Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-60
SponsorNational Geriatric Hospital
About this trial
.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 criteria
This trial does not accept healthy volunteersQualifiers
Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria
HbA1c ≥ 7.0 and ≤ 9%
Age ≥ 60 and ≤ 80
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Otago exercise program
BehavioralThe 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
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
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)2
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
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)Secondary outcomes
1
Activities of Daily Living (ADLs)
Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best)
Time frame
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)2
Health-related Quality of Life
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.
Time frame
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)3
Functional Reach Test (FRT)
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
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)4
Instrumental Activities of Daily Living (IADLs)
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)
Time frame
Prior to the start of intervention (Week 0), following the completion of the intervention (Week 24)Sponsors and contacts
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Source ClinicalTrials.gov