Diabetic Peripheral NeuropathyNCT07291596
Exercise Effects on Pain, Sleep and Depression in Diabetic Peripheral Neuropathy
A study testing Ankle-Foot Exercise Program in people with Diabetic Peripheral Neuropathy, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Ankle-Foot Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Amasya University Sabuncuoğlu Şerefeddin Education and Research Hospital-Suluova State Hospital
Amasya, Amasya
Merve Çayır Yılmaz, Phd, +90 542 804 22 63, merve.yilmaz@amasya.edu.tr
Simge Eren, Master's student in internal m, +90 506 135 16 87, 1881simge@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Ankle-Foot Exercise Program
- Keywords
- diabetes, neuropathy, Exercise, Pain, Sleep Quality, Depression
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Pain, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-Foot Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | This group will receive foot-ankle exercises 3 days a week, 2 times a day for 8 weeks. Receives: Behavioral: Ankle-Foot Exercise Program |
| Control Group | No intervention | No intervention will be performed in this group. Individuals will receive their routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start22 Dec 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled experimental type.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merve Çayır Yılmaz, PhD, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291596
- Sponsor's protocol ID
- 2025000073
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot-Ankle Exercises on Pain, Sleep Quality and Depression in Individuals With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07291596
- Acronym / sponsor ID
- 2025000073
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- diabetes, neuropathy, Exercise, Pain, Sleep Quality, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled experimental type.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Ankle-Foot Exercise ProgramThis group will receive foot-ankle exercises 3 days a week, 2 times a day for 8 weeks. |
| Control Group | No intervention | –No intervention will be performed in this group. Individuals will receive their routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle-Foot Exercise ProgramA 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. | Behavioural | Exercise Group |
Primary outcome
Visual Analog Scale for Pain
Time frame: Baseline and 8 weeks.
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.
3 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Baseline and 8 weeks.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
Time frame: Baseline and 8 weeks.
Beck Depression Inventory
Time frame: Baseline and 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Diabetic Peripheral Neuropathy
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merve Çayır Yılmaz, PhD principal investigator
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle-Foot Exercise Program in people with Diabetic Peripheral Neuropathy, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Çayır Yılmaz (+905428042263, merve.yilmaz@amasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain (time frame: Baseline and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.