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

Helmhout 2004.

Study characteristics
Methods Study design: RCT
Setting: Netherlands, occupational
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 81 (E1 = 41, E2 = 40)
Chronic LBP duration: Not specified (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 41
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 = 12 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 = 12 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Outcomes Core outcomes reported: Function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate)
Notes Conflicts of interest: Not reported
Funding source: Not reported
Other: Information modified for author contact
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done by means of a computer‐generated table.
Allocation concealment (selection bias) Low risk The study is an observer‐blinded trial.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described
Blinding of care provider (performance bias) High risk Same physio delivered both programmes.
Blinding of outcome assessment (detection bias)
All outcomes Low risk The training sessions and data collection (both from questionnaires and from strength measurements) were conducted by different people.
Incomplete outcome data (attrition bias)
All outcomes Low risk Six at post‐treatment, five more at six months, eight more at nine months = 62/81 total completed
Participants analysed in group allocated (attrition bias) High risk Analyses were done using all randomised participants who provided any post‐baseline data.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk Table 1 shows demographic properties of the population as well as baseline values for the outcome measures.
Co‐interventions avoided or similar (performance bias) Low risk Participants were asked to abandon other treatments In both groups; participants reported no co‐interventions during the 12‐week treatment period.
Compliance acceptable in all groups (performance bias) High risk The high‐intensity training group showed a higher treatment compliance than the low‐intensity training group: 29 participants (71%) in the high‐intensity training group, versus 19 participants (48%) in the low‐intensity training group
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.