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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmasya University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Severe cardiovascular or musculoskeletal disease

Cognitive impairment preventing participation

Receiving physiotherapy or another structured exercise program during the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Exercise GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline and 8 weeks.

Secondary outcomes

1

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.

Time frame
Baseline and 8 weeks.
2

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.

Time frame
Baseline and 8 weeks.
3

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.

Time frame
Baseline and 8 weeks.

Other outcomes

Sponsors and contacts

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