An interventional study of Individualized Higher-Speed Treadmill Walking and Individualized Preferred-Speed Treadmill Walking in Diabetes Mellitus, Type 2, sponsored by University of Phayao. Active, not recruiting at 1 site in Thailand. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Phayao · Not applicable, Interventional, and Treatment
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Phayao is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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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.
Behavioral: Individualized Higher-Speed Treadmill Walking · Behavioral: Cognitive training
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.
Behavioral: Individualized Preferred-Speed Treadmill Walking · Behavioral: Cognitive training
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.
Behavioral: Fall-Prevention Health Education
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and immediately after the 6-week intervention.
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).
Time frame: 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).
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)
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.
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)
Low-frequency normalized power is obtained from resting heart rate variability analysis using the SA-3000P and is reported in normalized units.
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)
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.
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
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.
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
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.
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
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.
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
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.
Time frame: Baseline, immediately after the 6-week intervention, and 4 weeks after completion of the intervention (Week 10 from baseline).
Ran from Apr 2026 to primary completion in Aug 2026, 4 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 4 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Phayao