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Effectiveness of Additional Strengthening Exercises Combined with Gabapentin in Managing Restless Legs Syndrome among Hemodialysis Patients: An Open-Label Randomized Controlled Trial

Effectiveness of Additional Strengthening Exercises Combined with Gabapentin in Managing Restless Legs Syndrome among Hemodialysis Patients: An Open-Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250314004
Enrollment
55
Registered
2025-03-14
Start date
2024-10-04
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Restless legs syndrome in hemodialysis patients Restless legs syndrome, hemodialysis, end stage kidney disease, intradialytic exercise, gabapentin

Interventions

Intradialytic quadriceps strengthening exercises in each hemodialysis sessions for 12 weeks combined with gabapentin 100 mg per day ,gabapentin 100 mg per day
Intradialytic strengthening exercises combined with gabapentin ,Gabapentin alone

Sponsors

Phramongkutklao hospital, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 20 years old or older, 2. End stage renal disease patients undergoing hemodialysis at least 3 months with adequate dialysis delivery, 3. Diagnosis of Restless legs syndrome based on international RLS study Group, 4. Persistent Restless legs syndrome symptoms occurring at least twice per week , 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Use of gabapentin or dopamine agonists for restless legs syndrome treatment within the past 12 weeks 2.Ferritin level < 200 ng/ml, 3.Pregnancy , 4.Diagnostic of depression or psychiatric disorder, 5.Obstructive sleep apnea , 6.Physical limitations such as leg amputation, 7.Unstable patients or critical illness

Design outcomes

Primary

MeasureTime frame
Change in international Restless legs syndrome study group severity scale and grading between groups 12 weeks international Restless legs syndrome study group rating scale

Secondary

MeasureTime frame
Quality of life and sleep quality 12 weeks Kidney disease specific quality of life 36 questionnaires (KDQOL-36), Epworth sleepiness score questionnaires

Countries

Thailand

Contacts

Public ContactSiriwan Sornseney

Phramongkutklao Hospital

siriwansornseney@gmail.com66935539494

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026