Diabetes Mellitus, Type 2COGWALK-T2DNCT07920510
Effects of Individualized Preferred and Higher Treadmill Walking Speeds Followed by Cognitive Training on Heart Rate Variability, Gait Performance, and Motor-Cognitive Function in Older Adults With Type 2 Diabetes: A Randomized Controlled Trial With 4-Week Retention Follow-up
A study testing Individualized Higher-Speed Treadmill Walking, Individualized Preferred-Speed Treadmill Walking and Cognitive training in people with Diabetes Mellitus, Type 2, run by University of Phayao at 1 site in Thailand.
Trial summary
This randomized controlled trial evaluates the effects of two individualized treadmill walking speeds followed by cognitive training in older adults with type 2 diabetes. Participants are assigned to one of three groups: treadmill walking at 100% of preferred walking speed (PWS) followed by cognitive training… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Individualized Higher-Speed Treadmill Walking, Individualized Preferred-Speed Treadmill Walking and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 22 Apr 2026to 29 Oct 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults aged 60 years or older.
- Physician-diagnosed type 2 diabetes mellitus for at least 1 year.
- Low to moderate physical activity level as assessed using the Global Physical Activity Questionnaire (GPAQ), with total physical activity below 3,000 MET-minutes/week or not meeting the WHO criteria for a high physical activity level.
- Able to walk independently without an assistive walking device and able to walk safely on a treadmill.
- Normal or corrected vision and hearing sufficient to follow study instructions and complete the assessments.
Who cannot join
- Unstable cardiovascular disease, including uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled resting hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
- Severe musculoskeletal problems that may limit safe treadmill walking, including severe knee or hip osteoarthritis (grade 3-4), knee or hip replacement surgery within the previous 6 months, or structural foot abnormalities that interfere with walking.
- Neurological conditions that may affect safe walking or balance, including a history of stroke, Parkinson's disease, or vestibular disorders.
- Severe diabetes-related complications, including diabetic foot ulcer or severe peripheral neuropathy with marked loss of foot sensation.
- Current use of medications that substantially affect the central nervous system, balance, or cause clinically relevant drowsiness.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial evaluates the effects of two individualized treadmill walking speeds followed by cognitive training in older adults with type 2 diabetes. Participants are assigned to one of three groups: treadmill walking at 100% of preferred walking speed (PWS) followed by cognitive training, treadmill walking at 120-130% of PWS followed by the same cognitive training, or a usual-activity control group.
The two exercise groups complete supervised training three times per week for 6 weeks. Cognitive training is performed after treadmill walking rather than simultaneously with walking for safety. The study evaluates heart rate variability, walking and functional performance, and motor-cognitive function. Outcomes are assessed before training, after the 6-week intervention, and again following a 4-week retention period.
Read the detailed description
This study is a three-arm, parallel-group randomized controlled trial designed to compare the effects of individualized treadmill walking at preferred and higher walking speeds when followed by cognitive training in older adults with type 2 diabetes.
Preferred walking speed (PWS) is determined individually before allocation. Participants assigned to the preferred-speed treadmill group perform supervised treadmill walking at 100% PWS throughout the intervention. Participants assigned to the higher-speed treadmill group perform supervised treadmill walking at 120-130% PWS. Both treadmill groups receive the same cognitive training following completion of the treadmill walking component. The cognitive tasks are performed separately from treadmill walking rather than concurrently to reduce the risk of loss of balance or falls during training.
Training is conducted three times per week for 6 weeks. Participants assigned to the control group continue their usual daily activities, with walking activity monitored using a pedometer, and receive fall-prevention health education without structured treadmill or cognitive training.
Following the 6-week intervention, supervised treadmill and cognitive training are discontinued. Participants are reassessed after a 4-week retention period. The study is designed to determine whether the two treadmill-speed prescriptions produce different responses in cardiac autonomic modulation, gait and functional performance, and motor-cognitive function, and whether observed changes are maintained after cessation of supervised training.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Individualized Higher-Speed Treadmill Walking, Individualized Preferred-Speed Treadmill Walking, Cognitive training, Fall-Prevention Health Education
- Keywords
- Older Adults, Treadmill Walking, Preferred Walking Speed, Higher-Speed Walking, Heart Rate Variability, Cognitive Training, Gait Performance, Motor-Cognitive Function, Functional Mobility, Retention Effects
- 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.
