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

NCT ID: NCT06345118

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 2; Fall; Elderly Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Otago exercise program

Intervention Type: BEHAVIORAL

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Otago exercise program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

OEP

Eligibility Criteria

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 of falls according to the criteria of World Guidelines for Falls Prevention and Management for Older Adults - British Geriatric Society.

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, 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Geriatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dinh Trung Hoa

Endocrinologist Principal Investigator and Sponsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huyen TT Vu, PhD

Role: STUDY_CHAIR

National Geriatric Hospital

Locations

National Geriatric Hospital

Hanoi, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Hoa T Dinh, MD

Role: CONTACT

dinhtrunghoa95@gmail.com

+84858038888

Tam N Nguyen, PhD

Role: CONTACT

ngoctam@hmu.edu.vn

+84979221905

Facility Contacts

Huyen TT Vu, PhD

Role: primary

vuthanhhuyen11@yahoo.com

+84913531579

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Related Links

https://www.un.org/development/desa/pd/news/world-population-ageing-2020-highlights

United Nations Department of Economic and Social Affairs, Population Division. World Population Ageing 2020 Highlights

Other Identifiers

FallpreventT2DMelderly

Identifier Type: -

Identifier Source: org_study_id