"A Single-Blind Randomized Controlled Trial to Investigate the Effects of Marching Exercise Combined With Cognitive Training on Physical Performance, Cognitive Function, and Autonomic Cardiovascular Responses in Older Adults With Type 2 Diabetes Mellitus"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Heart rate variability (HRV)
研究概览
简要总结
This study aims to evaluate the effects of a combined marching exercise with cognitive training program on physical performance, cognitive function, and autonomic cardiovascular responses in older adults with type 2 diabetes mellitus. Participants will be randomly assigned to either an intervention group receiving marching exercise with cognitive tasks or a control group receiving usual care. Outcomes will be assessed before and after the intervention period. The findings are expected to provide evidence for a feasible and safe exercise strategy to improve physical and cardiovascular health in older adults with type 2 diabetes.
详细描述
Type 2 diabetes mellitus is highly prevalent among older adults and is associated with declines in physical function, cognitive performance, and autonomic cardiovascular regulation. Reduced physical activity and impaired autonomic nervous system function may increase the risk of functional limitation, falls, and cardiovascular complications in this population. Exercise interventions that simultaneously challenge physical and cognitive domains may provide additional benefits beyond conventional exercise alone.
This single-blind, randomized controlled trial investigates the effects of a marching exercise program combined with cognitive training on physical function, cognitive performance, and autonomic cardiovascular responses in older adults with type 2 diabetes mellitus. Eligible participants aged 60 years and older will be recruited from the community and randomly assigned to either an intervention group or a control group.
The intervention group will participate in a structured marching exercise program integrated with cognitive tasks, conducted three times per week for eight weeks. The control group will receive usual care and standard health advice. Physical performance outcomes will include measures of mobility, balance, and cardiorespiratory fitness. Cognitive function will be assessed using standardized cognitive tasks. Autonomic cardiovascular responses will be evaluated using heart rate variability parameters.
Outcome measures will be assessed at baseline and after completion of the intervention. This study aims to provide clinical evidence supporting a practical and community-based dual-task exercise approach for improving physical, cognitive, and autonomic cardiovascular health in older adults with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to group allocation. Due to the nature of the exercise interventions, care providers and investigators are not blinded.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female.
- •Aged between 60 and 79 years.
- •Medically diagnosed with type 2 diabetes.
- •Peripheral neuropathy with a score of 7 or higher according to the Michigan Neuropathy Screening Instrument (MNSI).
- •Body Mass Index (BMI) within the normal range (between 18.5-24.5 kg/m²).
- •Able to follow instructions and willing to participate in the study.
- •Able to communicate with researchers and provide information independently (researchers will read the questions to the volunteers and allow them to choose their own answers).
- •Able to walk continuously for at least 10 meters without the use of walking aids.
排除标准
- •Neurological disease (e.g., stroke, Parkinson's disease, spinal cord injury) that affects mobility, such as balance and gait.
- •Open wounds on the skin that affect weight-bearing while standing or walking. 1) Deformities or abnormalities of the extremities, or disabilities resulting from the loss of limbs that may affect the study.
- •2) Inflammation of joints and muscles, or musculoskeletal conditions with a pain score greater than 5 out of 10 on the Visual Analogue Scale (VAS), or any pain that affects the study.
- •3) A history of ankle, knee, or hip joint replacement within 6 months prior to participation in the study, or any residual effects from surgery that affect the study.
- •4) Hearing and vision impairments that cannot be corrected with hearing aids and glasses, etc.
- •5) Other complications that may affect the study, such as dizziness, angina pain, uncontrolled high blood pressure, acute illness, or injury, etc.
研究组 & 干预措施
Modified Marching Exercise combined with Cognitive Training
Participants in this group perform a Modified Marching Exercise combined with dual-task cognitive training. The exercise consists of rhythmic marching movements while simultaneously performing cognitive tasks such as backward counting and reciting months in reverse order. Each session lasts approximately 30 minutes and is conducted according to the assigned intervention protocol.
