Clinical trial NCT03562520: Toward Exercise as Medicine for Adolescents With Bipolar Disorder
Official title: Toward Exercise as Medicine for Adolescents With Bipolar Disorder: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Aerobic fitness
Aerobic exercise
Behavior change counseling
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: The Hospital for Sick Children
name: Mood Disorders Association of Ontario
First posted: 2018-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to bridge the knowledge-to-action gap regarding "exercise as medicine" for adolescents with bipolar disorder (BD). Numerous review articles attest to widespread recognition that aerobic exercise (AE) could be an important part of the treatment armamentarium to reduce the symptom burden, neurocognitive dysfunction, and cardiovascular disease (CVD) risk, improve quality of life (QOL), and even engage core biological treatment targets in BD. It appears self-evident that treatment for adolescents with BD, who experience high symptom burden, neurocognitive deficits, and increased CVD risk, should target their aerobic fitness (AF), yet there is not a single study in the world literature on this topic. Remarkably, there have been no intervention studies that specifically focus on aerobic exercise or that directly evaluate changes in AF in any BD age group. Overall physical activity is important, but focusing on AF offers unique potential benefits in terms of simultaneously ameliorating and enhancing mood, neurocognition, and cardiovascular health. Importantly, a recent American Heart Association (AHA) Scientific Statement confirms that it is the most aerobically unfit for whom even modest improvements in AF offer the greatest relative benefits. Nonetheless, important questions arise as to whether and how AF in this population can be improved. There is a clear and unmet need for effective behavior change counseling (BCC) interventions targeting AF that are tailored to the unique needs of adolescents with BD.

Detailed description: The overarching goal of this project is to advance the field in terms of BCC approaches to improving AF among adolescents with BD, a group for whom improvements in AF offer multiple parallel benefits. This project will serve as a preliminary feasibility study, a necessary step in the path toward a well-powered, randomized controlled trial (RCT). If exercise is to achieve the same status as other evidence-based treatments for adolescents with BD, it will be necessary to evaluate exercise with the same level of rigor as other interventions. A crucial first step toward the ultimate goal of an adequately powered RCT is to demonstrate that adolescents with BD will enroll in, and actively participate in, an intervention study that accurately reflects what would be required of participants in such a study.

Objective 1: Evaluate the feasibility of developing a 24-week BCC intervention, customized and personalized for adolescents with BD, focusing on increasing AF.

Objective 2: Evaluate the feasibility of implementing the 24-week BCC intervention.

Objective 3: Evaluate the feasibility of measuring the effects of the intervention.

Exploratory: Examine the impact on AF of a 24-week BCC intervention, customized and personalized for adolescents with BD. Related hypothesis-generating analyses will examine the impact of specific variables (e.g., mood, medications, exercise-induced feelings, specific BCC modules, changes in motivation and self-efficacy) on AF changes.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* 13-21 years old
* Meet diagnostic criteria for BD (using KSADS-PL)
* Report moderate-vigorous exercise \<150 minutes/week in the preceding 12 weeks
* Written clearance from primary care physician required

Exclusion Criteria:

* Unable to provide informed consent (e.g., severe psychosis, IQ\<80)
* Presence of hypo/hypertension and history of exercise induced and aggravated conditions that are contraindications to proceeding with the study (e.g., syncope, asthma)
* Known cardiac condition (e.g., conduction abnormality, congenital heart disease) or other active medical condition that precludes aerobic exercise
* Known respiratory condition that precludes aerobic exercise
* Known health condition of physiological impairment that would preclude participation in exercise
* Currently manic (PSR score of 5 or 6 on mania)

Primary outcomes:
measure: Barriers to participation using the Client Satisfaction Questionnaire
timeFrame: Week 12
measure: Barriers to participation using the Client Satisfaction Questionnaire
timeFrame: Week 24
measure: Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire
timeFrame: Week 12
measure: Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire
timeFrame: Week 24
measure: Percentage of target sample size enrolled
timeFrame: three years (At the end of study completion)
measure: Percentage of screened participants meeting inclusion criteria comparing number of participants screened to number of participants who meet inclusion criteria
timeFrame: Three years
measure: Barriers to recruitment
timeFrame: Three years
measure: Therapist adherence with behavior change counseling using the Behavior Change Counseling Index
timeFrame: three years
measure: Participant attendance
timeFrame: Week 0
measure: Participant attendance
timeFrame: Week 4
measure: Participant attendance
timeFrame: Week 8
measure: Participant attendance
timeFrame: Week 12
measure: Participant attendance
timeFrame: Week 1
measure: Participant attendance
timeFrame: Week 2
measure: Participant attendance
timeFrame: Week 3
measure: Participant attendance
timeFrame: Week 5
measure: Participant attendance
timeFrame: Week 6
measure: Participant attendance
timeFrame: Week 7
measure: Participant attendance
timeFrame: Week 9
measure: Participant attendance
timeFrame: Week 10
measure: Participant attendance
timeFrame: Week 11
measure: Participant attendance
timeFrame: Week 16
measure: Participant attendance
timeFrame: Week 20
measure: Participant completion of daily activity logs
timeFrame: three years
measure: Participant attendance
timeFrame: Week 1
measure: Percentage of participants who selected the exercise coaching optional module
timeFrame: three years
measure: Percentage of participants who selected the family focused counseling optional module
timeFrame: three years
measure: Percentage of participants who selected the peer support optional module
timeFrame: three years
measure: Percentage of participants who completed the 24 weeks of the study
timeFrame: three years
measure: Percentage of participants who completed the 12 week intervention
timeFrame: three years
measure: Percentage of participants who completed all aerobic fitness testing sessions
timeFrame: three years
measure: Percentage of sessions attended by each team member
timeFrame: three years
Secondary outcomes:
measure: Change in aerobic fitness using the Modified Bruce Protocol
timeFrame: From week 0 to week 12
measure: Change in aerobic fitness using the Modified Bruce Protocol
timeFrame: From week 12 to week 24
measure: Change in aerobic fitness using the Modified Canadian Aerobic Fitness Test
timeFrame: From week 2 to week 8
measure: Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)
timeFrame: baseline
measure: Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: baseline, week 12, week 24
measure: Brief Quality of Life in Bipolar Disorder (QoL.BD)
timeFrame: baseline, week 12, week 24
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline, week 12, week 24
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: At weeks 12 and 24
measure: The Stages of Change Questionnaire (SCQ)
timeFrame: baseline, week 4, week 8, week 12, and week 24
measure: Outcome Expectations for Exercise (OEE)
timeFrame: baseline, week 12, week 24
measure: Motives for Physical Activities Measure-Revised (MPAM-R)
timeFrame: baseline, week 12, week 24
measure: Behavioral Regulation in Exercise Questionnaire (BREQ-3)
timeFrame: baseline, week 12, week 24
measure: Exercise Self-Efficacy
timeFrame: baseline, week 12, week 24
measure: Quick Weight, Activity, Variety, and Excess Screener (WAVE)
timeFrame: baseline, week 12, week 24
measure: Drug Use Screening Inventory (DUSI)
timeFrame: baseline, week 12, week 24
measure: Stressful Life Events Schedule (SLES)
timeFrame: baseline, week 12, week 24
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, week 12, week 24
measure: Exercise-Induced Feeling Inventory (EIFI)
timeFrame: baseline, then pre- and post-aerobic fitness testing at weeks 0, 2, 8, 12, and 24
measure: Physical Activity Logs
timeFrame: Through study completion, an average of 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Senior Scientist, Psychiatrist
name: Benjamin I Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: