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Diabetes Mellitus Type 2NCT06819371

Impact of Dual vs. Single Task Exercise on Cognitive Function, Balance, and Functionality in Type 2 Diabetes

A study testing Single Task Exercise and Dual Task Exercise in people with Diabetes Mellitus Type 2, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Diabetes Mellitus is defined as a carbohydrate mechanism disorder in which glucose cannot be used as an adequate energy source and is produced excessively, causing hyperglycemia. For the diagnosis of diabetes, an increase in HbA1c in the blood or a high glucose concentration in venous plasma is examined. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Single Task Exercise and Dual Task Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Sep 2025to 15 Nov 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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having been diagnosed with T2DM,
  • Being between the ages of 40-65,
  • Being able to walk independently,
  • Being willing to exercise at least 2 days a week in the intervention groups as required by the research,
  • Not having cooperation and communication problems,
  • Not having participated in a regular exercise program in the last 6 months.

Who cannot join

  • Patients who do not volunteer to participate in the study
  • Patients with complications such as diabetes-related nephropathy, neuropathy, retinopathy
  • Patients with orthopedic, neurological, surgical problems that prevent them from walking and exercising
  • Patients with cardiac, pulmonary, or systemic diseases that prevent them from exercising
  • Patients with vision problems that cannot be corrected with glasses or lenses
  • Patients with hearing loss that cannot be corrected with hearing aids

Trial locations and contacts

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

Ferruh Taşpınar, Prof. Dr. contact

+905426853877

ferruh.taspinar@idu.edu.tr

Sidrenur Aslan Kolukısa, MSc Pt contact

Turkey (Türkiye)1 site
  • Izmir Democracy University

    Izmir

    Ferruh Taşpınar, Prof. Dr., +905426853877, ferruh.taspinar@idu.edu.tr

    Sidrenur Aslan Kolukısa, MSc Pt

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Dual Task and Single Task Exercise Training on Cognitive Performance, Balance and Functionality in Patients With Type 2 Diabetes

Diabetes Mellitus is defined as a carbohydrate mechanism disorder in which glucose cannot be used as an adequate energy source and is produced excessively, causing hyperglycemia. For the diagnosis of diabetes, an increase in HbA1c in the blood or a high glucose concentration in venous plasma is examined. Although there are various clinical subtypes, Type 2 diabetes constitutes 90% of the approximately 537 million diabetics worldwide. In the treatment of diabetes, there are pharmacological treatments and lifestyle changes to ensure glycemic control. The most important lifestyle change interventions are balanced calorie intake, increased physical activity and regular exercise.

The effect of exercise on complications associated with Type 2 diabetes, such as improving glycemic control, reducing inflammation and reducing cardiovascular risk, is clear and it is known that these also affect cognition.

In this context, dual-task exercises that can target both the improvement of parameters related to postural control and balance as a physical development and the development of cognitive functions are gaining importance. The aim of dual-task exercises is to direct the person's attention to another source while the first task is being performed. When the literature is examined, there are separate studies on the effects of dual-task exercises on both balance and walking performance and cognitive functions. However, the meta-analyses conducted on these studies emphasize the need for more newly designed studies. Therefore, our study aims to examine the effects of dual-task exercise training, which includes both physical and cognitive parameters, on cognitive functions, balance and functionality in individuals with type 2 diabetes. Patients who applied to the Artvin State Hospital Internal Medicine polyclinic and were diagnosed with type 2 diabetes and who meet the inclusion and exclusion criteria will be included in our study. The patients included in the study will be divided into 3 groups: dual-task exercise group, single-task exercise group and control group. Both intervention groups will be included in an exercise program with a physiotherapist 2 days a week for 8 weeks in addition to their medical treatments. The control group will be recommended walking only in addition to their medical treatment during these 8 weeks. All 3 groups will be evaluated twice, at the beginning of the study and at the end of the 8th week.

