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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Harts 2008.

Study characteristics
Methods Study design: RCT
Setting: Netherlands, occupational
Exercise groups: 2
Comparison groups: 1
Participants Number of participants: 65 (E1 = 23, E2 = 21, C1 = 21)
Chronic LBP duration: Not specified (long)
Neurological/radicular symptoms: Not specified
Mean age (years): 42
Sex (female): 0%
Interventions Exercise Group 1 (E1): Progressive resistance exercises for the isolated lumbar extensor muscle groups (load set at 50% of maximal isometric extension strength of participant at baseline); type = strengthening; duration = 8 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): Nonprogressive low‐intensity resistance exercise programme (load set at a maximum of 20% of the maximal isometric extension strength of participant at baseline); type = strengthening; duration = 8 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (waiting‐list group)
Outcomes Core outcomes reported: Function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 8 weeks (short)
Notes Conflicts of interest: Not reported
Funding source: Not reported
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Concealed randomisation was performed by means of a computer‐generated table of random numbers with a block size of six.
Allocation concealment (selection bias) Low risk Randomised, three‐arm trial with concealed allocation, assessor blinding
Blinding of participants and personnel (performance bias)
All outcomes High risk Assumed not possible
Blinding of care provider (performance bias) High risk Assumed not possible
Blinding of outcome assessment (detection bias)
All outcomes Low risk Measurement of outcomes was carried out by the principal investigator or research assistants who were not aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes Low risk Six participants withdrew during the intervention period.
Participants analysed in group allocated (attrition bias) Unclear risk All analyses were carried out according to the intention‐to‐treat principle.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk There were only minor differences in demographic characteristics.
Co‐interventions avoided or similar (performance bias) Low risk No co‐interventions were reported during both the intervention and the waiting‐list period.
Compliance acceptable in all groups (performance bias) Low risk A total of 31 participants received the high‐intensity strengthening programme.
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.