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

NCT06345118 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Geriatric Hospital

    lead OTHER_GOV

Principal Investigators

  • Huyen TT Vu, PhD · National Geriatric Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2025-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06345118 on ClinicalTrials.gov