Trial Outcomes & Findings for Exercise and Markers of Medial Temporal Health in Youth At-risk for Psychosis (NCT NCT02155699)

Last Updated: 2024-04-02

Results Overview

Medial temporal structures (hippocampus and parahippocampal gyrus) will be delineated automatically using the FMRIB's Integrated Registration and Segmentation Tool algorithm within the FMRIB's Software Library (FSL) image-processing suite. Secondly, the structures will be evaluated with vertex analyses (assessing changes in shape post trial on a per-vertex basis), which will also be carried out utilizing FIRST. Shape/appearance models used in FIRST are constructed from manually segmented images provided by the Center for Morphometric Analysis (CMA, Boston). This approach is different from using a whole-structure summary measure like volume, as it allows visualization of the region of the shape that is changing as well as the type of shape change.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

pre-trial, post-trial (3-months)

Results posted on

2024-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	65% of V02 Max, 3x Per Week, 3 Months - Dosage/Tolerance Study 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week Initial study that is a separate sample from the waitlist and HIIT RCT groups	85% of VO2 Max, 2x Per Week, 3 Months - Study 1 Dosage 85% of VO2 Max, 2x per week, 3 months Exercise 2: 85% intensity and 3 sessions per peek Initial tolarance study with separate participants from the RCT groups.	Waitlist - RCT Study Waitlist (three months no intervention) Group is a part of RCT study and a separate sample than the dosage and tolerance initial study sample.	High Impact Interval Exercise 80%/95% VO2 Max RCT For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins. This protocol was adapted from findings in the open-label pilot study (groups 1 (65%) and 2(85%)), which suggested that fewer sessions and higher intensity of exercise were needed.
Overall Study STARTED	7	5	20	18
Overall Study COMPLETED	7	2	12	13
Overall Study NOT COMPLETED	0	3	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	85% of VO2 Max, 2x Per Week, 3 Months - Study 1 Dosage 85% of VO2 Max, 2x per week, 3 months Exercise 2: 85% intensity and 3 sessions per peek Initial tolarance study with separate participants from the RCT groups.	Waitlist - RCT Study Waitlist (three months no intervention) Group is a part of RCT study and a separate sample than the dosage and tolerance initial study sample.	High Impact Interval Exercise 80%/95% VO2 Max RCT For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins. This protocol was adapted from findings in the open-label pilot study (groups 1 (65%) and 2(85%)), which suggested that fewer sessions and higher intensity of exercise were needed.
Overall Study Withdrawal by Subject	3	6	1
Overall Study Lost to Follow-up	0	0	3
Overall Study Emergence of Psychosis or Substance disorder during protocol	0	2	1

