Diabetes Mellitus, Type 2NCT06271382
The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes
A study testing Acupressure Group and Foot Ankle Exercise Group in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Acupressure Group and Foot Ankle Exercise Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2025to 24 Apr 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with type 2 diabetes
- Be 18 years or older
- Ability to speak Turkish
- Ability to establish verbal communication
- Volunteering to participate in the research
Who cannot join
- Presence of any psychiatric disease diagnosed by a physician
- Presence of diabetic ulcers on both feet and legs
- Presence of any amputation in the foot or leg
- Having myalgia in the foot,
- Foot fracture
- Edema in the feet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beşkavaklar Aile Sağlığı Merkezi
Bolu
Beşkavakalar Aile Sağlığı Merkezi Aile Sağlığı Merkezi, +903742705005, semraaktas140@gmail.com
About this study
Official title: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.
Read the detailed description
Diabetes Mellitus (DM) is a health problem that affects many lifelong systems and organs throughout the world, increases the risk of premature death, affects the individual, family, society and the world, has a serious spiritual and financial care burden, and has important and vital consequences.
Diabetes can cause damage to nerves as well as small and large vessels. Patients who have had DM for a long time will experience circulatory disorders in the upper and lower extremities.
Ankle-Brachial Index (ABI) is a non-invasive examination of blood vessels that functions to detect clinical signs and symptoms of ischemia, reduced peripheral perfusion that can lead to angiopathy and diabetic neuropathy.
Studies indicate that foot exercise and acupressure application can be used as an alternative intervention to increase the value of the ankle-brachial index in patients with type 2 diabetes.
When the literature was examined, no comprehensive study could be found comparing the effect of foot exercise and acupressure application on the Ankle Brachial Index in diabetic patients in our country. It is thought that acupressure application and ankle exercises will accelerate peripheral circulation and may be effective on the ankle brachial index.
This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Acupressure Group, Sham Acupressure Group, Foot Ankle Exercise Group
- Keywords
- Acupressure, Ankle Brachial Index, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure GroupOther
In the research, the participant in the acupressure group will receive acupressure application 3 times a week for 2 weeks, a total of 6 times.
Depending on the preparation and pressure time on the 5 selected points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes.
Sham Acupressure GroupOther
Depending on the preparation and pressure time on the 5 selected sham points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes.
Patients in the sham acupressure group will receive acupressure 6 times in total, 3 times a week for 2 weeks. The practitioner will do the first acupressure at the Family Health Center, and the person with type 2 diabetes will do the others at home. Ankle Brachial Index evaluation will be performed by the researcher at the Family Health Center a total of 3 times before the intervention, 1 week after the intervention and 2 weeks after the intervention.
Foot Ankle Exercise GroupOther
Exercise will be performed regularly for 2 weeks, 3 days a week for a maximum of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Experimental | In the research, acupressure will be applied to the patients in the acupressure group on LR 3 Taichung(LR 3), Tai Xi (KI 3), San Yin Jiao(SP 6), Xue Hai (SP 10), Zusanli(ST 36 ) points. Receives: Other: Acupressure Group |
| Sham Acupressure Group | Sham comparator | The same process will continue with the acupressure group by applying pressure to different points in the group where acupressure is applied to the sham points.
Pressure will be applied on the bone area where the meridians do not pass, parallel to the points where acupressure is applied to the sham points (approximately 1-1.5 cm away). Receives: Other: Sham Acupressure Group |
| Foot Ankle Exercise Group | Experimental | The foot and ankle exercise complex includes the following exercises.
1. Pulling the foot towards itself from the ankle up
2. Bending the foot downwards from the ankle
3. Opening the feet like a fan, moving the toes inward and outward, left and right
4. Circling exercise with ankle
5. Towel folding exercise
6. Bottle rolling exercise under your feet (The water in the bottle will be warm tap water) Receives: Other: Foot Ankle Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Brachial Index
The ABI evaluation form includes right and left ankle blood pressure values, right and left arm blood pressure values and the ratios of these values.
ABI interpretation:
0.9-1.3 is normal, 0.8-0.9 Risky or Mild Stenosis, 0.8-0.4 Moderate Stenosis, <0.4 Severe Stenosis
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start24 Feb 2025
- Primary completion24 Apr 2025 (estimated)
- Study completion24 Apr 2025 (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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
- Investigators
- Saadet CAN ÇİÇEK, Study director, http://www.ibu.edu.tr/tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271382
- Sponsor's protocol ID
- AIBU-SBF-SA-05
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06271382
- Acronym / sponsor ID
- AIBU-SBF-SA-05
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Acupressure, Ankle Brachial Index, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 24 Apr 2025 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 21 Feb 2024 (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 was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.
