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

NCT ID: NCT07291596

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-22
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise Group

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

Group Type: EXPERIMENTAL

Ankle-Foot Exercise Program

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amasya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merve Çayır Yılmaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Amasya University

Locations

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

Amasya, Amasya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Merve Çayır Yılmaz

Role: CONTACT

Phone: +905428042263

Email: merve.yilmaz@amasya.edu.tr

Facility Contacts

Merve Çayır Yılmaz, Phd

Role: primary

Simge Eren, Master's student in internal m

Role: backup

Other Identifiers

2025000073

Identifier Type: -

Identifier Source: org_study_id