Diabetes Mellitus, Type 2NCT06721429
Dual-Task Versus Combined Exercise Training in Older Adults With Type 2 Diabetes
A study testing dual task exercise group and Combined Exercise Training Group in people with Diabetes Mellitus, Type 2, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study is to investigate the effects of dual-task training on functional mobility, exercise capacity, cognitive function, and quality of life in adults aged 65 years and older with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- dual task exercise group and Combined Exercise Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2024to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being followed up with a diagnosis of Type 2 Diabetes Mellitus for at least 6 months (fasting plasma glucose of 7.0 mmol/L or higher)
- Not having participated in any structured exercise program for at least 6 months prior.
- Being willing to volunteer for the study
Who cannot join
- Nephropathy
- Retinopathy
- Having dementia or Alzheimer's disease
- Using a walking aid
- Having ulceration
- Using balance-curing drugs
Show all 13Show fewer
- Surviving myocardial infarction at least 6 months ago
- Stable or unstable angina pectoris
- Left ventricular ejection fraction below 40%
- Peripheral arterial diseases
- Resting blood pressure above 160/100 mmHg
- Body mass index above 35 kg/m2
- Having a history of deep vein thrombosis, pulmonary embolism or stroke in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
The aim of this randomized controlled study is to investigate the effects of dual-task training on functional mobility, exercise capacity, cognitive function, and quality of life in adults aged 65 years and older with type 2 diabetes mellitus. Changes in serum brain-derived neurotrophic factor (BDNF) levels will also be assessed as a secondary outcome.
The study will compare three groups: dual-task training, combined exercise training, and a control group. Both exercise groups will receive aerobic, resistance, and balance training three times per week for eight weeks. In the dual-task group, participants will perform cognitive tasks targeting memory, verbal fluency, executive function, calculation, and attention concurrently with the physical exercises. The combined exercise group will perform the physical exercises without concurrent cognitive tasks.
The main research question is whether adding simultaneous cognitive tasks to combined exercise training provides additional benefits for functional mobility, assessed using the Timed Up and Go test. The study will also examine effects on exercise capacity, cognitive function, dual-task performance, quality of life, and serum BDNF levels. Outcomes will be compared across the three groups.
Read the detailed description
Older adults with type 2 diabetes mellitus (T2DM) may experience balance, gait, and cognitive impairments. T2DM is associated with an increased risk of cognitive decline and dementia in older adults. Factors such as insulin resistance, impaired glucose metabolism, advanced glycation end-products, impaired amyloid beta clearance, oxidative stress, and inflammation may contribute to these changes. T2DM has been linked to impairments in episodic memory, verbal fluency, working memory, processing speed, and executive functions. Executive functions are higher-level processes that oversee and regulate other cognitive functions. These capabilities support planning, decision-making, switching between tasks, goal-directed behavior, and coordinating simultaneous activities. Executive function also contributes to the integration of sensory information required for balance and gait. Impairments in these functions may therefore compromise functional mobility and increase fall risk in older adults with T2DM.
Dual-task paradigms are used to examine performance when two tasks are undertaken simultaneously. A primary motor task, such as walking, is combined with a secondary task, and the effects on performance are evaluated. Everyday activities, such as walking while talking, frequently involve these simultaneous demands. When the combined demands of the tasks exceed available attentional resources, performance on one or both tasks may deteriorate. Executive dysfunction may increase this interference. Dual tasks can involve motor-cognitive, cognitive-cognitive, or motor-motor combinations. Previous research has reported adverse effects of dual-task conditions on gait parameters in individuals with T2DM. These findings highlight the importance of considering the interaction between cognitive abilities and motor skills when planning rehabilitation programs.
The effects of dual-task training on balance and cognitive function have been investigated in other populations at increased risk of falls, including stroke survivors, individuals with Parkinson's disease, and older adults with a history of falls. Because cognitive processes contribute to balance and mobility, evaluating physical performance together with cognitive function may provide a more comprehensive understanding of the effects of dual-task training. Previous studies have reported improvements in balance and executive function following dual-task training in older adults. Combined aerobic and resistance exercise has also shown potential benefits for cognition in individuals with T2DM. However, whether adding concurrent cognitive tasks to a combined exercise program provides additional benefits in older adults with T2DM remains unclear.
Brain-derived neurotrophic factor (BDNF) is involved in synaptic plasticity and may provide a biological link between exercise and cognitive function. Nevertheless, reported BDNF responses to exercise in individuals with T2DM have been variable. Assessing serum BDNF alongside functional and cognitive outcomes may help characterize the responses to combined physical and cognitive training, although serum measurements alone cannot establish changes in brain function.