Individualized Higher-Speed Treadmill WalkingBehavioural
Participants perform supervised treadmill walking at an individualized speed prescribed relative to their preferred walking speed (PWS). The training speed is progressed from 120% to 130% of PWS during the 6-week intervention. Training is performed three sessions per week. Treadmill walking and cognitive training are performed sequentially rather than simultaneously for safety reasons. After completion of the 6-week intervention, no supervised treadmill training is provided during the 4-week retention period.
Individualized Preferred-Speed Treadmill WalkingBehavioural
Participants perform supervised treadmill walking at 100% of their individualized preferred walking speed (PWS) throughout the 6-week intervention. Training is performed three sessions per week. Treadmill walking and cognitive training are performed sequentially rather than simultaneously. After completion of the 6-week intervention, no supervised treadmill training is provided during the 4-week retention period.
Cognitive trainingBehavioural
Following completion of each treadmill walking session, participants perform a separate seated cognitive training session. Cognitive exercises include tasks such as backward counting and serial subtraction. Cognitive training is not performed concurrently with treadmill walking because simultaneous motor-cognitive task performance may increase fall risk in older adults. The same cognitive training protocol is provided to both treadmill-training groups during the 6-week intervention.
Fall-Prevention Health EducationBehavioural
Participants receive standardized educational material on fall prevention and continue their usual daily activities throughout the study period. No supervised treadmill walking or cognitive training is provided.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Experimental: Higher-Speed Treadmill Walking + Cognitive Training | Experimental | Participants perform individualized treadmill walking prescribed relative to their baseline preferred walking speed (PWS), using 120-130% PWS as the higher-speed condition. Treadmill walking is performed under supervision three times per week for 6 weeks. After completion of the treadmill walking component, participants perform a separate seated cognitive training session. Cognitive training is not performed concurrently with treadmill walking because of safety considerations related to fall risk in older adults. After the 6-week intervention, participants receive no supervised treadmill or cognitive training for 4 weeks before the retention assessment. Receives: Behavioral: Individualized Higher-Speed Treadmill Walking; Behavioral: Cognitive training |
| Arm 2 - Active Comparator: Preferred-Speed Treadmill Walking + Cognitive Training | Active comparator | Participants perform individualized treadmill walking at 100% of their baseline preferred walking speed (PWS) under supervision three times per week for 6 weeks. After completion of treadmill walking, participants perform the same separate seated cognitive training used in the higher-speed group. Cognitive training is not performed concurrently with treadmill walking. After the 6-week intervention, participants receive no supervised treadmill or cognitive training for 4 weeks before the retention assessment. Receives: Behavioral: Individualized Preferred-Speed Treadmill Walking; Behavioral: Cognitive training |
| Arm 3 - Active Comparator: Usual Activity and Fall-Prevention Health Education | Active comparator | Participants continue their usual daily activities and do not receive supervised treadmill walking or cognitive training. Participants receive standardized health education on fall prevention. Outcomes are assessed according to the same schedule as the two treadmill-training groups. Receives: Behavioral: Fall-Prevention Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
Resting heart rate variability is assessed using the SA-3000P heart rate variability analyzer under standardized seated resting conditions. SDNN is the standard deviation of normal-to-normal R-R intervals and is reported in milliseconds (ms). Higher SDNN values indicate greater overall heart rate variability.
Measured: Baseline and immediately after the 6-week intervention.
Change in Root Mean Square of Successive Differences (RMSSD)
Resting heart rate variability is assessed using the SA-3000P heart rate variability analyzer under standardized seated resting conditions. RMSSD is calculated from successive normal-to-normal R-R interval differences and is reported in milliseconds (ms). RMSSD is used as an index of short-term cardiac vagal modulation.
Measured: Baseline and immediately after the 6-week intervention.