干预措施: Modified Marching Exercise combined with cognitive training group (Other)
Modified Marching Exercise
Participants in this group perform the Modified Marching Exercise alone without concurrent cognitive tasks. The exercise involves rhythmic marching movements adapted to individual functional ability. Each session lasts approximately 30 minutes and follows the same frequency and duration as the experimental intervention.
干预措施: Modified Marching Exercise group (Other)
Control group
Participants in the control group receive health education and educational pamphlets focused on fall prevention. They continue their usual daily activities without participation in a structured exercise program during the study period.
结局指标
主要结局
Heart rate variability (HRV)
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Heart Rate Variability (HRV) Assessment HRV is assessed using the SA-3000P device to evaluate Autonomic Nervous System (ANS) function, stress resistance, and arterial elasticity. The procedure involves a 3-minute measurement using a finger probe while the subject sits quietly. The device automatically analyzes the data to provide time-domain indices (such as SDNN), which are used to assess cardiac function and prognosis.
Handgrip strength test
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Handgrip Strength Testing This test assesses hand and forearm muscle strength using a hand grip dynamometer. The subject stands upright with the dominant arm extended alongside the body (abducted approx. 15 degrees), elbow straight, and palm facing down. Upon the "start" signal, the subject squeezes the device as hard as possible.
Five times sit-to-stand test (FTSST)
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Leg Muscle Strength Test (FTSST) The Five Times Sit to Stand Test measures leg strength using a standard armless chair. The subject performs five consecutive stand-to-sit cycles as quickly and safely as possible from a seated position (hips \~90°). Time is recorded from the start signal until the final return to sitting. The average of three trials is calculated (Kaewjoho et al. 2020).
Timed Up and Go Test (TUGT)
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Assessing Balance Ability (TUGT) The Timed Up and Go Test (TUGT) evaluates dynamic balance and fall risk. The subject starts seated, stands up on signal, walks 3 meters around a cone, and returns to sit as quickly and safely as possible. The average time of three trials is recorded.
Static Balance Single-leg stance test (SLST)
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Static Balance (SLST) The Single-leg stance test assesses static balance. The subject stands on their dominant leg with the other knee bent at 90° and arms crossed over the chest. Timing measures how long the position is maintained without error (e.g., foot touching the ground, moving arms). The average time of three trials is calculated in seconds.
6-minute walk test
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
6-Minute Walk Test (6MWT) This test assesses cardiopulmonary endurance. The subject walks as fast as possible (without running) for 6 minutes on a rectangular course (45m perimeter). Resting is allowed, but the timer continues. The total distance covered is measured to calculate VO2max.
Motor-Cognitive Dual-Task Test:
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Motor-Cognitive Dual-Task Test (S-TMT) The Stepping Trail Making Test assesses dual-task motor-cognitive function. The subject steps on squares numbered 1 to 16 in order as quickly and accurately as possible. The time taken to complete the sequence, including any error corrections, is recorded. The test is performed only once.
Motor-Cognitive Dual-Task Test
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Motor-Cognitive Dual-Task Test (F8WT) The Figure-of-8 Walk Test assesses dynamic balance and turning ability. The subject walks a figure-of-8 pattern around two cones spaced 1.5 meters apart. Time is recorded for one complete lap. In the Dual-Task variation (F8WT-MC), the subject performs the walk while holding a cup of water in their dominant hand.
Montreal Cognitive Assessment (MoCA)
时间窗: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Assessment of Cognitive Impairment (MoCA) The MoCA test is a screening tool for cognitive impairment covering various brain functions (e.g., memory, attention). It involves a 10-15 minute interview with a maximum score of 30. A score below 26 indicates mild cognitive impairment (MCI).
次要结局
未报告次要终点
研究者
Chonticha Kaewjoho
Chonticha Kaewjoho
University of Phayao