Baseline Characteristics

Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise - High Impact Interval 95% VO2 Max -32 Week n=18 Participants The exercise group participants completed a 3-month exercise treatment twice a week at moderate to intense levels of aerobic exercise (24 sessions over 12 weeks). To limit the perceived barriers to sessions,15 participants were provided with free transportation to the sessions, after the session access to healthy snacks and refreshments were provided. Participants received paid compensation after each session. All sessions were conducted as one-on-one sessions by the same exercise physiologist under the supervision of a physician to build rapport with participants and ensure consistency in the protocol. These high-intensity interval exercise sessions were tailored to the individual's exercise fitness level based on the baseline VO2max assessment. For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins. This protocol was adapted from findings in the open-label pilot study, which suggested that fewer sessions and higher intensity of exercise were needed. After the exercise intervention, participants repeated the baseline visit again with separate study staff who were blinded to their exercise intervention status.	Wait List n=20 Participants These individuals completed cognitive assessment, clinical assessment, and MRIs at baseline and follow up, but were not provided with exercise intervention. All assessors were blind to intervention status.	Dosage Study 85% Vigorous n=5 Participants Participants were randomly assigned to 1 of 2 conditions: moderate or vigorous. The moderate condition required exercise 2 days a week at 65% of their Vo 2max for a total of 24 sessions. of 36 sessions. Participants wore a Polar FT1 heart rate monitor (https://www.polar.com/us-en) throughout each exercise session, and an exercise physiologist monitored the participant's exercise in order to keep the participant's heart rate at ± 5% of the prescribed target intensity. Initial exercise sessions lasted 15 minutes at 55% of Vo 2max intensity and were gradually increased to 30 minutes and target intensity within the first 3 weeks. The remaining exercise sessions lasted 30 minutes and were conducted at prescribed exercise intensity. Participants were given the choice to ride stationary bikes, run/walk on treadmills, or use elliptical machines at each session.	Dosage Study 65%Moderate n=7 Participants Participants were randomly assigned to 1 of 2 conditions: moderate or vigorous. The moderate condition required exercise 2 days a week at 65% of their Vo 2max for a total of 24 sessions. Participants wore a Polar FT1 heart rate monitor (https://www.polar.com/us-en) throughout each exercise session, and an exercise physiologist monitored the participant's exercise in order to keep the participant's heart rate at ± 5% of the prescribed target intensity. Initial exercise sessions lasted 15 minutes at 55% of Vo 2max intensity and were gradually increased to 30 minutes and target intensity within the first 3 weeks. The remaining exercise sessions lasted 30 minutes and were conducted at prescribed exercise intensity. Participants were given the choice to ride stationary bikes, run/walk on treadmills, or use elliptical machines at each session.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=18 Participants	20 Participants n=20 Participants	5 Participants n=5 Participants	7 Participants n=7 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=50 Participants
Age, Continuous	21.15 years STANDARD_DEVIATION 1.75 • n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	21.57 years STANDARD_DEVIATION 1.78 • n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	19.2 years STANDARD_DEVIATION 1.30 • n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	19.6 years STANDARD_DEVIATION 1.13 • n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	21.36 years STANDARD_DEVIATION 1.7 • n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Sex: Female, Male Female	11 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	3 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	2 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	4 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	20 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Sex: Female, Male Male	2 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	9 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	3 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	3 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	17 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	1 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	1 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) Asian	1 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	2 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	1 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	4 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) Black or African American	7 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	1 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	8 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) White	3 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	8 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	3 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	7 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	21 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) More than one race	2 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	1 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	3 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.	0 Participants n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, 7 withdrew (1 exercise/6 waitlist); 3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded, 13 withdrew/excluded in RCT; final RCT sample n=25. Across studies, 16 excluded. Final n=37.
Region of Enrollment United States	18 participants n=18 Participants	20 participants n=20 Participants	5 participants n=5 Participants	7 participants n=7 Participants	50 participants n=50 Participants
Wide Range Achievement Test (WRAT) reading subscale	105.83 Standard Score STANDARD_DEVIATION 13.38 • n=13 Participants • RCT study dropout/excluded n=13; Dose study cognition was assessed with the MATRICS Consensus Cognitive Battery composite using a t-score (0=population mean, standard deviation=10), and Wide Range Achievement Test (WRAT) Reading Subscale in the RCT study using a standard score (100=population mean, standard deviation=15). On both measures, higher scores indicate better cognitive performance.	114.8 Standard Score STANDARD_DEVIATION 14.97 • n=12 Participants • RCT study dropout/excluded n=13; Dose study cognition was assessed with the MATRICS Consensus Cognitive Battery composite using a t-score (0=population mean, standard deviation=10), and Wide Range Achievement Test (WRAT) Reading Subscale in the RCT study using a standard score (100=population mean, standard deviation=15). On both measures, higher scores indicate better cognitive performance.	