Exercise Effects on Pain, Sleep and Depression in Diabetic Peripheral Neuropathy

The Effect of Foot-Ankle Exercises on Pain, Sleep Quality and Depression in Individuals With Diabetic Peripheral Neuropathy

It is known that the pain experienced by individuals with diabetic neuropathy negatively impacts sleep and quality of life, leading to numerous psychosocial problems such as anxiety and depression. Studies in the literature indicate that exercise, a non-pharmacological method, improves pain and sleep quality in individuals with diabetic neuropathy. However, no studies have been found evaluating the effects of foot-ankle exercises on pain, sleep quality, and depression in individuals with diabetic neuropathy.

This research aims to examine the effects of foot-ankle exercises on pain, sleep quality, and depression in individuals with diabetic peripheral neuropathy.

This randomized controlled experimental study will be conducted with 70 individuals with diabetes diagnosed with diabetic neuropathy, registered in the patient information systems of two public hospitals. The foot-ankle exercises will be performed by the patients in their homes, twice a day, three days a week, for eight weeks. The research data are as follows: The Introductory Information Form will be collected using the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) Pain Scale, VAS-Visual Analog Scale, Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory (BDI).

This study is important because it will determine the effects of foot and ankle exercises on pain, sleep disturbances, and depression, which are common problems experienced by individuals with diabetic neuropathy.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Behavioral: Ankle-Foot Exercise Program

Detailed Description

Diabetic neuropathy affects approximately 50% of individuals with diabetes throughout their lives. Diabetic neuropathy accounts for approximately 30-50% of all neuropathy diagnoses. Diabetic neuropathy is classified according to the affected area. Peripheral involvement describes involvement of the lower or upper extremities. Peripheral involvement is more common than involvement of other areas, with a prevalence of 16-87% in individuals with diabetes. Individuals with diabetic peripheral neuropathy typically present to the hospital with numbness, tingling, pain, and loss of sensation in the extremities.

The symptoms experienced in diabetic neuropathy negatively impact individuals' quality of life, and pain is one of the most common symptoms. Diabetic neuropathic pain can be spontaneous, constant, or intermittent, and can be described as burning, stinging, tingling, numbness, or coldness, and can be localized to one or more areas. Neuropathic pain generally worsens at night and is more common in the feet.

Management of diabetic neuropathy includes the use of pharmacological agents, glycemic control, lifestyle changes, risk factor management, assessment of foot ulcer risk, foot care, and non-pharmacological interventions.

Non-pharmacological treatment methods have been shown to be effective in reducing pain and improving quality of life. These include transcutaneous electrical nerve stimulation, spinal cord stimulation, transcranial magnetic stimulation, reflexology, aromatherapy massage, spa treatments, and exercise.

Exercises are also included among the treatment methods.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve Çayır Yılmaz; Phone Number: +905428042263; Email: merve.yilmaz@amasya.edu.tr

Study Locations

• Turkey (Türkiye)
  • Amasya
    • Amasya, Amasya, Turkey (Türkiye)
      • Amasya University Sabuncuoğlu Şerefeddin Education and Research Hospital-Suluova State Hospital
      • Contact: Merve Çayır Yılmaz, Phd; Phone Number: +90 542 804 22 63; Email: merve.yilmaz@amasya.edu.tr
      • Contact: Simge Eren, Master's student in internal m; Phone Number: +90 506 135 16 87; Email: 1881simge@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age and older
• Diagnosed with diabetic peripheral neuropathy for at least 6 months S-LANSS pain score ≥ 12
• Able to perform the exercise program
• Voluntary participation and informed consent

Exclusion Criteria:

• Pregnancy
• Severe cardiovascular or musculoskeletal disease
• Cognitive impairment preventing participation
• Receiving physiotherapy or another structured exercise program during the study
• Any other condition deemed inappropriate by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; This group will receive foot-ankle exercises 3 days a week, 2 times a day for 8 weeks.	Behavioral: Ankle-Foot Exercise Program; A structured ankle-foot exercise program consisting of walking warm-up, ankle dorsiflexion and plantarflexion, hamstring stretching, toe and heel raises, towel-grasp toe exercise, and rolling massage with a spiky roller. Exercises will be performed 3 times per week, twice per day, for 8 weeks.
No Intervention: Control Group; No intervention will be performed in this group. Individuals will receive their routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Pain	Pain severity will be assessed using the Visual Analog Scale for Pain, a 10-cm line on which participants rate their pain intensity from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent more severe pain.	Baseline and 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which includes 19 items, of which 18 contribute to scoring across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is rated from 0 to 3, and component scores are summed to yield a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.	Baseline and 8 weeks.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale	Neuropathic pain will be evaluated using the Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Pain Scale, which includes 7 items. The first five items assess neuropathic pain symptoms, and the last two items assess the presence of allodynia and reduced pain sensation. Items are scored as "yes/no," producing a total score between 0 and 24. Scores ≥12 support neuropathic pain, while scores <12 suggest nociceptive pain. Higher scores indicate greater neuropathic pain severity.	Baseline and 8 weeks.
Beck Depression Inventory	Depression severity will be measured using the Beck Depression Inventory (BDI), a 21-item self-report instrument that assesses cognitive, affective, and somatic symptoms. Each item is scored from 0 to 3, producing a total score that ranges from 0 to 63. Higher scores indicate more severe depressive symptoms.	Baseline and 8 weeks.

Collaborators and Investigators

• Sponsor: Amasya University
• Investigators: Principal Investigator: Merve Çayır Yılmaz, PhD, Amasya University

Study record dates

Study Major Dates

• Study Start (Estimated): December 22, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Depression; diabetes; Exercise; Pain; Sleep Quality; neuropathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Pain; Depression; Diabetes Mellitus; Sleep Initiation and Maintenance Disorders; Motor Activity
• Other Study ID Numbers: 2025000073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) will be shared. Only the full thesis text (PDF) will be available through the YÖK National Thesis Center after completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No