Change in Timed Up and Go Dual-Task Test Completion Time
Motor-cognitive mobility is assessed using the Timed Up and Go Test performed under a concurrent secondary-task condition. Participants rise from a chair, walk 3 meters, turn, return, and sit down while carrying a cup of water. Completion time is recorded in seconds. A shorter completion time indicates better performance under dual-task conditions.
Measured: Baseline and immediately after the 6-week intervention.
Change in Figure-of-8 Walk Dual-Task Test Completion Time
Dual-task walking performance is assessed using the Figure-of-8 Walk Test under a concurrent secondary-task condition. Participants walk a figure-of-8 course around two markers while carrying a cup of water. Completion time is recorded in seconds. A shorter completion time indicates better performance.
Measured: Baseline and immediately after the 6-week intervention.
Secondary outcomes (15)
Retention of SDNN Following Training Cessation
Resting SDNN is assessed using the SA-3000P heart rate variability analyzer to determine whether changes observed following treadmill walking and cognitive training are maintained after cessation of supervised training. SDNN is reported in milliseconds (ms).
Measured: 4 weeks after completion of the 6-week intervention (Week 10 from baseline).
Retention of RMSSD Following Training Cessation
Resting RMSSD is assessed using the SA-3000P heart rate variability analyzer to determine retention of cardiac autonomic adaptations after cessation of supervised training. RMSSD is reported in milliseconds (ms).
Measured: 4 weeks after completion of the 6-week intervention (Week 10 from baseline).
Change in 10-Meter Walk Test at Preferred Walking Pace
Walking performance is assessed using the 10-Meter Walk Test at the participant's preferred walking pace. Participants walk along a standardized level walkway, and walking performance is recorded as completion time in seconds. A shorter completion time indicates faster walking performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in 10-Meter Walk Test at Fast Walking Pace
Fast walking performance is assessed using the 10-Meter Walk Test. Participants are instructed to walk as fast as safely possible. Completion time is recorded in seconds. A shorter completion time indicates better fast-walking performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Five Times Sit-to-Stand Test
Functional lower-extremity performance is assessed using the Five Times Sit-to-Stand Test. Participants rise from and return to a seated position five consecutive times as quickly and safely as possible. Completion time is recorded in seconds. A shorter time indicates better functional performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Timed Up and Go Test
Functional mobility and dynamic balance are assessed using the Timed Up and Go Test. Participants stand from a chair, walk 3 meters, turn, return, and sit down. Completion time is recorded in seconds. A shorter completion time indicates better mobility.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Figure-of-8 Walk Test
Curved-path walking and dynamic balance are assessed using the Figure-of-8 Walk Test. Participants complete one figure-of-8 walking course around two markers positioned 1.5 meters apart. Completion time is recorded in seconds, with shorter values indicating better performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Stepping Trail-Making Test
Motor-cognitive performance is assessed using the Stepping Trail-Making Test. Participants step sequentially on numbered targets from 1 to 16 as quickly and accurately as possible. Completion time, including time required to correct errors, is recorded in seconds. A shorter completion time indicates better motor-cognitive performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in High-Frequency Normalized Power (HFnu)
High-frequency normalized power is obtained from resting heart rate variability analysis using the SA-3000P. HFnu represents the relative contribution of high-frequency power to the analyzed frequency-domain spectrum and is reported in normalized units.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Low-Frequency Normalized Power (LFnu)
Low-frequency normalized power is obtained from resting heart rate variability analysis using the SA-3000P and is reported in normalized units.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Low-Frequency to High-Frequency Power Ratio (LF/HF)
The LF/HF ratio is derived from frequency-domain heart rate variability analysis using the SA-3000P. The ratio is reported as a dimensionless HRV index and will be interpreted as an exploratory frequency-domain measure rather than as a direct measure of sympathovagal balance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in 2-Minute Step Test Performance
Functional aerobic endurance is assessed using the 2-Minute Step Test. Participants perform repeated stepping in place for 2 minutes, raising the knees to the standardized target height. The total number of completed steps is recorded. A higher number of steps indicates better functional endurance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Stroop Test Performance
Cognitive performance, particularly attention, inhibitory control, and executive function, is assessed using the Stroop Test. Performance is recorded according to the standardized scoring procedure used in the study. Higher scores indicate better cognitive performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Right-Hand Ruler Drop Test Performance
Simple visuomotor reaction performance is assessed using the Ruler Drop Test with the right hand. A ruler is released without warning and the participant attempts to catch it as quickly as possible. The distance fallen before the ruler is caught is recorded in centimeters. A shorter distance indicates faster reaction performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Left-Hand Ruler Drop Test Performance
Simple visuomotor reaction performance is assessed using the Ruler Drop Test with the left hand. A ruler is released without warning and the participant attempts to catch it as quickly as possible. The distance fallen before the ruler is caught is recorded in centimeters. A shorter distance indicates faster reaction performance.
