Tests an exercise program to prevent falls in older adults with type 2 diabetes
Tests the Otago exercise program to prevent falls in older adults with diabetes.
Key facts
- Who runs it
- National Geriatric Hospital
- Where
- Hanoi, VietnamSee the site
- Trial code
- Registry title
- Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 1 Mar 2024
- Planned end
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Otago exercise program
- Record updated
- 13 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for older adults with type 2 diabetes who are at moderate or high risk of falling. It tests an exercise program (Otago) to prevent falls.
- Age
- 60 to 80 years (the record lists both the minimum and maximum age as 60 years).
- Sex
- Men and women can join.
- Disease stage
- Type 2 diabetes with HbA1c of at least 7.0 and at most 9%. For the follow-up part, a moderate or high risk of falls is needed.
- Biomarker or test result
- HbA1c of 7.0 to 9% (53–75 mmol/mol).
Main reasons for not taking part
- Acute diabetic complications
- Acute musculoskeletal problems such as acute gout, acute joint pain or sciatic pain
- Conditions that greatly affect thinking or movement, such as after-effects of stroke, severe heart failure, severe cognitive decline or psychiatric disorders
- Bedridden for more than one month in the past three months
- Heart and blood vessel disease such as chest pain, uncontrolled blood pressure of 160/100 mmHg or higher, or untreated heart rhythm problems
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Acute diabetic complications
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 60 years old?
Where in Vietnam
- National Geriatric HospitalHanoi, VietnamContact: Huyen TT Vu, PhDTaking people
About the trial
What the trial wants to find out
.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:
Read full original descriptionShow less
* 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.
The 2 groups in the trial
- Intervention groupTreatment being tested
The intervention group receives supervised Otago exercise program and baseline treatment for type2 diabetes mellitus: The Otago exercise program aims to increase muscle strength and improve the patient's balance. The training duration is 24 weeks, the frequency is thrice a week, and the intensity gradually increases based on the Personal Therapist (PT) assessment. Baseline treatment for diabetes: Recommendations according to American Diabetes Association guidelines, which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients
Treatment: Otago exercise program
- Control groupNo study treatment, for comparison
The control group receives the baseline treatment for type2 diabetes mellitus: Baseline treatment for diabetes: Recommendations according to American Diabetes Association guidelines, which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
- Plain-language title
- Tests an exercise program to prevent falls in older adults with type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06345118, who can take part
- Record updated
- 13 November 2024