Effect of Reflexology on Diabetic Foot and Glycemic Control in Elderly Diabetic Individuals

NCT ID: NCT04416503

Last Updated: 2020-06-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-01

Brief Summary

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Background: Glycemic control can be difficult in the elderly with diabetes.Diabetic foot problems characterized by vascular and neuropathy are serious complications. The effectiveness of reflexology has been demonstrated to achieve glycemic control and manage diabetic foot problems.

Objectives: To determine the effect of foot reflexology on ankle brachial index (ABI), diabetic peripheral neuropathy (DPN) and glycemic control in elderly diabetic individuals.

Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey. Participants: 48 individuals aged 65 and over enrolled in the elderly health center were included.

Methods: The elderly were randomized into two groups (study, n=24; control,n=24). Foot reflexology was performed for 12 week in the study group, whereas the control group continued their routine treatment and follow-up. Both groups underwent a comprehensive foot examination for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, glycemic control (glycated hemoglobin-HbA1c) was evaluated. An independent two-sample t-test was performed for pre- and post-test between-group comparisons; an effect size analysis was performed to determine the effect of intervention.

Detailed Description

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Background: Elderly individuals often refer to the health facility with the complications of diabetes as the first reason. Glycemic control can be quite difficult in elderly diabetic individuals compared to other age groups. Diabetic foot problems, leading to progressive problems from circulatory disorders and nervous loss to organ loss, constitute the most serious complications. Foot reflexology has been shown as a useful practice in the management of glycemic control and foot problems in diabetic individuals. Reflexology has been shown to have a positive effect on glycemic control and the management of diabetic foot problems. There are clinical trials of reflexology in Turkey for use in a variety of diseases or conditions, but there are no studies about diabetes or diabetes complications. Therefore, current research is a first in this regard. In this context, this study has been performed to determine the effect of foot reflexology on ABI, DPN, and glycemic control in elderly diabetic individuals.

Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey. Participants: 48 individuals aged 65 and over enrolled in the elderly health center were included.

Measures: At baseline, subjective area was collected by participant information form. Glycemic control was evaluated with HbA1c. DPN and ABI assessment were performed by physical examination of the foot at baseline and three months later.

Methods: The elderly were randomized into two groups (study, n=24; control, n=24). Foot reflexology was performed for 12 week in the study group, whereas the control group continued their routine treatment and follow-up. Both groups underwent a comprehensive foot examination for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, HbA1c was evaluated. An independent two-sample t-test was performed for pre- and post-test between-group comparisons; an effect size analysis was performed to determine the effect of intervention.

Conditions

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Reflexology Type 2 Diabetes Older People

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Foot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up.

Group Type EXPERIMENTAL

Foot reflexology

Intervention Type OTHER

Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.

Control group

Usual follow-up was done to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Foot reflexology

Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Older than 65 years with type 2 diabetes
* No fractures or open wounds on both lower limbs
* No single or double sided amputation on the lower limbs.

Exclusion Criteria

* Uncontrolled high blood pressure
* Acute infection with fever
* Acute surgical conditions
* Receiving dialysis treatment
* Being a verbal communication problem related to Alzheimer's or dementia
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Süleyman ÖZSARI, PhD, DR

Role: STUDY_DIRECTOR

Bolu Provincial Health Directorate

Locations

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Bolu Elderly Health Center

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cicek SC, Demir S, Yilmaz D, Yildiz S. Effect of reflexology on ankle brachial index, diabetic peripheral neuropathy, and glycemic control in older adults with diabetes: A randomized controlled trial. Complement Ther Clin Pract. 2021 Aug;44:101437. doi: 10.1016/j.ctcp.2021.101437. Epub 2021 Jul 4.

Reference Type DERIVED
PMID: 34237668 (View on PubMed)

Other Identifiers

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AIBU-HSF-SCC-01

Identifier Type: -

Identifier Source: org_study_id

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