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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Su 2009.

Study characteristics
Methods Study design

  • Parallel RCT


Study dates

  • Duration of follow‐up: 12 weeks

  • Time frame: December 2006 to February 2007
Participants Study characteristics

  • Setting: single centre (Taiwan University Hospital)

  • Country: Taiwan

  • Inclusion criteria: 18 to 80 years; receiving 3, 3–5 hour HD sessions/week at the time of the study; received HD for at least 6 months

  • Exclusion criteria: hospitalised for any other reasons beside HD treatment; pregnant; had pacemaker


Baseline characteristics

  • Number (analysed/randomised): intervention group (31/34); control group (30/35)

  • Mean age ± SD (years): intervention group (61.07 ± 13.87); control group (58.57 ± 12.61)

  • Sex (M/F): intervention group (16/15); control group (17/13)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (5.7 ± 6.1); control group (4.9 ± 5.1)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (13/31); control group (6/30)

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported
Interventions Intervention clasification

  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group

  • Far infrared ray stimulation on acupoints


Control group

  • Heat pad therapy


Co‐interventions

  • Dialysis session
Outcomes Outcomes reported

  • Fatigue outcome measures used: validation data available

  • Heart rate variability analyser (assessed at 0, 4th, 8th, and 12th weeks)

    • Mean heart rate

    • Standard Deviation of Normal to Normal (SDNN) (> 30)

    • Root Mean Square of the Successive Differences (RMSSD) (> 20)

    • PSI (10 to 50, lower is better)

    • Frequency domain analysis

      • Total power

      • High frequency (0.15 to 0.40 Hz) (HF)

      • Low frequency (0.05 to 0.15 Hz) (LF)

      • Very low frequency (< 0.05Hz) (VLF)

      • LF/HF ratio (0.5 to 2.0)

      • ANS activity (enhancement is better)

      • ANS balance status (SNS: PNS = 3:2 or 2:3)

      • Fatigue index (LF, < 0.05 Hz)

      • Stress index (< 50)

      • Stress resistance (enhancement is better)

  • Changes in quality of life (assessed before and after treatment)

    • Taiwanese version of the WHOQOL‐BREF: assessed at week 0 and week 12

      • Overall QoL

      • General health

      • Physical

      • Psychological

      • Environmental

      • HRQoL

      • Satisfaction

      • Social relations
Notes Additional information

  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A randomised sample of 69 patients block in 4 was originally chosen."
Comment: Sequence generation methods were not reported in sufficient detail to permit judgement
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. However, interventions were different and investigators/participants could be aware of the treatment assigned
Blinding of outcome assessment (detection bias)
All outcomes High risk The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "During the study, 3 patients from the experimental group and 5 from the control group left for undisclosed reasons. Hence, the final count was 31 patients for Far infrared ray therapy and 30 patients for heat pad therapy."
Comment: 31/34 participants in the intervention group and 30/35 participants in the control group completed the study (> 5% lost to follow‐up, with difference between group). Reasons for discontinuations were reported
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, death and vascular access) were not reported
Other bias Unclear risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding and conflicts of interest were not reported