NCT06271382

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 14, 2024

Last Update Submit

February 25, 2025

Conditions

Keywords

AcupressureAnkle Brachial IndexExercise

Outcome Measures

Primary Outcomes (1)

  • 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

    2 week

Study Arms (3)

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.

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).

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)

Other: Foot Ankle Exercise Group

Interventions

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.

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.

Sham Acupressure Group

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

Foot Ankle Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beşkavaklar Aile Sağlığı Merkezi

Bolu, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Saadet CAN ÇİÇEK

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

    STUDY DIRECTOR

Central Study Contacts

Saadet Semra AKTAŞ

CONTACT

Saadet CAN ÇİÇEK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 21, 2024

Study Start

February 24, 2025

Primary Completion

April 24, 2025

Study Completion

April 24, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations