Type2 Diabetes MellitusNCT07330700
Effects of Marching Exercise With Cognitive Training on Physical, Cognitive Function, and Autonomic Cardiovascular Responses in Older Adults With Type 2 Diabetes Mellitus
A study testing Modified Marching Exercise combined with cognitive training group and Modified Marching Exercise group in people with Type2 Diabetes Mellitus and Autonomic Nervous System Imbalance, run by Chonticha Kaewjoho at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Autonomic Nervous System Imbalance
- What is being tested?
- Modified Marching Exercise combined with cognitive training group and Modified Marching Exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jul 2025to 10 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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"
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.
Read the 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.
- Being tested
- Modified Marching Exercise combined with cognitive training group, Modified Marching Exercise group
- Keywords
- Type2 Diabetes Mellitus, Dual-task Exercise, Marching Exercise, Autonomic Nervous System, Heart Rate Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Marching Exercise combined with cognitive training groupOther
Also called MME with Dual-task Marching Exercise
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 groupOther
Also called MME
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified Marching Exercise combined with Cognitive Training | Experimental | 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. Receives: Other: Modified Marching Exercise combined with cognitive training group |
| Modified Marching Exercise | Experimental | 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. Receives: Other: Modified Marching Exercise group |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Handgrip strength test
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Five times sit-to-stand test (FTSST)
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).
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Timed Up and Go Test (TUGT)
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Static Balance Single-leg stance test (SLST)
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
6-minute walk test
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Motor-Cognitive Dual-Task Test:
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Motor-Cognitive Dual-Task Test
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.
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Montreal Cognitive Assessment (MoCA)
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).
Measured: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Jul 2025
- Primary completion5 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- Participants are randomly assigned to one of three parallel groups: 1. Modified Marching Exercise combined with cognitive training 2. Modified Marching Exercise alone, or 3. Control group receiving usual care. Outcomes are assessed before and after the 6-week intervention period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonticha Kaewjoho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Phayao
- Responsible party
- Sponsor-investigator, Chonticha Kaewjoho, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330700
- Sponsor's protocol ID
- UPhayaoChonticha-221
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 14 Jan 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT07330700
- Acronym / sponsor ID
- UPhayaoChonticha-221
- Keywords
- Type2 Diabetes Mellitus, Dual-task Exercise, Marching Exercise, Autonomic Nervous System, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chonticha KaewjohoUniversity, hospital or other
- Collaborators
- University of Phayao
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 9 Jan 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups: 1. Modified Marching Exercise combined with cognitive training 2. Modified Marching Exercise alone, or 3. Control group receiving usual care. Outcomes are assessed before and after the 6-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Modified Marching Exercise combined with Cognitive Training | Experimental | Other: Modified Marching Exercise combined with cognitive training groupParticipants 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. |
| Modified Marching Exercise | Experimental | Other: Modified Marching Exercise groupParticipants 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Modified Marching Exercise combined with cognitive training groupAlso: MME with Dual-task Marching ExerciseThe 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. | Other | Modified Marching Exercise combined with Cognitive Training |
| Modified Marching Exercise groupAlso: MMEParticipants 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. | Other | Modified Marching Exercise |
Primary outcome
Heart rate variability (HRV)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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:
Time frame: 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
Time frame: 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)
Time frame: 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).
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 14 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Marching Exercise combined with cognitive training group and Modified Marching Exercise group in people with Type2 Diabetes Mellitus and Autonomic Nervous System Imbalance, run by Chonticha Kaewjoho 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 8 inclusion and 6 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 14 Jan 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?
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?
Heart rate variability (HRV) (time frame: Baseline, immediately after 6 weeks of intervention, and 1-month follow-up). The study lists 9 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 14 Jan 2026.