Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
National Geriatric Hospital
80 participants
Mar 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
Exclusion Criteria5
- 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.
Interventions
The OEP consists of 17 strength and balance exercises and a walking program performed thrice a week by the older adult at home. Program Prescription The program is designed to be delivered over 6 months and includes a minimum of 5 visits. The first visit is Day 1 of Otago when performance of the functional measures is assessed, and the exercises are prescribed at the Rehabilitation Center of the National Geriatric Hospital. Then, the therapist will see the patient for 4 visits over an 8-week period (typically every other week). This is considered the initial bolus of Otago. Then, the therapist will follow the patient via phone calls every week and make a visit at three months, four months, five months, and six months to reassess the patient's training ability and compliance. Monitoring: Calendars can be completed each month to document any falls. A calendar or diary can be used to monitor compliance with the exercise programme
Locations(1)
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NCT06345118