Detailed description
Diabetes Mellitus (DM) is a health problem that affects many lifelong systems and organs throughout the world, increases the risk of premature death, affects the individual, family, society and the world, has a serious spiritual and financial care burden, and has important and vital consequences.
Diabetes can cause damage to nerves as well as small and large vessels. Patients who have had DM for a long time will experience circulatory disorders in the upper and lower extremities.
Ankle-Brachial Index (ABI) is a non-invasive examination of blood vessels that functions to detect clinical signs and symptoms of ischemia, reduced peripheral perfusion that can lead to angiopathy and diabetic neuropathy.
Studies indicate that foot exercise and acupressure application can be used as an alternative intervention to increase the value of the ankle-brachial index in patients with type 2 diabetes.
When the literature was examined, no comprehensive study could be found comparing the effect of foot exercise and acupressure application on the Ankle Brachial Index in diabetic patients in our country. It is thought that acupressure application and ankle exercises will accelerate peripheral circulation and may be effective on the ankle brachial index.
This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Other: Acupressure GroupIn the research, acupressure will be applied to the patients in the acupressure group on LR 3 Taichung(LR 3), Tai Xi (KI 3), San Yin Jiao(SP 6), Xue Hai (SP 10), Zusanli(ST 36 ) points. |
| Sham Acupressure Group | Sham comparator | Other: Sham Acupressure GroupThe same process will continue with the acupressure group by applying pressure to different points in the group where acupressure is applied to the sham points. Pressure will be applied on the bone area where the meridians do not pass, parallel to the points where acupressure is applied to the sham points (approximately 1-1.5 cm away). |
| Foot Ankle Exercise Group | Experimental | Other: Foot Ankle Exercise GroupThe foot and ankle exercise complex includes the following exercises. 1. Pulling the foot towards itself from the ankle up 2. Bending the foot downwards from the ankle 3. Opening the feet like a fan, moving the toes inward and outward, left and right 4. Circling exercise with ankle 5. Towel folding exercise 6. Bottle rolling exercise under your feet (The water in the bottle will be warm tap water) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with type 2 diabetes
- Be 18 years or older
- Ability to speak Turkish
- Ability to establish verbal communication
- Volunteering to participate in the research
Key exclusion criteria (6 listed)
- Presence of any psychiatric disease diagnosed by a physician
- Presence of diabetic ulcers on both feet and legs
- Presence of any amputation in the foot or leg
- Having myalgia in the foot,
- Foot fracture
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 |
|---|---|---|
| Acupressure GroupIn the research, the participant in the acupressure group will receive acupressure application 3 times a week for 2 weeks, a total of 6 times. Depending on the preparation and pressure time on the 5 selected points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes. | Other | Acupressure Group |
| Sham Acupressure GroupDepending on the preparation and pressure time on the 5 selected sham points (a total of 10 points will be applied since the partner of each point on the other extremity will be applied), the session duration for an individual will be approximately 18-20 minutes. Patients in the sham acupressure group will receive acupressure 6 times in total, 3 times a week for 2 weeks. The practitioner will do the first acupressure at the Family Health Center, and the person with type 2 diabetes will do the others at home. Ankle Brachial Index evaluation will be performed by the researcher at the Family Health Center a total of 3 times before the intervention, 1 week after the intervention and 2 weeks after the intervention. | Other | Sham Acupressure Group |
| Foot Ankle Exercise GroupExercise will be performed regularly for 2 weeks, 3 days a week for a maximum of 30 minutes. | Other | Foot Ankle Exercise Group |
Primary outcome
Ankle Brachial Index
Time frame: 2 week
The ABI evaluation form includes right and left ankle blood pressure values, right and left arm blood pressure values and the ratios of these values. ABI interpretation: 0.9-1.3 is normal, 0.8-0.9 Risky or Mild Stenosis, 0.8-0.4 Moderate Stenosis, <0.4 Severe Stenosis
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Saadet CAN ÇİÇEK study director
http://www.ibu.edu.tr/tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure Group and Foot Ankle Exercise Group in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Contact Saadet Semra AKTAŞ (+905314914448, semraaktas140@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Brachial Index (time frame: 2 week). 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 27 Feb 2025.