The trial is conducted at three hospitals in Sweden: one
in the county of Västerbotten (Norrlands University
Hospital, Umeå), one in the region of Stockholm
(Karolinska University Hospital, Huddinge) and one in
the region of Västernorrland (Örnsköldsvik Hospital,
Recruitment of eligible patients fulfilling inclusion criteria
Reasons for exclusion
Not meeting inclusion criteria
Declined to participate
Other reasons
Outcome measurement directly after end of intervention period
Three occasions during two weeks
Blinded outcome assessors
Allocation to intervention group
HRSLE and patient education
8 week intervention period
3 training sessions per week + 4 education sessions
Allocation to control group
Patient education
8 week intervention period
4 education sessions
Allocation
Post-test
Randomization
Enrollment
Baseline and inclusion measurements
Four occasions during three weeks
Reasons for exclusion
Not meeting inclusion criteria
Declined to participate
Other reasons
Örnsköldsvik Hospital,
Örnsköldsvik
Karolinska University Hospital,
Huddinge
Norrlands University Hospital,
Umeå
Analysis
Analysis of data
Analyses of primary and secondary outcome measurements will
include all randomized patients analyzed by original assigned group
Pre-test
Stratification by center and gender
Figure 1 Consolidate standards of reporting trials (CONSORT) flow diagram of trial design.
Nyberg et al. Trials 2012, 13:114 Page 3 of 14
http://www.trialsjournal.com/content/13/1/114
Örnsköldsvik). Recruitment of participants and collection
of data started May 2011.