This three-arm randomized controlled study will investigate the effects of dual-task training compared with combined exercise training and a control condition in adults aged 65 years and older with T2DM. Participants will be randomly assigned to the dual-task training group, the combined exercise training group, or the control group. Both exercise groups will undergo aerobic, resistance, and balance training three times per week for eight weeks. The dual-task group will perform the same physical exercise program with concurrent cognitive tasks targeting memory, verbal fluency, executive function, mental arithmetic, and divided attention. The combined exercise group will perform the physical exercises without concurrent cognitive tasks. The control group will receive standardized education on physical activity, glycemic self-monitoring, and reducing sedentary behavior, with weekly telephone contact.
The study will examine whether adding concurrent cognitive tasks to combined exercise training provides additional benefits for functional mobility, assessed using the Timed Up and Go test. Exercise capacity, global cognitive function, executive function, reaction time, dual-task mobility and cost, diabetes-specific quality of life, and serum BDNF levels will also be evaluated before and after the intervention. The study aims to clarify the potential contribution of concurrent cognitive training to rehabilitation in older adults with T2DM.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- dual task exercise group, Combined Exercise Training Group
- Keywords
- exercise, balance, exercise tolerance, Mental Status
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual task exercise groupOther
Dual task exercise group Patients in the dual-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attentioN Single task exercise group Patients in the single-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.
Combined Exercise Training GroupOther
Combined Exercise Training Group Patients in the single-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.
| Study group | Role | What they receive |
|---|---|---|
| dual task exercise group | Experimental | Patients in the dual-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attention. Receives: Other: dual task exercise group |
| Combined Exercise Training Group | Active comparator | Patients in the single-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. Receives: Other: Combined Exercise Training Group |
| control group | No intervention | Participants in the control group will be instructed to continue their usual daily activities without participating in a structured exercise training program during the eight-week study period. They will receive standardized education on physical activity, blood glucose self-monitoring, and reducing sedentary behavior, with weekly telephone contact. After the final assessment, participants will be invited to join an exercise training program of their choice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go Test
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
Measured: Baseline and immediately after the eight-week intervention.
Secondary outcomes (7)
Functional exercise capacity Functional Exercise Capacity
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT). The participants will be instructed to walk at their maximum comfortable pace for 6 minutes along a 30-meter long, flat, and uninterrupted corridor. At the end of the test, the endpoint will be marked, and the total distance walked will be calculated.
Measured: Baseline and immediately after the eight-week intervention.
Timed Up and Go Test (Cognitive)
Participants will be asked to perform both the single-task and cognitive dual-task versions of the Timed Up and Go (TUG) test. In the single-task condition, participants will complete the TUG test without any secondary task. In the cognitive dual-task condition, participants will perform the TUG test while also engaging in a cognitive task, specifically subtracting 3 from 100 repeatedly during the walk.
Measured: Baseline and immediately after the eight-week intervention.
Montreal Cognitive Assessment (MoCA)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a reliable assessment tool that is particularly effective in testing cognitive levels in individuals with mild cognitive impairment and Alzheimer's disease. It is designed to evaluate various cognitive domains, including attention, memory, language, visuospatial abilities, executive functions, and orientation, providing a comprehensive measure of cognitive health. This tool is widely used in clinical settings for early detection and monitoring of cognitive decline.
Measured: Baseline and immediately after the eight-week intervention.
Stroop Test
The Stroop Test is a widely used psychological test to assess cognitive flexibility, selective attention, and the ability to inhibit cognitive interference. The test is based on the Stroop Effect, which refers to the delay in reaction time when the name of a color is written in a different color ink.
Measured: Baseline and immediately after the eight-week intervention.
Diabetes-specific Quality of Life Scale (ADDQoL)
Diabetes-specific quality of life will be assessed using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire. Two global items and the average weighted impact score will be evaluated to assess the perceived impact of diabetes on quality of life.
Measured: Baseline and immediately after the eight-week intervention.
Processing Speed
The processing speed will be evaluated by measuring the reaction time. To measure the reaction time, a FitLight Trainer (Fitlight Sports Corp., Canada) will be used. The FitLight Trainer is primarily used for training purposes and is also suitable for use with older individuals.
Measured: Baseline and immediately after the eight-week intervention.
Biochemical Analysis
Baseline HbA1c levels will be reported to characterize glycemic status. Serum BDNF levels will be assessed before and after the eight-week intervention.
