Toward Exercise as Medicine for Adolescents With Bipolar Disorder (TEAM-BD)

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Bipolar Disorder

Treatments: Behavioral: Behavior change counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03562520

007-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Adolescents with bipolar disorder

Experimental group

Description:

Forty adolescents (aged 13-21) with BD (type I, II, or not otherwise specified/other specified and related disorder) will be enrolled in the behavior change counseling intervention.

Treatment:

Behavioral: Behavior change counseling