Interventions: description and fidelity assessments
This protocol is extracted from research article:
Enhancement of aerobic fitness improves social functioning in individuals with schizophrenia
Eur Arch Psychiatry Clin Neurosci, Jan 3, 2021; DOI: 10.1007/s00406-020-01220-0

All participants received standard psychiatric care over the course of the study, which included regular meetings with a psychiatrist, psychologists, social workers, and/or psychiatric nurses as determined by their pre-study individual treatment plan. Treatment schedules were determined for each participant by their clinical team and no attempts were made to inform or influence treatment.

Participants randomized to the AE intervention underwent a 12-week, 3 sessions/week, 1-hour AE training program informed by the American College of Sports Medicine and federal guidelines, which recommend 150 min of moderate-intensity AE per week. Moderate-intensity AE involves activities that expend 3.0–5.9 times the energy expended at rest and are broadly defined as activities in which the participant is able to talk while engaging in the activity. All AE sessions were held in a small gym located in the medical center. The AE equipment included two treadmill machines, a stationary bike, an elliptical machine, and two active-play video game systems (Xbox 360 Kinect, Microsoft) with whole-body exercise software [29, 46]. The AE sessions were led by a certified exercise trainer (B.S. degree in Therapeutic Recreation). The sessions opened with a 10-min trainer-led warm-up period, followed by 45-min AE using the equipment, and ended with a 5-min cool-down period. The trainer was present during all AE sessions for guidance and support, along with a research assistant who assisted with equipment set-up and collection of AE-related behavioral data.

Training fidelity was indexed by 1) the number of AE sessions attended over the 12-week program (maximum 36) and 2) in-session AE intensity. The latter was set for participants individually based on their maximal heart rate (HRmax), as determined during their baseline VO2 peak assessment. Target minimal AE intensity was set to 60% of HRmax in Week 1, 65% in Week 2, 70% in Week 3, and 75% in Weeks 4–12. In-session training intensity was monitored using Polar RS400 HR monitors (a wireless-enabled digital watch and chest strap) that participants wore during each session. The monitors were programmed to emit a soft beep when the participant’s HR was lower than the individually targeted AE intensity level, which cued the trainer to encourage the participant to achieve their individual target goal.

Data Analyses: Data analyses were conducted using IBM SPSS ver. 25. All tests were two-tailed and the significance level was α = .05. Determination of predictors of change in SF from baseline to 12-week follow-up was examined using three hierarchical step-wise regression analyses, using data from the PSRS, SLOF, and SANS as dependent variables. Change in aerobic fitness was entered in block 1 and demographic and clinical variables were entered in block 2. Clinical and demographic variables included age, sex, baseline antipsychotic medication use, baseline anxiety and depression scores, and baseline social network. Shapiro–Wilk tests indicated that the primary dependent variables were normally distributed. The AE and TAU intervention groups were compared using multivariate analyses of variance with a repeated-measures design, with time and group designated as within-subject and between-subject factors, respectively. We focused our analyses on study completers, but also present results using an intention-to-treat approach with baseline observations carried forward.

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