Measured: Baseline and immediately after the eight-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Dec 2024
- Primary completion30 Nov 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This study will include 36 adults aged 65 years or older with type 2 diabetes mellitus. Eligible participants will be randomly assigned to one of three groups: dual-task training (n=12), combined exercise training (n=12), or control (n=12). Both exercise groups will receive the same physical exercise program comprising aerobic, resistance, and balance training. Participants in the combined exercise training group will perform these exercises without concurrent cognitive tasks, whereas those in the dual-task training group will perform the same exercises while simultaneously completing cognitive tasks targeting memory, verbal fluency, executive function, mental arithmetic, and divided attention. The control group will receive standardized education on physical activity, blood glucose self-monitoring, and reducing sedentary behavior, with weekly telephone contact. The exercise program will be delivered three times per week on non-consecutive days for eight weeks, comprising 24 sessions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gizem Mermerkaya, Bartın Unıversity
- Investigators
- gizem mermerkaya, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721429
- Sponsor's protocol ID
- BARU-FTR-GM-02
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villafaina S, Collado-Mateo D, Dominguez-Munoz FJ, Fuentes-Garcia JP, Gusi N. Impact of adding a cognitive task while performing physical fitness tests in women with fibromyalgia: A cross-sectional descriptive study. Medicine (Baltimore). 2018 Dec;97(51):e13791. doi: 10.1097/MD.0000000000013791.
PubMed 30572536Shellington EM, Reichert SM, Heath M, Gill DP, Shigematsu R, Petrella RJ. Results From a Feasibility Study of Square-Stepping Exercise in Older Adults With Type 2 Diabetes and Self-Reported Cognitive Complaints to Improve Global Cognitive Functioning. Can J Diabetes. 2018 Dec;42(6):603-612.e1. doi: 10.1016/j.jcjd.2018.02.003. Epub 2018 Mar 6.
PubMed 29884522Beauchet O, Dubost V, Aminian K, Gonthier R, Kressig RW. Dual-task-related gait changes in the elderly: does the type of cognitive task matter? J Mot Behav. 2005 Jul;37(4):259-64.
PubMed 15967751Tard C, Dujardin K, Girard A, Debaughrien M, Derambure P, Defebvre L, Delval A. How does visuospatial attention modulate motor preparation during gait initiation? Exp Brain Res. 2016 Jan;234(1):39-50. doi: 10.1007/s00221-015-4436-0. Epub 2015 Sep 10.
PubMed 26358126Park JH. Is Dual-Task Training Clinically Beneficial to Improve Balance and Executive Function in Community-Dwelling Older Adults with a History of Falls? Int J Environ Res Public Health. 2022 Aug 17;19(16):10198. doi: 10.3390/ijerph191610198.
PubMed 36011833Zhang J, Tam WWS, Hounsri K, Kusuyama J, Wu VX. Effectiveness of Combined Aerobic and Resistance Exercise on Cognition, Metabolic Health, Physical Function, and Health-related Quality of Life in Middle-aged and Older Adults With Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Aug;105(8):1585-1599. doi: 10.1016/j.apmr.2023.10.005. Epub 2023 Oct 22.
PubMed 37875170Callisaya ML, Daly RM, Sharman JE, Bruce D, Davis TME, Greenaway T, Nolan M, Beare R, Schultz MG, Phan T, Blizzard LC, Srikanth VK. Feasibility of a multi-modal exercise program on cognition in older adults with Type 2 diabetes - a pilot randomised controlled trial. BMC Geriatr. 2017 Oct 16;17(1):237. doi: 10.1186/s12877-017-0635-9.
PubMed 29037162
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06721429
- Acronym / sponsor ID
- BARU-FTR-GM-02
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- exercise, balance, exercise tolerance, Mental Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled study is to investigate the effects of dual-task training on functional mobility, exercise capacity, cognitive function, and quality of life in adults aged 65 years and older with type 2 diabetes mellitus. Changes in serum brain-derived neurotrophic factor (BDNF) levels will also be assessed as a secondary outcome.
The study will compare three groups: dual-task training, combined exercise training, and a control group. Both exercise groups will receive aerobic, resistance, and balance training three times per week for eight weeks. In the dual-task group, participants will perform cognitive tasks targeting memory, verbal fluency, executive function, calculation, and attention concurrently with the physical exercises. The combined exercise group will perform the physical exercises without concurrent cognitive tasks.
The main research question is whether adding simultaneous cognitive tasks to combined exercise training provides additional benefits for functional mobility, assessed using the Timed Up and Go test. The study will also examine effects on exercise capacity, cognitive function, dual-task performance, quality of life, and serum BDNF levels. Outcomes will be compared across the three groups.
