Clinical trial NCT04416503: Effect of Reflexology on Diabetic Foot and Glycemic Control in Elderly Diabetic Individuals
Official title: Effect of Reflexology on Ankle Brachial Index, Diabetic Peripheral Neuropathy, and Glycemic Control in Elderly Diabetic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reflexology
Type 2 Diabetes
Older People
Keywords: Aged
Ankle brachial index
Diabetic neuropathies
Glycated hemoglobin A
Musculoskeletal manipulations
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2020-06-04
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Means of Ankle Brachial Index score
timeFrame: 3-month change
measure: Means of Diabetic peripheral neuropathy score
timeFrame: 3-month change
measure: HbA1c levels (%)
timeFrame: 3-month change
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Elderly Health Center
Study officials:
affiliation: Bolu Provincial Health Directorate
name: Süleyman ÖZSARI, PhD, DR
role: STUDY_DIRECTOR
References:
citation: 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.