50.2 Standard Score STANDARD_DEVIATION 7.92 • n=5 Participants • RCT study dropout/excluded n=13; Dose study cognition was assessed with the MATRICS Consensus Cognitive Battery composite using a t-score (0=population mean, standard deviation=10), and Wide Range Achievement Test (WRAT) Reading Subscale in the RCT study using a standard score (100=population mean, standard deviation=15). On both measures, higher scores indicate better cognitive performance.	48.5 Standard Score STANDARD_DEVIATION 7.4 • n=7 Participants • RCT study dropout/excluded n=13; Dose study cognition was assessed with the MATRICS Consensus Cognitive Battery composite using a t-score (0=population mean, standard deviation=10), and Wide Range Achievement Test (WRAT) Reading Subscale in the RCT study using a standard score (100=population mean, standard deviation=15). On both measures, higher scores indicate better cognitive performance.	110.315 Standard Score STANDARD_DEVIATION 14.17 • n=37 Participants • RCT study dropout/excluded n=13; Dose study cognition was assessed with the MATRICS Consensus Cognitive Battery composite using a t-score (0=population mean, standard deviation=10), and Wide Range Achievement Test (WRAT) Reading Subscale in the RCT study using a standard score (100=population mean, standard deviation=15). On both measures, higher scores indicate better cognitive performance.
Relational and Item-Specific Encoding Task	2.75 recollection accuracy score STANDARD_DEVIATION 0.45 • n=13 Participants • RCT study dropout/excluded n=13 (see above); Dosage study working memory was assessed with the MATRICS Consensus Cognitive Battery working memory subscale using a t-score (0=population mean, standard deviation=10) and Relational and Item-Specific Encoding Task accuracy score in the RCT study using a task specific accuracy (the proportion of false alarms from the proportion of hits; range 0-100%). On both measures higher scores indicate better working memory performance.	3.73 recollection accuracy score STANDARD_DEVIATION 0.44 • n=12 Participants • RCT study dropout/excluded n=13 (see above); Dosage study working memory was assessed with the MATRICS Consensus Cognitive Battery working memory subscale using a t-score (0=population mean, standard deviation=10) and Relational and Item-Specific Encoding Task accuracy score in the RCT study using a task specific accuracy (the proportion of false alarms from the proportion of hits; range 0-100%). On both measures higher scores indicate better working memory performance.	47.2 recollection accuracy score STANDARD_DEVIATION 6.80 • n=5 Participants • RCT study dropout/excluded n=13 (see above); Dosage study working memory was assessed with the MATRICS Consensus Cognitive Battery working memory subscale using a t-score (0=population mean, standard deviation=10) and Relational and Item-Specific Encoding Task accuracy score in the RCT study using a task specific accuracy (the proportion of false alarms from the proportion of hits; range 0-100%). On both measures higher scores indicate better working memory performance.	49.7 recollection accuracy score STANDARD_DEVIATION 7.57 • n=7 Participants • RCT study dropout/excluded n=13 (see above); Dosage study working memory was assessed with the MATRICS Consensus Cognitive Battery working memory subscale using a t-score (0=population mean, standard deviation=10) and Relational and Item-Specific Encoding Task accuracy score in the RCT study using a task specific accuracy (the proportion of false alarms from the proportion of hits; range 0-100%). On both measures higher scores indicate better working memory performance.	3.24 recollection accuracy score STANDARD_DEVIATION .44 • n=37 Participants • RCT study dropout/excluded n=13 (see above); Dosage study working memory was assessed with the MATRICS Consensus Cognitive Battery working memory subscale using a t-score (0=population mean, standard deviation=10) and Relational and Item-Specific Encoding Task accuracy score in the RCT study using a task specific accuracy (the proportion of false alarms from the proportion of hits; range 0-100%). On both measures higher scores indicate better working memory performance.
VO2max assessment modified Balke protocol	33.92 ml/kg/min STANDARD_DEVIATION 7.4 • n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. VO2 Max is calculated as ratio (mL/kg/min) during exercise; higher VO2 max indicates greater cardiovascular health.	31.48 ml/kg/min STANDARD_DEVIATION 8.87 • n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. VO2 Max is calculated as ratio (mL/kg/min) during exercise; higher VO2 max indicates greater cardiovascular health.	42 ml/kg/min STANDARD_DEVIATION 4.13 • n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. VO2 Max is calculated as ratio (mL/kg/min) during exercise; higher VO2 max indicates greater cardiovascular health.	40.5 ml/kg/min STANDARD_DEVIATION 4.52 • n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. VO2 Max is calculated as ratio (mL/kg/min) during exercise; higher VO2 max indicates greater cardiovascular health.	32.7 ml/kg/min STANDARD_DEVIATION 8.14 • n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. VO2 Max is calculated as ratio (mL/kg/min) during exercise; higher VO2 max indicates greater cardiovascular health.
Structured Interview for Psychosis-Risk Syndromes (SIPS)	12.08 Symptom Severity Score STANDARD_DEVIATION 3.52 • n=13 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. Structured Interview for Psychosis Risk Syndrome (SIPS) score is calculated as a composite of the frequency and severity of psychosis symptoms, assesses uncommon experiences there is not a relevant population reference. A higher score indicates a higher number, frequency, and/or severity of symptoms.	13.50 Symptom Severity Score STANDARD_DEVIATION 3.90 • n=12 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. Structured Interview for Psychosis Risk Syndrome (SIPS) score is calculated as a composite of the frequency and severity of psychosis symptoms, assesses uncommon experiences there is not a relevant population reference. A higher score indicates a higher number, frequency, and/or severity of symptoms.	11.2 Symptom Severity Score STANDARD_DEVIATION 5.89 • n=5 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. Structured Interview for Psychosis Risk Syndrome (SIPS) score is calculated as a composite of the frequency and severity of psychosis symptoms, assesses uncommon experiences there is not a relevant population reference. A higher score indicates a higher number, frequency, and/or severity of symptoms.	13.1 Symptom Severity Score STANDARD_DEVIATION 4.38 • n=7 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. Structured Interview for Psychosis Risk Syndrome (SIPS) score is calculated as a composite of the frequency and severity of psychosis symptoms, assesses uncommon experiences there is not a relevant population reference. A higher score indicates a higher number, frequency, and/or severity of symptoms.	13.15 Symptom Severity Score STANDARD_DEVIATION 3.71 • n=37 Participants • Dose study initial sample n=12; RCT study initial sample n=38, n=13 withdrew/excluded; final RCT sample n=25. Total across studies n=37. Structured Interview for Psychosis Risk Syndrome (SIPS) score is calculated as a composite of the frequency and severity of psychosis symptoms, assesses uncommon experiences there is not a relevant population reference. A higher score indicates a higher number, frequency, and/or severity of symptoms.

