Diabetic neuropathy. Diabetes mellitus due to underlying condition with diabetic nephropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants must be aged between 40 and 79 years. Participants must have type 2 diabetes. Diabetes diagnosis must be confirmed and registered at the health center. HbA1c level in adults must be below 7%. In elderly patients or those with a high risk of hypoglycemia, HbA1c should be below 8% to maintain safety. Peripheral neuropathy must be confirmed by diagnostic tests. Pittsburgh Sleep Quality Index score indicating poor sleep must be greater than 6. Total fatigue questionnaire score must be equal to or greater than 60. Physical fatigue score must be equal to or greater than 9. Mental fatigue score must be equal to or greater than 9. Reduced motivation score must be equal to or greater than 9. Reduced activity score must be equal to or greater than 10. General fatigue score must be equal to or greater than 11. Participant must be able to complete the questionnaire. Participant must provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Neurological disorders unrelated to the study (e.g., Multiple Sclerosis, spinal cord injury). Presence of any active foot wound or skin lesion that interferes with the intervention. Current use of medications that affect sleep or fatigue. History of injury or surgery in the lower limbs. History of stimulant drug use. Pregnancy or lactation. History of alcohol consumption. Participation in similar interventions (e.g., massage therapy, physiotherapy) during the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Quality. Timepoint: The primary outcome measurement time points in this study include assessing sleep quality at baseline (before intervention) and at the end of weeks 1, 2, 3, and 4 of the intervention. Method of measurement: In this study, sleep quality is measured using the Pittsburgh Sleep Quality Index questionnaire. This questionnaire consists of 19 items assessing sleep quality across seven dimensions, including subjective sleep quality, sleep duration, and sleep disturbances. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue. Timepoint: It is at the beginning (before the intervention starts) and at the end of the first, second, third, and fourth weeks of the intervention. Method of measurement: Fatigue is assessed using the Multidimensional Fatigue Inventory questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Khomein University of Medical Sciences