The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes

NCT ID: NCT06271382

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2025-04-24

Brief Summary

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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

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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

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupressure Group

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.

Group Type EXPERIMENTAL

Acupressure Group

Intervention Type OTHER

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 Group

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).

Group Type SHAM_COMPARATOR

Sham Acupressure Group

Intervention Type OTHER

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 Group

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)

Group Type EXPERIMENTAL

Foot Ankle Exercise Group

Intervention Type OTHER

Exercise will be performed regularly for 2 weeks, 3 days a week for a maximum of 30 minutes.

Interventions

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Acupressure Group

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.

Intervention Type OTHER

Sham Acupressure Group

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.

Intervention Type OTHER

Foot Ankle Exercise Group

Exercise will be performed regularly for 2 weeks, 3 days a week for a maximum of 30 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Saadet Can Çiçek

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saadet CAN ÇİÇEK

Role: STUDY_DIRECTOR

http://www.ibu.edu.tr/tr

Locations

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Beşkavaklar Aile Sağlığı Merkezi

Bolu, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Saadet Semra AKTAŞ

Role: CONTACT

+905314914448

Saadet CAN ÇİÇEK

Role: CONTACT

+905062846936

Facility Contacts

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Beşkavakalar Aile Sağlığı Merkezi Aile Sağlığı Merkezi

Role: primary

+903742705005

Other Identifiers

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AIBU-SBF-SA-05

Identifier Type: -

Identifier Source: org_study_id

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