Hayney 2014.

Methods	AIMS AND OBJECTIVES To compare influenza vaccine responses due to meditation or exercise training with controls STUDY DESIGN Parallel RCT DATES OF STUDY IMPLEMENTATION June 2012 to June 2016 STUDY DURATION 20 weeks SETTING, NUMBER OF CENTRES University of Wisconsin Health Sports Medicine Center; single centre
Participants	INCLUSION CRITERIA Participants aged 50 years or older, willing to undertake any of the 3 randomisation outcomes, and reporting either 2 or more colds in the last 12 months or an average of 1 or more colds per year EXCLUSION CRITERIA "...previous training or current practice of meditation, moderate exercise at least 2 times a week or vigorous exercise at least 1 time a week, and a score of less than 24 points on the Folstein Mini‐Mental State Examination or more than 14 points on the 9‐item Patient Health Questionnaire (PHQ‐9) depression screen; immunodeficiency, autoimmune, or malignant disease; or prior allergic reaction to influenza vaccine or egg allergy." RECRUITMENT N RANDOMISED 154 participants N COMPLETED 149 participants GENDER 21 men, 133 women AGE Mean age 59.26 ± 8.87 years
Interventions	DESCRIPTION OF INTERVENTION "The exercise program was designed and led by exercise physiologist at was matched to the meditation program in terms of duration (8 weeks), contact time (weekly 2.5 hour group sessions), home practice (45 min per day), and location. Borg’s Rating of Perceived Exertion was used to guide participants toward moderate intensity, sustained exercise, with a target rating of 12 to 16 points on the 6‐to‐20 point scale." DELIVERY Senior exercise physiology staff CONTROL GROUP Wait‐list control
Outcomes	PRESPECIFIED OUTCOME MEASURES Influenza antibody responses post‐immunisation; Seroprotection at least 160 HA U and measures of well‐being GROUP ALLOCATION Exercise: 47 participants; Meditation: 51 participants; Control: 51 participants FOLLOW‐UP PERIOD 3 months
Notes	TRIAL REGISTRATION NCT01057771 ETHICS Not reported FUNDING Supported by a grant from the National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (1R01AT004313); and by a grant UL1RR025011 from the Clinical and Translational Science Award (CTSA) Program of the National Center for Research Resources, National Institutes of Health. Aleksandra Zgierska is supported by grant K23 AA017508 from National Institute on Alcohol Abuse and Alcoholism at NIH CONFLICTS OF INTEREST Bruce Barrett was previously supported by career development grants from the National Center for Complementary and Alternative Medicine (K23AT00051) and from the Robert Wood Johnson Foundation, both of which were essential for developing the methodology and infrastructure for recruiting and monitoring research subjects, and for assessing their acute respiratory infections
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"SAS software was used to generate 165 unique identification numbers in balanced blocks of 3"
Allocation concealment (selection bias)	Low risk	"Codes were concealed envelopes, which were opened after consent to indicate allocation"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants were not blind to exercise or control
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The laboratory staff performing the HIA used the standard micro titre techniques and was blinded to participant status"
Incomplete outcome data (attrition bias) All outcomes	Low risk	3% dropout
Selective reporting (reporting bias)	Low risk	Outcomes proposed in the protocol were included in published results
Other bias	Low risk	None found