Participants and Randomization
dizziness, muscle soreness, headache, pain
ADVERSE EVENTS
Study information was provided to potential participants through reports in newspapers and the media, and individuals interested in participating in the study completed a small web-based survey. An apparently eligible participant was contacted for a telephone interview to further verify their medical history and ability to participate in the exercise program. The last step in recruiting participants was a physical examination conducted by a test leader (a physiotherapist) to ensure that the criteria for study participation were met. Informed written consent was obtained from all trial participants, and they filled out a baseline questionnaire. The participants in this noninferiority trial were very similar to the participants in the studies that established efficacy in NSE [A computer-based block randomization list stratified by sex was used for randomization to the 2 groups and allocated by a project team member (GP) not otherwise involved in any of the tests or treatments. After the test leader confirmed eligibility and baseline data were collected, GP sent the participant’s group allocation and contact details in a sealed, opaque envelope to the treating physiotherapist, who called the participant to book an appointment. The treating physiotherapist worked in a health care center near the participant’s home or workplace. This was aimed at facilitating the participant’s opportunity to take part in the study. An envelope was sent to the participants with information on their group allocation and a reminder to contact GP in 2 weeks if the physiotherapist had not called. The test leader was blinded to group allocation at baseline and at the 3- and 15-month follow-ups. The participant was blinded to group allocation when baseline data were collected. At 3 and 15 months, the participants reported adverse events to the test leader (defined as an unforeseen or dangerous reaction to the exercise intervention) or side effects (defined as commonly increased symptoms related to exercises, such as muscle soreness or temporally increased pain, dizziness, or headache for <2 weeks). An independent statistician analyzed the coded data.