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Diabetes Mellitus, Type 2FallT2DMOLDNCT06345118

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

A study testing Otago exercise program in people with Diabetes Mellitus, Type 2 and Fall, run by National Geriatric Hospital at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 60 years
Conditions the study is for
Diabetes Mellitus, Type 2, Fall, Elderly Patient
What is being tested?
Otago exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteVietnam
Study dates
1 Mar 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hoa T Dinh, MD contact

+84858038888

dinhtrunghoa95@gmail.com

Tam N Nguyen, PhD contact

+84979221905

ngoctam@hmu.edu.vn

Vietnam1 site, 1 recruiting

  • National Geriatric Hospital

    Hanoi, 100000

    Huyen TT Vu, PhD, +84913531579, vuthanhhuyen11@yahoo.com

    Recruiting

Other trials in Vietnam

About this study

.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.
Read more

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.

Read the 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.

Being tested
Otago exercise program
Keywords
Falls prevention, Diabetes Mellitus type2, Elderly patient
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otago exercise programBehavioural

    Also called OEP

    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

Study groups in NCT06345118
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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
Receives: Behavioral: Otago exercise program
Control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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)

  1. Activities of Daily Living (ADLs)

    Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best)

    Measured: 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.

    Measured: 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

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345118
Sponsor's protocol ID
FallpreventT2DMelderly
Acronym
FallT2DMOLD
Status last verified
Nov 2024
First submitted
18 Mar 2024
Last updated
13 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.

    PubMed 22187472

  • O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.

    PubMed 25324330

  • Montero-Odasso MM, Kamkar N, Pieruccini-Faria F, Osman A, Sarquis-Adamson Y, Close J, Hogan DB, Hunter SW, Kenny RA, Lipsitz LA, Lord SR, Madden KM, Petrovic M, Ryg J, Speechley M, Sultana M, Tan MP, van der Velde N, Verghese J, Masud T; Task Force on Global Guidelines for Falls in Older Adults. Evaluation of Clinical Practice Guidelines on Fall Prevention and Management for Older Adults: A Systematic Review. JAMA Netw Open. 2021 Dec 1;4(12):e2138911. doi: 10.1001/jamanetworkopen.2021.38911.

    PubMed 34910151

  • 2019 surveillance of falls in older people: assessing risk and prevention (NICE guideline CG161) [Internet]. London: National Institute for Health and Care Excellence (NICE); 2019 May 23. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK551819/

    PubMed 31869045

  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PubMed 15111519

  • Lee PG, Halter JB. The Pathophysiology of Hyperglycemia in Older Adults: Clinical Considerations. Diabetes Care. 2017 Apr;40(4):444-452. doi: 10.2337/dc16-1732.

    PubMed 28325795

  • Chia CW, Egan JM, Ferrucci L. Age-Related Changes in Glucose Metabolism, Hyperglycemia, and Cardiovascular Risk. Circ Res. 2018 Sep 14;123(7):886-904. doi: 10.1161/CIRCRESAHA.118.312806.

    PubMed 30355075

  • American Diabetes Association Professional Practice Committee. 13. Older Adults: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S195-S207. doi: 10.2337/dc22-S013.

    PubMed 34964847

  • American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006.

    PubMed 33298417

  • Kosorok MR, Omenn GS, Diehr P, Koepsell TD, Patrick DL. Restricted activity days among older adults. Am J Public Health. 1992 Sep;82(9):1263-7. doi: 10.2105/ajph.82.9.1263.

    PubMed 1503169

  • Scaf-Klomp W, van Sonderen E, Sanderman R, Ormel J, Kempen GI. Recovery of physical function after limb injuries in independent older people living at home. Age Ageing. 2001 May;30(3):213-9. doi: 10.1093/ageing/30.3.213.

    PubMed 11443022

  • McInnes L, Gibbons E, Chandler-Oatts J. Clinical practice guideline for the assessment and prevention of falls in older people. Worldviews Evid Based Nurs. 2005;2(1):33-6. doi: 10.1111/j.1524-475X.2005.04094.x. No abstract available.

    PubMed 17040554

  • Ortega-Bastidas P, Gomez B, Aqueveque P, Luarte-Martinez S, Cano-de-la-Cuerda R. Instrumented Timed Up and Go Test (iTUG)-More Than Assessing Time to Predict Falls: A Systematic Review. Sensors (Basel). 2023 Mar 24;23(7):3426. doi: 10.3390/s23073426.

    PubMed 37050485

  • Williams B, Allen B, Hu Z, True H, Cho J, Harris A, Fell N, Sartipi M. Real-Time Fall Risk Assessment Using Functional Reach Test. Int J Telemed Appl. 2017;2017:2042974. doi: 10.1155/2017/2042974. Epub 2017 Jan 10.

    PubMed 28167961

  • Greenberg SA. How to try this: the Geriatric Depression Scale: Short Form. Am J Nurs. 2007 Oct;107(10):60-9; quiz 69-70. doi: 10.1097/01.NAJ.0000292204.52313.f3.

    PubMed 17895733

Questions about this trial

What is this clinical trial studying?

A study testing Otago exercise program in people with Diabetes Mellitus, Type 2 and Fall, run by National Geriatric Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hoa T Dinh, MD (+84858038888, dinhtrunghoa95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06345118, which also lists 65 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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