PRIMARY outcome

Timeframe: pre-trial, post-trial (3-months)

Population: Withdrew/excluded 3 Dosage (Exercise 2 group); 13 RCT (3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded); Final n=34; Change in hippocampal volume is reported below. On both measures negative scores indicate decreased hippocampal volumes over the study period.

Outcome measures

Outcome measures
Measure	Dosage Study Exercise n=7 Participants Due to small final sample size both groups are collapsed into one. 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Doseage Study Exercise 2 n=2 Participants Due to small final sample size both groups are collapsed into one. 85% of VO2 Max, 2x per week, 3 months Exercise 2: 85% intensity and 3 sessions per peek	RCT High Impact Interval Exercise n=13 Participants The exercise group participants completed a 3-month exercise treatment twice a week at moderate to intense levels of aerobic exercise (24 sessions over 12 weeks). . For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins.	RCT Wait List n=12 Participants Completed pre/post measures with no intervention in the intervening three months	RCT Waitlist Pre-Intervention This is the baseline measure of the group with no exercise intervention.	RCT Waitlist Post-Intervention Period This is the group with no exercise intervention 3 months later.	Pre-Intervention Moderate Dosage - 65% 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Post-Intervention Moderate Dosage - 65% 65% of V02 max , 3 x per week 3 months
Brain Volume	19.8 Change in mm cubed (baseline -followup) Standard Deviation 50.8	54.8 Change in mm cubed (baseline -followup) Standard Deviation 323	-0.489 Change in mm cubed (baseline -followup) Standard Deviation 0.104	-6.28 Change in mm cubed (baseline -followup) Standard Deviation 1.95	—	—	—	—

SECONDARY outcome

Timeframe: pre-trial, post-trial (3-months)