Read the detailed description

Diabetes Mellitus is defined as a carbohydrate mechanism disorder in which glucose cannot be used as an adequate energy source and is overproduced, causing hyperglycemia. Diabetes is diagnosed by an increase in HbA1c in the blood or a high glucose concentration in venous plasma. Although there are various clinical subtypes, Type 2 diabetes accounts for 90% of the approximately 537 million diabetics worldwide. In the treatment of diabetes, there are pharmacological treatments and lifestyle changes to achieve glycemic control. The most important lifestyle change interventions are balanced calorie intake, increased physical activity and regular exercise.

The effect of exercise on complications associated with Type 2 diabetes, such as improving glycemic control, reducing inflammation and reducing cardiovascular risk, is clear and is known to affect cognitive functions.

Loss of postural balance is a significant problem frequently observed in patients with T2DM. Balance is defined as the individual's capacity to maintain or regulate the center of mass within the limits of balance. In this process, the integration of physiological systems including motor, sensory and dynamic control systems, vestibular, visual and proprioceptive mechanisms, muscle strength and reaction times plays a critical role. Although balance dysfunctions are generally attributed to diabetic peripheral neuropathy (DPN), balance disorders are also observed in individuals without DPN. Impaired balance function increases the risk of falling, especially in elderly T2DM patients.

However, an important problem that is frequently observed in T2DM patients but can be neglected is cognitive dysfunction. Cognitive dysfunction is a broad concept that encompasses deficiencies in various areas such as attention, memory, executive functions, language and spatial skills. Diabetes and cognitive dysfunction are chronic conditions that are frequently seen together, especially in elderly individuals, and when evaluated together, they significantly increase the risk of morbidity and mortality. Cognitive impairment can lead to serious difficulties in meeting the self-care needs of diabetic individuals and maintaining their economic and social independence. On the other hand, inadequate management of diabetes can also increase the risk of cognitive dysfunction and cause this situation to worsen.

In this context, dual-task exercises that can target both the improvement of parameters related to postural control and balance as physical development and the development of cognitive functions are gaining importance. Therefore, our study aims to examine the effects of dual-task exercise training, which includes both physical and cognitive parameters, on cognitive functions, balance and functionality in individuals with type 2 diabetes.

Patients who apply to the Artvin State Hospital Internal Medicine polyclinic and are diagnosed with type 2 diabetes and meet the inclusion and exclusion criteria will be included in our study. The patients included in the study will be divided into 3 groups: dual-task exercise group, single-task exercise group and control group.

Each of the 3 groups will be evaluated twice, at the beginning of the study and at the end of the 8th week.

Being tested
Single Task Exercise, Dual Task Exercise
Keywords
Diabetes Mellitus Type 2, Dual task, Cognitive Function, Balance
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.

  • Single Task ExerciseOther

    Also called STE

    Patients will follow the exercises in a way to focus on only one task during the exercise sessions. In the creation of the exercise programme, the principles of the exercise prescription recommended by the American Sports Medicine Association for individuals with adult Type 2 diabetes will be taken into consideration. In this context, planning will be made by considering the progression of stretching, balance and walking exercises from simple to difficult.

  • Dual Task ExerciseOther

    Also called DTE

    Patients enrolled in the dual-task exercise group will perform a second task during the exercise sessions along with the exercises in the single-task exercise group. This second task will be determined individually according to the level and progress of the patient.

Study groups in NCT06819371
Study groupRoleWhat they receive
control groupNo interventionNo exercise will be applied. Patients will walk 60 minutes a week for 8 weeks
single task exercise groupExperimental12 participants will do balance exercises focusing on a single task for 8 weeks
Receives: Other: Single Task Exercise
dual task exercise groupExperimental12 participants will perform a simultaneous cognitive task in addition to balance exercise for 8 weeks
Receives: Other: Single Task Exercise; Other: Dual Task Exercise

What is being measured

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

  1. Timed get-up-and-go test (TUG)

    It is an easy-to-administer test used to evaluate the walking speed and functional mobility of the person. At the beginning of the test, the participant is seated in a chair. With the practitioner's start command, he/she gets up from the chair and walks 3 metres to the marked point and back. Then he sits back in the chair. The time is recorded during this performance. The test is repeated 3 times and the average of the times is determined as the person's Timed get up and walk test score .

