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Ischemic preconditioning for restless leg syndrome in maintenance hemodialysis patients: a randomized controlled trial

Ischemic preconditioning for restless leg syndrome in maintenance hemodialysis patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066008
Enrollment
Unknown
Registered
2022-11-21
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless leg syndrome

Interventions

The IPC treatment group:Ischemic preconditioning
Sham IPC control group:Subtherapeutic ischemic preconditioning

Sponsors

Changzhou Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 18 years old; 2. Reliable diagnosis of RLS according to the International Classification of Sleep Disorders and the Revised Diagnostic and Coding Manual of the American Academy of Sleep Medicine; 3. Regular dialysis for at least 3 months, 3 times/week, 4 hours each time; 4. The patient's vital signs are basically stable and in good condition, and the expected survival time is more than 2 years; 5. In line with the principles of medical ethics, patients and their families voluntarily sign informed consent; 6. No contraindications related to imaging examination; 7. Subjects taking iron, antidepressants, prescription medications, or hemoperfusion for RLS may be enrolled only if they have been taking a steady dose of medication for more than two months or if they report persistent symptoms after hemoperfusion.

Exclusion criteria

Exclusion criteria: 1. Autar deep vein thrombosis risk assessment Scale score >= 7 points; 2. Patients with severe hypertension (recent blood pressure control systolic blood pressure>160mmHg); 3. Patients with severe swelling of lower limb muscles or joints, limb movement disorder and inability to tolerate limb ischemic preconditioning intervention; 4. Patients with severe infection or acute cardiovascular and cerebrovascular disease within the last 6 months; 5. Uncontrolled infection and unexplained fever and vasculitis, Raynaud's disease, diabetic foot, large capillary brittleness, multiple peripheral neuropathy; 6. coagulopathy or active visceral hemorrhage and malignancy; 7. there are mental or physical limitations (e.g. disorders of consciousness, persons with mental illness) that prevent the collection of data through questionnaires; 8. Have used the IPC device before.

Design outcomes

Primary

MeasureTime frame
International RLS research group restless leg severity rating scale;

Secondary

MeasureTime frame
Clinical Global Impressions-Severity of Illness scale;Medical Outcomes Study Sleep Scale;serum creatinine;blood urea nitrogen;albumin;Parathyroid hormone;Serum calcium;Serum phosphorus;resting-state functional MRI;

Countries

China

Contacts

Public ContactTongqiang Liu

Changzhou Second People's Hospital

liuyf1106@126.com+86 13775606952

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026