Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus (FallT2DMOLD)

November 12, 2024 updated by: Dinh Trung Hoa, National Geriatric Hospital

.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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • National Geriatric Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: 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

Other Names:
  • OEP
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance 1 - Timed Up and Go (TUG)
Time Frame: Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)
To determine fall risk and measure the progress of balance, sit to stand and walking. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. Each group of patients will have different cut-off time value based on different studies
Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)
Physical performance 2 -Berg Balance Scale (BBS)
Time Frame: Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)

The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. Cut-off scores for the elderly were reported by Berg et al 1992:

A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke
Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of Daily Living (ADLs)
Time Frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best)
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
Health-related Quality of Life
Time Frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
Health-related Quality of Life is assessed using the health questionnaire 5-level 5 dimensions from EuroQol Group: index scores range from -0.59 to 1; 1 is the best possible health state.
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
Functional Reach Test (FRT)
Time Frame: Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)

Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in in simple task.

In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

This information is correlated with risk of falling. Measurement Interpretation: 10"/25 cm or greater: Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach: Risk of falling is 8x greater than normal
Prior to the start of intervention, reassess monthly at follow-up visits (1,2,3,4,5 month and 6th month - completion of intervention)
Instrumental Activities of Daily Living (IADLs)
Time Frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)
Lawton Instrumental Activities of Daily Living Scale (scores range from 0-low function & dependent to 8-high function & independent for women, and 0-worst to 5-best for men)
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Geriatric Hospital

Investigators

  • Study Chair: Huyen TT Vu, PhD, National Geriatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FallpreventT2DMelderly

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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