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

NCT06345118 | Recruiting

• 1 other identifier: FallpreventT2DMelderly
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Fall; Elderly Patient

Keywords

Falls prevention; Diabetes Mellitus type2; Elderly patient

Outcome Measures

Primary Outcomes (2)

• Physical performance 1 - Timed Up and Go (TUG)

  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)

  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 Outcomes (4)

• Activities of Daily Living (ADLs)

  Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)

• Health-related Quality of Life

  Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)

• Functional Reach Test (FRT)

  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)

  Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Otago exercise program 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

Also known as: OEP

Intervention group

Eligibility Criteria

• Age: 60 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Geriatric Hospital: lead

Study Sites (1)

National Geriatric Hospital

Hanoi, 100000, Vietnam

RECRUITING

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Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Huyen TT Vu, PhD

  National Geriatric Hospital

  STUDY CHAIR

Central Study Contacts

Hoa T Dinh, MD

CONTACT

+84858038888; dinhtrunghoa95@gmail.com

Tam N Nguyen, PhD

CONTACT

+84979221905; ngoctam@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist Principal Investigator and Sponsor

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 3, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

VN (1)