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. 2017 Jun 21;2017(6):CD012700. doi: 10.1002/14651858.CD012700

Wigers 1996.

Methods 3 groups: aerobic exercises (AE); stress management; control
Length: 14 weeks; follow‐up: 4 years
Study design: randomized clinical trial with parallel groups
Participants Female:Male: 55:5
Age (years (SD)): 43 (9); 44 (12); 46 (9)
Inclusion: diagnosis of fibromyalgia (ACR 1990; Smythe 1979 + Yunus criteria 1981)
Exclusion: none
Duration of illness (years (SD)): 9 (5); 11 (10); 11 (9)
Interventions Aerobic exercise (n = 20): total duration (over 40 sessions) of aerobic exercise, focusing on the whole body and aimed at minimizing eccentric muscle strain, was 30 hours of active treatment. Frequency: 3/wk; Duration: 45' (23' music session comprising warming up and 2 peaks of high‐intensity training, each 3‐4', 15' aerobic games representing 2 high‐intensity periods 5‐6' with 4' calming down in between); Intensity: light to moderate (60%‐70% HRmax); Mode: movement to music and games
Stress management training (n = 20): 2 treatment groups of 10, with each totalling 20 sessions and 30 hours of active treatment; Frequency: 2/wk first 6 weeks, 1/wk remaining 8 weeks; Duration: 90'
Control (n = 20): continued treatments being used at baseline
For this review: All interventions were considered
Outcomes Pain (VAS), fatigue (VAS), CR max (ratio of max voluntary effort)
Other: tenderness (tender point count), global rating (self‐perceived change numerical rating scale), sleep (VAS), depression (VAS)
Measurements taken at 0, 7 weeks (mid‐test), 14 weeks (post‐test), and 4 years
Adherence to exercise protocols Monitoring methods: self‐monitored HR guidelines given to participants and attendance; adherence criteria: not stated; adherence: attendance rate 70%, 68%
Congruence with ACSM guidelines for aerobic training No, intensity too low, duration too short (only 18‐20’ at HR 60%‐70%)
Notes Country: Norway
Language: English
Study author contacted: no
Funding source/declaration of interest: Work was supported by The Research Council of Norway and The Norwegian Fibromyalgia Association
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "After baseline registration the patients were randomized [by drawing lots] into an AE group, a SMT group or a TAU group" (page 78)
Allocation concealment (selection bias) Unclear risk No details on allocation concealment were provided
Blinding of self reported outcome assessment (detection bias) 
 All outcomes High risk Self‐report instruments: pain intensity (VAS), fatigue (VAS)
Blinding of objective outcome assessment (detection bias) 
 All outcomes Low risk CR max (ratio of max voluntary effort). "Neither patients nor investigators had access to previous recordings on any test occasion" (page 78)
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "Patients were instructed not to reveal their group membership before treatment specific questions were asked at the very end of completion test. Neither patients nor investigators had access to previous recordings on any test occasion" (page 78)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data were analyzed by ITT
Selective reporting (reporting bias) Low risk Study protocol is not available but it is clear that the published reports include all expected outcomes
Other bias Low risk Study appears to be free of other sources of bias

ACR: American College of Rheumatology; AE: aerobic exercise; ANA: antinuclear antibody; CR submax: submaximal cardiorespiratory function; ESR: erythrocyte sedimentation rate; FIQ: Fibromyalgia Impact Questionnaire; FSS: Fatigue Severity Scale; FX: Flexibility; HR: heart rate; HRmax: maximum hear rate; HRR: heart rate reserve; ITT: intention to treat; LPA: lifestyle physical activity; RPE: rating of perceived exertion; RT: resistance exercise training; SBE: short bout exercise; SD: standard deviation; SF‐36: Short Form 36; VAS: visual aalogue scale; VO2: oxygen consumption