Population: Because there were few participants who completed the vigorous condition, subsequent analyses of the exercise intervention collapsed across conditions - Exercise 1 is all exercise Pre and Exercise 2 is all exercise post - Arm 2 has pre/Post for intervention group and wait list group listed for the RISE measure

Working Memory Assessment - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery working memory subscale - a higher score indicates working memory better performance. The Relational and Item-Specific Encoding task includes visual object representations of word stimuli. Subjects make a two-button "yes/no" response to indicate whether items in each pair had been presented "together."To prevent additional encoding of the relational object pairs the item recognition task precedes the associated recognition task. Higher scores reflect the familiarity and recollection performance as well as hit rates and false alarm rates following encoding - better performance. MATRICS Consensus Cognitive Battery working memory subscale using a t-score (0=population mean, standard deviation=10) and Relational and Item-Specific Encoding Task accuracy score in the RCT study using a task specific accuracy (d prime range; 0-100%).

Outcome measures

Outcome measures
Measure	Dosage Study Exercise n=2 Participants Due to small final sample size both groups are collapsed into one. 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Doseage Study Exercise 2 n=2 Participants Due to small final sample size both groups are collapsed into one. 85% of VO2 Max, 2x per week, 3 months Exercise 2: 85% intensity and 3 sessions per peek	RCT High Impact Interval Exercise n=13 Participants The exercise group participants completed a 3-month exercise treatment twice a week at moderate to intense levels of aerobic exercise (24 sessions over 12 weeks). . For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins.	RCT Wait List n=13 Participants Completed pre/post measures with no intervention in the intervening three months	RCT Waitlist Pre-Intervention n=13 Participants This is the baseline measure of the group with no exercise intervention.	RCT Waitlist Post-Intervention Period n=13 Participants This is the group with no exercise intervention 3 months later.	Pre-Intervention Moderate Dosage - 65% n=7 Participants 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Post-Intervention Moderate Dosage - 65% n=7 Participants 65% of V02 max , 3 x per week 3 months
Working Memory Assessment	47.5 Composite tscore/ RiSE Score Standard Deviation 14.8	53 Composite tscore/ RiSE Score Standard Deviation 19.8	2.75 Composite tscore/ RiSE Score Standard Deviation .45	3.00 Composite tscore/ RiSE Score Standard Deviation .57	3.73 Composite tscore/ RiSE Score Standard Deviation .44	3.13 Composite tscore/ RiSE Score Standard Deviation .56	48.5 Composite tscore/ RiSE Score Standard Deviation 7.40	52.9 Composite tscore/ RiSE Score Standard Deviation 6.91

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-trial, post-trial (3-months)

Population: Withdrew/excluded 3 Dosage (85% VO2 Max group); 13 RCT (3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded); Final n=34

The Structured Interview for Prodromal Symptoms (SIPS) will be administered to formally assess attenuated positive symptoms after inclusion in the study. It will also be administered post-trial to track changes in clinical symptoms post intervention trial. The SIPS rates the severity of relevant dimensions including positive symptoms along a 7-point scale ranging from absent (0) to severe and psychotic (6) across five symptom categories, resulting in a score that ranges from 0 (no positive symptoms) to 30 (psychosis along all symptoms dimensions).

Outcome measures

Outcome measures
Measure	Dosage Study Exercise n=7 Participants Due to small final sample size both groups are collapsed into one. 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Doseage Study Exercise 2 n=7 Participants Due to small final sample size both groups are collapsed into one. 85% of VO2 Max, 2x per week, 3 months Exercise 2: 85% intensity and 3 sessions per peek	RCT High Impact Interval Exercise n=13 Participants The exercise group participants completed a 3-month exercise treatment twice a week at moderate to intense levels of aerobic exercise (24 sessions over 12 weeks). . For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins.	RCT Wait List n=12 Participants Completed pre/post measures with no intervention in the intervening three months	RCT Waitlist Pre-Intervention n=13 Participants This is the baseline measure of the group with no exercise intervention.	RCT Waitlist Post-Intervention Period n=12 Participants This is the group with no exercise intervention 3 months later.	Pre-Intervention Moderate Dosage - 65% n=2 Participants 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Post-Intervention Moderate Dosage - 65% n=2 Participants 65% of V02 max , 3 x per week 3 months
Attenuated Psychosis Positive Symptom Subscales	13.1 score on a scale Standard Deviation 4.38	9.29 score on a scale Standard Deviation 3.82	12.08 score on a scale Standard Deviation 3.52	13.50 score on a scale Standard Deviation 3.90	8 score on a scale Standard Deviation 3.46	11.38 score on a scale Standard Deviation 3.82	14 score on a scale Standard Deviation 8.49	12 score on a scale Standard Deviation 5.66