    Measured: At baseline and after 8 weeks

  2. Four-step Square Test (FSST)

    This test is a tool used to test the dynamic aspect of balance and postural control during change of direction. To perform the test, 4 equal squares are marked on the floor with a stick, stick or tape. Each of the squares is numbered from 1 to 4 and the order of the numbers is taught to the patient. The person is asked to proceed to the square where he/she takes the first step (1), the square opposite (2), the square diagonally (3) and the back side square (4) in order. Then, he/she is instructed to go back to the starting point by moving in the opposite direction and a trial is made. They are instructed not to touch the field markings when completing this cycle. The completion time of the test is measured and the best time after 3 repetitions is recorded.

    Measured: At baseline and after 8 weeks

  3. Balance Error Scorring System (BESS)

    This test is used to assess the postural control of a person on different surfaces and in different postures. For the assessment, individuals are asked to maintain the two-foot on the ground, one-foot on the ground and tandem posture positions for 20 s on both stable and unstable ground, with eyes closed. During the test, 6 situations that are accepted as errors are indicated to the individuals in advance and the test is started after they make a trial for each posture. All test steps are recorded by video recording and 20 seconds are given for each position. The person's score is calculated on the basis of the number of errors made. In the interpretation of the test, there is an inverse relationship between the number of error points and postural control.

    Measured: At baseline and after 8 weeks

  4. Functional Reach Test (FRT)

    n this test, which is used to assess dynamic balance, the participant is asked to stand sideways in front of a flat wall and extend the arm on the wall side forwards with the shoulder flexed at 90 degrees and the elbow in extension. In this position, the 3rd metacarpal joint level of the hand is marked on the wall. The person is then asked to reach as far as he/she can reach forwards without flexing the knees and without taking a step. The distance between the first marked point and the reaching point is measured with a tape measure.

    Measured: At baseline and after 8 weeks

  5. Montreal Cognitive Assessment (MOCA)

    It has an application time of approximately 10 minutes with sections including orientation ability, attention, memory, language functions, visual spatial skills and executive function processes. The score range to be obtained from the scale is between 0 and 30 and a score above 21 is considered normal.

    Measured: At baseline and after 8 weeks

  6. Scoring Range

    The test consists of two stages as forward and backward number range. For both stages, number sequences are given to the person with one second intervals. The person is asked to say the numbers in the same order for the forward range and in reverse order for the backward range. If the person cannot repeat two consecutive number sequences, the previous number sequence is recorded as the score obtained.

    Measured: At baseline and after 8 weeks

  7. Stroop Test

    The aim of the Stroop test is to evaluate the person's speed of processing information, especially simple and complex attention, inhibition ability, ability to be resistant to interference. The test to be used in our study includes 3 steps: In the first step, the person is asked to say the colours of the boxes in the form, in the second step to read the words in the form quickly, and in the last step to say the colours of the words. The time taken to complete each step is noted. The time difference between steps 2 and 3, the error made and the self-correction scores are recorded.

    Measured: At baseline and after 8 weeks

  8. The Controlled Oral Word Association Test

    In this two-stage test, both semantic and phonemic fluency are measured in order to test the person's executive function skills such as verbal fluency, mental flexibility, information processing speed, inhibition and semantic organisation. In the first stage, the person is given 1 minute and asked to produce words in a certain category (animal names). In the second stage, the person is asked to produce words starting with the letters K, A, S in 1 minute periods.

    Measured: At baseline and after 8 weeks

Timeline

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

  1. First posted11 Feb 2025
  2. Study start10 Sep 2025 (estimated)
  3. Primary completion15 Oct 2025 (estimated)
  4. Study completion15 Nov 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
Model description
Randomized controlled study
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06819371
Sponsor's protocol ID
Dualtask
Status last verified
Aug 2025
First submitted
23 Jan 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Single Task Exercise and Dual Task Exercise in people with Diabetes Mellitus Type 2, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

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 6 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: opening soon, as of the sponsor's last update on 13 Aug 2025. 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 Turkey (Türkiye). 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 Ferruh Taşpınar, Prof. Dr. (+905426853877, ferruh.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed get-up-and-go test (TUG) (time frame: At baseline and after 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Aug 2025.

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