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

A

Abant Izzet Baysal University

Status

Completed

Conditions

Older People
Type 2 Diabetes
Reflexology

Treatments

Other: Foot reflexology

Study type

Interventional

Funder types

Other

Identifiers

NCT04416503
AIBU-HSF-SCC-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

48 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

Intervention group
Experimental group
Description:
Foot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up.
Treatment:
Other: Foot reflexology
Control group
No Intervention group
Description:
Usual follow-up was done to the control group.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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