Toward Exercise as Medicine for Adolescents With Bipolar Disorder: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of participants who completed the 12 week intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Percentage of participants who completed the 12 week intervention
时间窗: three years
Percentage of target sample size enrolled
时间窗: three years (At the end of study completion)
Barriers to recruitment
时间窗: Three years
Qualitative assessment using phenomenological approach
Participant completion of daily activity logs
时间窗: three years
Number of daily activity logs completed for each participant
Percentage of participants who selected the exercise coaching optional module
时间窗: three years
Percentage of participants who selected the family focused counseling optional module
时间窗: three years
Percentage of participants who completed the 24 weeks of the study
时间窗: three years
Percentage of sessions attended by each team member
时间窗: three years
Barriers to participation using the Client Satisfaction Questionnaire
时间窗: Week 24
Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire
时间窗: Week 24
Percentage of participants who selected the peer support optional module
时间窗: three years
Percentage of screened participants meeting inclusion criteria comparing number of participants screened to number of participants who meet inclusion criteria
时间窗: Three years
Evaluating whether sample reflects clinical population in which exercise is an anticipated intervention
Therapist adherence with behavior change counseling using the Behavior Change Counseling Index
时间窗: three years
Percentage of participants who completed all aerobic fitness testing sessions
时间窗: three years
Participant attendance
时间窗: Week 1
Attendance at phone calls/texting sessions
次要结局
- Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)(baseline)
- Change in aerobic fitness using the Modified Bruce Protocol(From week 12 to week 24)
- Change in aerobic fitness using the Modified Canadian Aerobic Fitness Test(From week 2 to week 8)
- Quick Weight, Activity, Variety, and Excess Screener (WAVE)(baseline, week 12, week 24)
- Longitudinal Interval Follow-up Evaluation (LIFE)(baseline, week 12, week 24)
- Brief Quality of Life in Bipolar Disorder (QoL.BD)(baseline, week 12, week 24)
- Behavioral Regulation in Exercise Questionnaire (BREQ-3)(baseline, week 12, week 24)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, week 12, week 24)
- Physical Activity Logs(Through study completion, an average of 24 weeks)
- Motives for Physical Activities Measure-Revised (MPAM-R)(baseline, week 12, week 24)
- Exercise Self-Efficacy(baseline, week 12, week 24)
- Stressful Life Events Schedule (SLES)(baseline, week 12, week 24)
- 36-Item Short Form Health Survey (SF-36)(baseline, week 12, week 24)
- Client Satisfaction Questionnaire-8 (CSQ-8)(At weeks 12 and 24)
- The Stages of Change Questionnaire (SCQ)(baseline, week 4, week 8, week 12, and week 24)
- Outcome Expectations for Exercise (OEE)(baseline, week 12, week 24)
- Exercise-Induced Feeling Inventory (EIFI)(baseline, then pre- and post-aerobic fitness testing at weeks 0, 2, 8, 12, and 24)
- Drug Use Screening Inventory (DUSI)(baseline, week 12, week 24)
研究者
Dr. Benjamin Goldstein
Senior Scientist, Psychiatrist
Sunnybrook Health Sciences Centre