbi.nlm.nih.gov/3035507513. Older Adults: Standards of Medical Care in Diabetes-2022.
American Diabetes Association Professional Practice Committee
https://pubmed.ncbi.nlm.nih.gov/349648476. Glycemic Targets: Standards of Medical Care in Diabetes-2021.
American Diabetes Association
https://pubmed.ncbi.nlm.nih.gov/33298417Restricted activity days among older adults.
M R Kosorok, G S Omenn, P Diehr...
https://pubmed.ncbi.nlm.nih.gov/1503169