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

NCT04416503 | Completed

• 1 other identifier: AIBU-HSF-SCC-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Reflexology; Type 2 Diabetes; Older People

Keywords

Aged; Ankle brachial index; Diabetic neuropathies; Glycated hemoglobin A; Musculoskeletal manipulations

Outcome Measures

Primary Outcomes (3)

• Means of Ankle Brachial Index score

  Vascular assessment test to assess peripheral circulation in the lower limbs. The measurement, obtained by dividing the highest ankle arterial pressure (posterior tibial or dorsalis pedis) on the same side by brachial pressure, was evaluated using a 5-10-MHz handheld Doppler device and a blood pressure cuff.

  3-month change

• Means of Diabetic peripheral neuropathy score

  Measurement parameter testing whether there is nerve damage due to diabetes by physical examination of the foot. The examination was determined using symptom and disability scores. Symptom scores included questions related to complaints experienced by patients, the location of the complaints, the presence of night or day symptoms, and how the symptoms relieved/subsided. Disability scores were determined with four parameters: vibration sensation (128 Hz tuning fork), pinprick sensation, achilles reflex and sensitivity to touch (Semmes-Weinstein nylon monofilaments 10 g).Participant responses and examination findings were scored according to a guideline and a neuropathy score was obtained for each participant.

  3-month change

• HbA1c levels (%)

  Blood test to evaluate glycemic control. Blood sample was collected in EDTA-coated tubes (2 mL of whole) from the participants.

  3-month change

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Foot reflexology

Control group

NO INTERVENTION

Usual follow-up was done to the control group.

Interventions

Foot reflexology OTHER

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

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Bolu Elderly Health Center

Bolu, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34237668 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• Süleyman ÖZSARI, PhD, DR

  Bolu Provincial Health Directorate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2018
• Primary Completion: April 22, 2019
• Study Completion: July 1, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)