Measured: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start22 Apr 2026
- Primary completion30 Aug 2026
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 is a three-arm, parallel-group randomized controlled trial in older adults with type 2 diabetes. Participants are randomized to: (1) individualized higher-speed treadmill walking at 120-130% of preferred walking speed (PWS) followed by cognitive training; (2) individualized treadmill walking at 100% PWS followed by the same cognitive training; or (3) a control condition consisting of usual daily activities with step monitoring and fall-prevention health education. The intervention is performed three times per week for 6 weeks. Following completion of the intervention, participants enter a 4-week retention period without supervised treadmill or cognitive training. The final retention assessment is performed 4 weeks after completion of training (Week 10 from baseline).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Phayao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chonticha Kaewjoho, University of Phayao
- Investigators
- Chonticha Kaewjoho, PT, PhD, Principal investigator, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920510
- Sponsor's protocol ID
- UPhayaoChonticha-222
- Other IDs
- HREC-UP-HSST 1.3/017/69
- Acronym
- COGWALK-T2D
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Preferred and Higher Treadmill Walking Speeds Followed by Cognitive Training on Heart Rate Variability, Gait Performance, and Motor-Cognitive Function in Older Adults With Type 2 Diabetes: A Randomized Controlled Trial With 4-Week Retention Follow-up
- ClinicalTrials.gov ID
- NCT07920510
- Acronym / sponsor ID
- COGWALK-T2D / UPhayaoChonticha-222
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Older Adults, Treadmill Walking, Preferred Walking Speed, Higher-Speed Walking, Heart Rate Variability, Cognitive Training, Gait Performance, Motor-Cognitive Function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PhayaoUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 5 Nov 2026 (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.
This randomized controlled trial evaluates the effects of two individualized treadmill walking speeds followed by cognitive training in older adults with type 2 diabetes. Participants are assigned to one of three groups: treadmill walking at 100% of preferred walking speed (PWS) followed by cognitive training, treadmill walking at 120-130% of PWS followed by the same cognitive training, or a usual-activity control group.
The two exercise groups complete supervised training three times per week for 6 weeks. Cognitive training is performed after treadmill walking rather than simultaneously with walking for safety. The study evaluates heart rate variability, walking and functional performance, and motor-cognitive function. Outcomes are assessed before training, after the 6-week intervention, and again following a 4-week retention period.
Detailed description
This study is a three-arm, parallel-group randomized controlled trial designed to compare the effects of individualized treadmill walking at preferred and higher walking speeds when followed by cognitive training in older adults with type 2 diabetes.
Preferred walking speed (PWS) is determined individually before allocation. Participants assigned to the preferred-speed treadmill group perform supervised treadmill walking at 100% PWS throughout the intervention. Participants assigned to the higher-speed treadmill group perform supervised treadmill walking at 120-130% PWS. Both treadmill groups receive the same cognitive training following completion of the treadmill walking component. The cognitive tasks are performed separately from treadmill walking rather than concurrently to reduce the risk of loss of balance or falls during training.
Training is conducted three times per week for 6 weeks. Participants assigned to the control group continue their usual daily activities, with walking activity monitored using a pedometer, and receive fall-prevention health education without structured treadmill or cognitive training.
