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

NCT07291596 | Not Yet Recruiting

• 1 other identifier: 2025000073
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

diabetes; neuropathy; Exercise; Pain; Sleep Quality; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pittsburgh Sleep Quality Index

  Baseline and 8 weeks.

• Self-report Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale

  Baseline and 8 weeks.

• Beck Depression Inventory

  Baseline and 8 weeks.

Study Arms (2)

Exercise Group

EXPERIMENTAL

This group will receive foot-ankle exercises 3 days a week, 2 times a day for 8 weeks.

Behavioral: Ankle-Foot Exercise Program

Control Group

NO INTERVENTION

No intervention will be performed in this group. Individuals will receive their routine care.

Interventions

Ankle-Foot Exercise Program BEHAVIORAL

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University Sabuncuoğlu Şerefeddin Education and Research Hospital-Suluova State Hospital

Amasya, Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity; Pain; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms

Study Officials

• Merve Çayır Yılmaz, PhD

  Amasya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Çayır Yılmaz

CONTACT

+905428042263; merve.yilmaz@amasya.edu.tr

Study Design

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

Model Details: This study is a randomized controlled experimental type.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start: December 22, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)