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-trial, post-trial (3 months)

Population: Because there were few participants (n=9); outcome data combine moderate (n=2) \& vigorous (n=7) groups; total outcome sample n=9; 13 RCT (3 were excluded from the exercise group for not completing all 24 trials, 2 developed substance use disorders after baseline, 1 waitlist converted to a psychosis diagnosis during the protocol and was excluded); Final n=34

VO2max was assessed via a modified Balke protocol by an exercise physiologist under the supervision of a physician. In this modified Balke protocol, the treadmill speed was individualized in a procedure to elicit 70% of the age-predicted max heart rate and ratings of a "somewhat hard" perceived exertion (RPE). Then, the speed of the treadmill remained the same throughout the test, but the incline of the treadmill belt increased 2% every 2 min (or 2.5% for speeds 6 mph or greater) to exhaustion. Tests generally lasted 8-12 minutes to attain the recommended target for VO2max testing. Measures indicate cardiovascular health with higher scores indicating greater health.

Outcome measures

Outcome measures
Measure	Dosage Study Exercise n=7 Participants Due to small final sample size both groups are collapsed into one. 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Doseage Study Exercise 2 n=7 Participants Due to small final sample size both groups are collapsed into one. 85% of VO2 Max, 2x per week, 3 months Exercise 2: 85% intensity and 3 sessions per peek	RCT High Impact Interval Exercise n=2 Participants The exercise group participants completed a 3-month exercise treatment twice a week at moderate to intense levels of aerobic exercise (24 sessions over 12 weeks). . For initial tolerance, the treadmill exercise intensity was set to elicit 55% of the participant's VO2max which was increased to 80% gradually over the first 3 weeks. During the remainder of the trial (21 weeks), the 2 weekly, treadmill sessions were designed to elicit 80% of VO2max for the majority of the time with 1-min high-intensity intervals at 95% of VO2max, every 10 minutes for 3 repetitions for a total of 30 mins.	RCT Wait List n=2 Participants Completed pre/post measures with no intervention in the intervening three months	RCT Waitlist Pre-Intervention n=13 Participants This is the baseline measure of the group with no exercise intervention.	RCT Waitlist Post-Intervention Period n=13 Participants This is the group with no exercise intervention 3 months later.	Pre-Intervention Moderate Dosage - 65% n=12 Participants 65% of V02 Max, 3x per week, 3 months Exercise 1: 65% of VO2max and 2 sessions per week	Post-Intervention Moderate Dosage - 65% n=12 Participants 65% of V02 max , 3 x per week 3 months
Aerobic Fitness	40.5 ml/kg/min Standard Deviation 10.9	39.0 ml/kg/min Standard Deviation 10.1	40.2 ml/kg/min Standard Deviation 6.15	41.2 ml/kg/min Standard Deviation 0.495	33.92 ml/kg/min Standard Deviation 7.4	38.2 ml/kg/min Standard Deviation 7.8	31.48 ml/kg/min Standard Deviation 7.8	32.97 ml/kg/min Standard Deviation 7.2

Adverse Events

Dosage Study: Exercise - Moderate Intensity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dosage Study: Exercise High Intensity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RCT: Exercise - High Impact Interval 95%/80% VO2 Max -32 Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RCT: Wait List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vijay A Mittal

Northwestern University

Phone: 847-467-3880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place