Detailed description
Older adults with type 2 diabetes mellitus (T2DM) may experience balance, gait, and cognitive impairments. T2DM is associated with an increased risk of cognitive decline and dementia in older adults. Factors such as insulin resistance, impaired glucose metabolism, advanced glycation end-products, impaired amyloid beta clearance, oxidative stress, and inflammation may contribute to these changes. T2DM has been linked to impairments in episodic memory, verbal fluency, working memory, processing speed, and executive functions. Executive functions are higher-level processes that oversee and regulate other cognitive functions. These capabilities support planning, decision-making, switching between tasks, goal-directed behavior, and coordinating simultaneous activities. Executive function also contributes to the integration of sensory information required for balance and gait. Impairments in these functions may therefore compromise functional mobility and increase fall risk in older adults with T2DM.
Dual-task paradigms are used to examine performance when two tasks are undertaken simultaneously. A primary motor task, such as walking, is combined with a secondary task, and the effects on performance are evaluated. Everyday activities, such as walking while talking, frequently involve these simultaneous demands. When the combined demands of the tasks exceed available attentional resources, performance on one or both tasks may deteriorate. Executive dysfunction may increase this interference. Dual tasks can involve motor-cognitive, cognitive-cognitive, or motor-motor combinations. Previous research has reported adverse effects of dual-task conditions on gait parameters in individuals with T2DM. These findings highlight the importance of considering the interaction between cognitive abilities and motor skills when planning rehabilitation programs.
The effects of dual-task training on balance and cognitive function have been investigated in other populations at increased risk of falls, including stroke survivors, individuals with Parkinson's disease, and older adults with a history of falls. Because cognitive processes contribute to balance and mobility, evaluating physical performance together with cognitive function may provide a more comprehensive understanding of the effects of dual-task training. Previous studies have reported improvements in balance and executive function following dual-task training in older adults. Combined aerobic and resistance exercise has also shown potential benefits for cognition in individuals with T2DM. However, whether adding concurrent cognitive tasks to a combined exercise program provides additional benefits in older adults with T2DM remains unclear.
Brain-derived neurotrophic factor (BDNF) is involved in synaptic plasticity and may provide a biological link between exercise and cognitive function. Nevertheless, reported BDNF responses to exercise in individuals with T2DM have been variable. Assessing serum BDNF alongside functional and cognitive outcomes may help characterize the responses to combined physical and cognitive training, although serum measurements alone cannot establish changes in brain function.
This three-arm randomized controlled study will investigate the effects of dual-task training compared with combined exercise training and a control condition in adults aged 65 years and older with T2DM. Participants will be randomly assigned to the dual-task training group, the combined exercise training group, or the control group. Both exercise groups will undergo aerobic, resistance, and balance training three times per week for eight weeks. The dual-task group will perform the same physical exercise program with concurrent cognitive tasks targeting memory, verbal fluency, executive function, mental arithmetic, and divided attention. The combined exercise group will perform the physical exercises without concurrent cognitive tasks. The control group will receive standardized education on physical activity, glycemic self-monitoring, and reducing sedentary behavior, with weekly telephone contact.
The study will examine whether adding concurrent cognitive tasks to combined exercise training provides additional benefits for functional mobility, assessed using the Timed Up and Go test. Exercise capacity, global cognitive function, executive function, reaction time, dual-task mobility and cost, diabetes-specific quality of life, and serum BDNF levels will also be evaluated before and after the intervention. The study aims to clarify the potential contribution of concurrent cognitive training to rehabilitation in older adults with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study will include 36 adults aged 65 years or older with type 2 diabetes mellitus. Eligible participants will be randomly assigned to one of three groups: dual-task training (n=12), combined exercise training (n=12), or control (n=12). Both exercise groups will receive the same physical exercise program comprising aerobic, resistance, and balance training. Participants in the combined exercise training group will perform these exercises without concurrent cognitive tasks, whereas those in the dual-task training group will perform the same exercises while simultaneously completing cognitive tasks targeting memory, verbal fluency, executive function, mental arithmetic, and divided attention. The control group will receive standardized education on physical activity, blood glucose self-monitoring, and reducing sedentary behavior, with weekly telephone contact. The exercise program will be delivered three times per week on non-consecutive days for eight weeks, comprising 24 sessions.
| Arm | Type | Receives |
|---|---|---|
| dual task exercise group | Experimental | Other: dual task exercise groupPatients in the dual-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attention. |
| Combined Exercise Training Group | Active comparator | Other: Combined Exercise Training GroupPatients in the single-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. |
| control group | No intervention | –Participants in the control group will be instructed to continue their usual daily activities without participating in a structured exercise training program during the eight-week study period. They will receive standardized education on physical activity, blood glucose self-monitoring, and reducing sedentary behavior, with weekly telephone contact. After the final assessment, participants will be invited to join an exercise training program of their choice. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being followed up with a diagnosis of Type 2 Diabetes Mellitus for at least 6 months (fasting plasma glucose of 7.0 mmol/L or higher)
- Not having participated in any structured exercise program for at least 6 months prior.