Following the 6-week intervention, supervised treadmill and cognitive training are discontinued. Participants are reassessed after a 4-week retention period. The study is designed to determine whether the two treadmill-speed prescriptions produce different responses in cardiac autonomic modulation, gait and functional performance, and motor-cognitive function, and whether observed changes are maintained after cessation of supervised training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm, parallel-group randomized controlled trial in older adults with type 2 diabetes. Participants are randomized to: (1) individualized higher-speed treadmill walking at 120-130% of preferred walking speed (PWS) followed by cognitive training; (2) individualized treadmill walking at 100% PWS followed by the same cognitive training; or (3) a control condition consisting of usual daily activities with step monitoring and fall-prevention health education. The intervention is performed three times per week for 6 weeks. Following completion of the intervention, participants enter a 4-week retention period without supervised treadmill or cognitive training. The final retention assessment is performed 4 weeks after completion of training (Week 10 from baseline).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Experimental: Higher-Speed Treadmill Walking + Cognitive Training | Experimental | Behavioral: Individualized Higher-Speed Treadmill Walking, Behavioral: Cognitive trainingParticipants perform individualized treadmill walking prescribed relative to their baseline preferred walking speed (PWS), using 120-130% PWS as the higher-speed condition. Treadmill walking is performed under supervision three times per week for 6 weeks. After completion of the treadmill walking component, participants perform a separate seated cognitive training session. Cognitive training is not performed concurrently with treadmill walking because of safety considerations related to fall risk in older adults. After the 6-week intervention, participants receive no supervised treadmill or cognitive training for 4 weeks before the retention assessment. |
| Arm 2 - Active Comparator: Preferred-Speed Treadmill Walking + Cognitive Training | Active comparator | Behavioral: Individualized Preferred-Speed Treadmill Walking, Behavioral: Cognitive trainingParticipants perform individualized treadmill walking at 100% of their baseline preferred walking speed (PWS) under supervision three times per week for 6 weeks. After completion of treadmill walking, participants perform the same separate seated cognitive training used in the higher-speed group. Cognitive training is not performed concurrently with treadmill walking. After the 6-week intervention, participants receive no supervised treadmill or cognitive training for 4 weeks before the retention assessment. |
| Arm 3 - Active Comparator: Usual Activity and Fall-Prevention Health Education | Active comparator | Behavioral: Fall-Prevention Health EducationParticipants continue their usual daily activities and do not receive supervised treadmill walking or cognitive training. Participants receive standardized health education on fall prevention. Outcomes are assessed according to the same schedule as the two treadmill-training groups. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adults aged 60 years or older.
- Physician-diagnosed type 2 diabetes mellitus for at least 1 year.
- Low to moderate physical activity level as assessed using the Global Physical Activity Questionnaire (GPAQ), with total physical activity below 3,000 MET-minutes/week or not meeting the WHO criteria for a high physical activity level.
- Able to walk independently without an assistive walking device and able to walk safely on a treadmill.
- Normal or corrected vision and hearing sufficient to follow study instructions and complete the assessments.
Key exclusion criteria (5 listed)
- Unstable cardiovascular disease, including uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled resting hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
- Severe musculoskeletal problems that may limit safe treadmill walking, including severe knee or hip osteoarthritis (grade 3-4), knee or hip replacement surgery within the previous 6 months, or structural foot abnormalities that interfere with walking.
- Neurological conditions that may affect safe walking or balance, including a history of stroke, Parkinson's disease, or vestibular disorders.
- Severe diabetes-related complications, including diabetic foot ulcer or severe peripheral neuropathy with marked loss of foot sensation.
- Current use of medications that substantially affect the central nervous system, balance, or cause clinically relevant drowsiness.
