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. 2016 Nov 7;2016(11):CD010690. doi: 10.1002/14651858.CD010690.pub2

Giannaki 2013.

Methods
  • Study design: parallel placebo‐controlled RCT

  • Study duration: September 2007 to October 2009

  • Study follow‐up period: 6 months

Participants
  • Country: Greece

  • Setting: single centre

  • Health status: stable adult HD patients; specialist neurologist diagnosed patients with RLS using IRLSSG criteria

  • Number: 32; treatment group 1 (16); treatment group 2 (8), control group (8)

  • Mean age ± SD (years): treatment group 1 (56.4 ± 12.5); treatment group 2 (55.7 ± 10.4); control group (56.8 ±16.5)

  • Sex (M/F): treatment group 1 (11/4); treatment group 2 (4/3); control group (5/2)

  • Exclusion criteria: diagnosed neuropathies (3, clinically examined by a neurologist); catabolic state (2, opportunistic infections and active inflammation); within 3 months prior to the start of the study CRP > 3.0 mg/L (1); unable to exercise (3); refusal to participate for personal reasons (4)

Interventions Treatment group 1
  • Progressive aerobic exercise training (recumbent cycling) at an intensity of 60% to 65% of patient's maximal exercise capacity for 45 minutes during HD session 3 times/wk for a 6 month period


Treatment group 2
  • Ropinirole 0.25 mg in an identical capsule to that of placebo, 2 hours before bed daily for 6 months


Control group
  • Placebo (plain flour) in a similar capsule, to be taken 2 hours before bed daily for 6 months.


Co‐interventions
  • None

Outcomes
  • RLS severity using IRLSSG severity rating scale

  • Sleep quality: weekly sleep diary (adapted from University of Massachusetts Medical School)

  • QOL ‐ SF36

  • Lean body mass

  • Physical performance

  • Depression score using self rated Zung questionnaire

Notes
  • Funding source: Supported by the National and Community Funds of the Greek Ministry of Development ‐ General Secretariat of Research and Technology and by the European Social Fund

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised 2:1:1 but no details of how the randomisation was done
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Physical intervention versus drug (double blinded in the placebo versus ropinirole arms)
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Patients aware of the intervention in physical versus drug groups
Incomplete outcome data (attrition bias) 
 All outcomes Low risk One patient withdrew from each group (transplantation (2); chronic infection (1)
Selective reporting (reporting bias) Low risk All results of parameters assessed were clearly detailed. However, the reasons for dropouts were not specified; stated only that it was for reasons unrelated to the study
Other bias Low risk Government funding