- Being willing to volunteer for the study
Key exclusion criteria (13 listed)
- Nephropathy
- Retinopathy
- Having dementia or Alzheimer's disease
- Using a walking aid
- Having ulceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual task exercise groupDual task exercise group Patients in the dual-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attentioN Single task exercise group Patients in the single-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. | Other | dual task exercise group |
| Combined Exercise Training GroupCombined Exercise Training Group Patients in the single-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. | Other | Combined Exercise Training Group |
Primary outcome
Time Up and Go Test
Time frame: Baseline and immediately after the eight-week intervention.
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
7 secondary outcomes
Functional exercise capacity Functional Exercise Capacity
Time frame: Baseline and immediately after the eight-week intervention.
Timed Up and Go Test (Cognitive)
Time frame: Baseline and immediately after the eight-week intervention.
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and immediately after the eight-week intervention.
Stroop Test
Time frame: Baseline and immediately after the eight-week intervention.
Diabetes-specific Quality of Life Scale (ADDQoL)
Time frame: Baseline and immediately after the eight-week intervention.
Processing Speed
Time frame: Baseline and immediately after the eight-week intervention.
Biochemical Analysis
Time frame: Baseline and immediately after the eight-week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 30572536Villafaina S, Collado-Mateo D, Dominguez-Munoz FJ, Fuentes-Garcia JP, Gusi N. Impact of adding a cognitive task while performing physical fitness tests in women with fibromyalgia: A cross-sectional descriptive study. Medicine (Baltimore). 2018 Dec;97(51):e13791. doi: 10.1097/MD.0000000000013791.
- Background: PubMed 29884522Shellington EM, Reichert SM, Heath M, Gill DP, Shigematsu R, Petrella RJ. Results From a Feasibility Study of Square-Stepping Exercise in Older Adults With Type 2 Diabetes and Self-Reported Cognitive Complaints to Improve Global Cognitive Functioning. Can J Diabetes. 2018 Dec;42(6):603-612.e1. doi: 10.1016/j.jcjd.2018.02.003. Epub 2018 Mar 6.
- Background: PubMed 15967751Beauchet O, Dubost V, Aminian K, Gonthier R, Kressig RW. Dual-task-related gait changes in the elderly: does the type of cognitive task matter? J Mot Behav. 2005 Jul;37(4):259-64.
- Background: PubMed 26358126Tard C, Dujardin K, Girard A, Debaughrien M, Derambure P, Defebvre L, Delval A. How does visuospatial attention modulate motor preparation during gait initiation? Exp Brain Res. 2016 Jan;234(1):39-50. doi: 10.1007/s00221-015-4436-0. Epub 2015 Sep 10.
- Background: PubMed 36011833Park JH. Is Dual-Task Training Clinically Beneficial to Improve Balance and Executive Function in Community-Dwelling Older Adults with a History of Falls? Int J Environ Res Public Health. 2022 Aug 17;19(16):10198. doi: 10.3390/ijerph191610198.
- Background: PubMed 37875170Zhang J, Tam WWS, Hounsri K, Kusuyama J, Wu VX. Effectiveness of Combined Aerobic and Resistance Exercise on Cognition, Metabolic Health, Physical Function, and Health-related Quality of Life in Middle-aged and Older Adults With Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Aug;105(8):1585-1599. doi: 10.1016/j.apmr.2023.10.005. Epub 2023 Oct 22.
- Background: PubMed 29037162Callisaya ML, Daly RM, Sharman JE, Bruce D, Davis TME, Greenaway T, Nolan M, Beare R, Schultz MG, Phan T, Blizzard LC, Srikanth VK. Feasibility of a multi-modal exercise program on cognition in older adults with Type 2 diabetes - a pilot randomised controlled trial. BMC Geriatr. 2017 Oct 16;17(1):237. doi: 10.1186/s12877-017-0635-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gizem mermerkaya principal investigator
Bartın Unıversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual task exercise group and Combined Exercise Training Group in people with Diabetes Mellitus, Type 2, run by Bartın Unıversity 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 22 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Up and Go Test (time frame: Baseline and immediately after the eight-week intervention.). 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 NCT06721429, which also lists 7 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 22 Sep 2026.