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 |
|---|---|---|
| Individualized Higher-Speed Treadmill WalkingParticipants perform supervised treadmill walking at an individualized speed prescribed relative to their preferred walking speed (PWS). The training speed is progressed from 120% to 130% of PWS during the 6-week intervention. Training is performed three sessions per week. Treadmill walking and cognitive training are performed sequentially rather than simultaneously for safety reasons. After completion of the 6-week intervention, no supervised treadmill training is provided during the 4-week retention period. | Behavioural | Arm 1 - Experimental: Higher-Speed Treadmill Walking + Cognitive Training |
| Individualized Preferred-Speed Treadmill WalkingParticipants perform supervised treadmill walking at 100% of their individualized preferred walking speed (PWS) throughout the 6-week intervention. Training is performed three sessions per week. Treadmill walking and cognitive training are performed sequentially rather than simultaneously. After completion of the 6-week intervention, no supervised treadmill training is provided during the 4-week retention period. | Behavioural | Arm 2 - Active Comparator: Preferred-Speed Treadmill Walking + Cognitive Training |
| Cognitive trainingFollowing completion of each treadmill walking session, participants perform a separate seated cognitive training session. Cognitive exercises include tasks such as backward counting and serial subtraction. Cognitive training is not performed concurrently with treadmill walking because simultaneous motor-cognitive task performance may increase fall risk in older adults. The same cognitive training protocol is provided to both treadmill-training groups during the 6-week intervention. | Behavioural | Arm 1 - Experimental: Higher-Speed Treadmill Walking + Cognitive Training, Arm 2 - Active Comparator: Preferred-Speed Treadmill Walking + Cognitive Training |
| Fall-Prevention Health EducationParticipants receive standardized educational material on fall prevention and continue their usual daily activities throughout the study period. No supervised treadmill walking or cognitive training is provided. | Behavioural | Arm 3 - Active Comparator: Usual Activity and Fall-Prevention Health Education |
Primary outcome
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
Time frame: Baseline and immediately after the 6-week intervention.
Resting heart rate variability is assessed using the SA-3000P heart rate variability analyzer under standardized seated resting conditions. SDNN is the standard deviation of normal-to-normal R-R intervals and is reported in milliseconds (ms). Higher SDNN values indicate greater overall heart rate variability.
Change in Root Mean Square of Successive Differences (RMSSD)
Time frame: Baseline and immediately after the 6-week intervention.
Resting heart rate variability is assessed using the SA-3000P heart rate variability analyzer under standardized seated resting conditions. RMSSD is calculated from successive normal-to-normal R-R interval differences and is reported in milliseconds (ms). RMSSD is used as an index of short-term cardiac vagal modulation.
Change in Timed Up and Go Dual-Task Test Completion Time
Time frame: Baseline and immediately after the 6-week intervention.
Motor-cognitive mobility is assessed using the Timed Up and Go Test performed under a concurrent secondary-task condition. Participants rise from a chair, walk 3 meters, turn, return, and sit down while carrying a cup of water. Completion time is recorded in seconds. A shorter completion time indicates better performance under dual-task conditions.
Change in Figure-of-8 Walk Dual-Task Test Completion Time
Time frame: Baseline and immediately after the 6-week intervention.
Dual-task walking performance is assessed using the Figure-of-8 Walk Test under a concurrent secondary-task condition. Participants walk a figure-of-8 course around two markers while carrying a cup of water. Completion time is recorded in seconds. A shorter completion time indicates better performance.
15 secondary outcomes
Retention of SDNN Following Training Cessation
Time frame: 4 weeks after completion of the 6-week intervention (Week 10 from baseline).
Retention of RMSSD Following Training Cessation
Time frame: 4 weeks after completion of the 6-week intervention (Week 10 from baseline).
Change in 10-Meter Walk Test at Preferred Walking Pace
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in 10-Meter Walk Test at Fast Walking Pace
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Five Times Sit-to-Stand Test
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Timed Up and Go Test
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Figure-of-8 Walk Test
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Stepping Trail-Making Test
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in High-Frequency Normalized Power (HFnu)
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Low-Frequency Normalized Power (LFnu)
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Low-Frequency to High-Frequency Power Ratio (LF/HF)
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in 2-Minute Step Test Performance
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Stroop Test Performance
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Right-Hand Ruler Drop Test Performance
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Change in Left-Hand Ruler Drop Test Performance
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Chonticha Kaewjoho, PT, PhD principal investigator
University of Phayao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Higher-Speed Treadmill Walking, Individualized Preferred-Speed Treadmill Walking and Cognitive training in people with Diabetes Mellitus, Type 2, run by University of Phayao at 1 site in Thailand.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 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 Thailand. 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?
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?
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN) (time frame: Baseline and immediately after the 6-week intervention.). The study lists 4 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 5 Nov 2026.