Effects of Marching Exercise With Cognitive Training on Physical, Cognitive Function, and Autonomic Cardiovascular Responses in Older Adults With Type 2 Diabetes Mellitus

NCT ID: NCT07330700

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2025-12-10

Brief Summary

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.

Detailed Description

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.

Conditions

Type2 Diabetes Mellitus; Autonomic Nervous System Imbalance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified Marching Exercise combined with cognitive training group

Intervention Type: OTHER

The exercise program consists of a Modified Marching Exercise that emphasizes lifting the knees to touch a designated rope during each step. A metronome is used to maintain a rhythmic pace of 60-80 beats per minute throughout the training.

In addition, participants perform concurrent cognitive dual-task training designed to stimulate executive function. The cognitive tasks include countdown calculations, backward sequencing of months and weekdays, and a Stroop interference task.

Each session lasts approximately 30-40 minutes and includes a 5-minute warm-up and a 5-minute cool-down. Exercise intensity is individually adjusted according to the participant's fitness level. The program is conducted three times per week for 6 consecutive weeks, for a total of 18 sessions.

This combined cognitive-motor training is designed to integrate physical and cognitive demands in order to improve movement efficiency, balance control, and responses to daily functional stimuli.

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.

Group Type: EXPERIMENTAL

Modified Marching Exercise group

Intervention Type: OTHER

Participants perform a structured Modified Marching Exercise program. The exercise involves rhythmic marching movements with pace controlled by a metronome set at 80 beats per minute. The intervention is conducted three sessions per week for 6 weeks, with each session lasting approximately 30-40 minutes, including warm-up and cool-down periods. All exercise sessions are supervised by a licensed physical therapist.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Modified Marching Exercise combined with cognitive training group

The exercise program consists of a Modified Marching Exercise that emphasizes lifting the knees to touch a designated rope during each step. A metronome is used to maintain a rhythmic pace of 60-80 beats per minute throughout the training.

In addition, participants perform concurrent cognitive dual-task training designed to stimulate executive function. The cognitive tasks include countdown calculations, backward sequencing of months and weekdays, and a Stroop interference task.

Each session lasts approximately 30-40 minutes and includes a 5-minute warm-up and a 5-minute cool-down. Exercise intensity is individually adjusted according to the participant's fitness level. The program is conducted three times per week for 6 consecutive weeks, for a total of 18 sessions.

This combined cognitive-motor training is designed to integrate physical and cognitive demands in order to improve movement efficiency, balance control, and responses to daily functional stimuli.

Intervention Type: OTHER

Modified Marching Exercise group

Participants perform a structured Modified Marching Exercise program. The exercise involves rhythmic marching movements with pace controlled by a metronome set at 80 beats per minute. The intervention is conducted three sessions per week for 6 weeks, with each session lasting approximately 30-40 minutes, including warm-up and cool-down periods. All exercise sessions are supervised by a licensed physical therapist.

Intervention Type: OTHER

Other Intervention Names

MME with Dual-task Marching Exercise; MME

Eligibility Criteria

Inclusion Criteria

1. Male and female.

2. Aged between 60 and 79 years.

3. Medically diagnosed with type 2 diabetes.

4. Peripheral neuropathy with a score of 7 or higher according to the Michigan Neuropathy Screening Instrument (MNSI).

5. Body Mass Index (BMI) within the normal range (between 18.5-24.5 kg/m²).

6. Able to follow instructions and willing to participate in the study.

7. 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).

8. Able to walk continuously for at least 10 meters without the use of walking aids.

Exclusion Criteria

1. Neurological disease (e.g., stroke, Parkinson's disease, spinal cord injury) that affects mobility, such as balance and gait.

2. 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Phayao

OTHER

Sponsor Role: collaborator

Chonticha Kaewjoho

OTHER

Sponsor Role: lead

Responsible Party

Chonticha Kaewjoho

Chonticha Kaewjoho

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Chonticha Kaewjoho

Phayao, , Thailand

Countries

Thailand

Other Identifiers

UPhayaoChonticha-221

Identifier Type: -

Identifier Source: org_study_id