Project MOVE Bipolar
2026年8月12日 更新者：Butler Hospital
Initiating and Maintaining Physical Activity in Individuals With Bipolar Disorder
The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
- brief advice (BA) to exercise (control condition);
- BA + supervised & home-based exercise (SHE) + health education (HE) contact control; and
- BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).
The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness. The investigators will also compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels. The investigators will also compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase.
調査の概要
詳細な説明
The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
- brief advice (BA) to exercise (control condition);
- BA + supervised & home-based exercise (SHE)+health education (HE) contact control; and
- BA+SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).
There are two phases for participants: intervention phase (3 months), which consists of intensive contact, and the follow-up phase (3 months). BA will consist of one, 45-minute session about public health recommendations, and strategies for getting started. SHE will be a 12-week intervention consisting of 1x/week supervised exercise plus exercise prescriptions for home-based exercise with the goal of gradually achieving the public health recommendation of 150 minutes/week of moderate-to-vigorous physical activity (MVPA), CBEX and HE sessions will be individual, 30-minute, weekly sessions during the intervention phase. CBEX will address barriers to physical activity that are particularly pronounced in depression -i.e., anhedonia, decreased motivation, and decreased energy, as well as poor problem-solving skills. During the follow-up phase, groups who received SHE during the intervention phase will receive brief, monthly phone check-ins from an exercise specialist.
Primary Aims:
- To assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness in order to inform future steps in this research (i.e., a larger scale clinical trial).
- To compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels.
- To compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase (aim #2).
研究の種類
介入
入学 (実際)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Rhode Island
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Providence、Rhode Island、アメリカ、02906
- Butler Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion criteria:
- Low-active, i.e., have not participated regularly (more than 6 weeks in the last 12 weeks) in moderate-to-vigorous physical activity (MVPA) for no greater than 90 minutes per week for the past 12 weeks AND is not enrolled in a current program designed to increase physical activity (such as Miriam weight loss program, intensive physical therapy, or other research projects related to physical activity)
- Able to walk one mile. The cardiorespiratory fitness test requires the participant to walk one mile.
- Medically cleared for MVPA, documented by a note from their primary care provider.
- No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will exclude individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also exclude individuals who are planning a surgery in the next 9 months and those with dementia.
- Meet criteria for BDI, BDII or BD NOS assessed by relevant modules of the Structured Interview for DSM Disorders (SCID)
- Range scores for depression. Participants must have a QIDS score that is ≤20.
- No Current/Recent Manic/Hypomanic Episode. Participants cannot meet criteria for mania or Hypomania in the past month as assessed by the relevant module of the SCID.
- No current anorexia or bulimia diagnosis (past 3months). Rationale: The investigators have concerns about the safety of physical activity for individuals with these disorders.
- No current psychotic symptoms (in past month), no history of schizophrenia and other psychotic disorders
- No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet criteria for a moderate or severe substance use disorder in the past 6 months.
- Depression is not very severe, i.e., QIDS score is < 20. At high levels of depression severity, participants are at risk for psychiatric hospitalization, suicidality, and other problems that would interfere with physical activity. The investigators will provide referrals if needed for these individuals.
- No suicidality requiring immediate treatment. The investigators will take necessary steps to ensure these individuals get appropriate assessment.
- Not pregnant or planning on becoming pregnant in the next year. Although exercise is recommended for most pregnant women, risks and benefits of exercise, and type of exercise recommended, may change when one is pregnant.
- Able to consent and complete study assessments. Participants must be able to understand English well enough to consent and complete assessments. Further, if participants are aged 60 or older, or if there is any concern about their cognitive capacity, participants will undergo a brief cognitive functioning screener, the Montreal Cognitive Assessment (MoCA). Participants must achieve a score within 1 SD of the mean for their age and education level to participate in the study (32).
- Aged 18-65.
- Able to make one of the 2 available exercise class times.
- Receiving medication treatment for bipolar disorder
- Body weight does not exceed 375 lbs. Most of our exercise machines do not accommodate individuals with a higher body weight. As a result, if the investigators recruit these individuals, they may not have the machines available to allow them to exercise.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：BA + 彼女 + 彼
運動の簡単なアドバイス + 監視付き & 自宅での運動 + 健康教育
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The BA intervention will be conducted in one 45-minute session in the week after randomization.
Participants will meet with the exercise physiologist and have a discussion about: public health guidelines for physical activity (i.e., gradual increase to 150 minutes of MVPA per week), physical and mental health benefits of physical activity, components of typical workout (including warm-up, aerobic zone, cool-down, and knowing when to stop), and how to determine exercise intensity (e.g., rate of perceived exertion (RPE) scale, obtaining radial and carotid pulse), the benefits of maintaining a structured schedule of consistent daily routines and a regular sleep schedule to manage depression and mania.
Participants assigned to SHE will attend individual aerobic exercise (AE) sessions supervised by an exercise physiologist once a week at the Butler Hospital Fitness Facility.
Exercise at the Butler Hospital Fitness Facility will last ~1 hour, and includes: review of self-monitoring logs (5 minutes), warm-up (5-10 mins), AE (beginning at 20 minutes per session with weekly gradual increases based on heart rate monitoring by the exercise physiologist, with the target being the moderate-intensity range of 64-76% of age-predicted maximal heart rate (28) for each participant), cool-down (5-10 minutes), stretching (5 minutes), and exercise plans for the next week (5 minutes).
Participants will choose from several types of exercise equipment, including treadmills, recumbent bicycles, and elliptical machines.
Health education sessions will serve as a contact control for CBEX.
Participants will attend individual sessions.
After the initial BA session (week 1), sessions will include HE information such as: nutrition; caffeine; colds, germs, and flu; preventing cancer; diabetes; heart health; sleep; complementary and alternative medicine; caffeine; and being a smart patient
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実験的：BA + 彼女 + CBEX
運動に関する簡単なアドバイス + 監視付きの自宅での運動 + 運動の増加と維持に焦点を当てた認知行動セッション
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The BA intervention will be conducted in one 45-minute session in the week after randomization.
Participants will meet with the exercise physiologist and have a discussion about: public health guidelines for physical activity (i.e., gradual increase to 150 minutes of MVPA per week), physical and mental health benefits of physical activity, components of typical workout (including warm-up, aerobic zone, cool-down, and knowing when to stop), and how to determine exercise intensity (e.g., rate of perceived exertion (RPE) scale, obtaining radial and carotid pulse), the benefits of maintaining a structured schedule of consistent daily routines and a regular sleep schedule to manage depression and mania.
Participants assigned to SHE will attend individual aerobic exercise (AE) sessions supervised by an exercise physiologist once a week at the Butler Hospital Fitness Facility.
Exercise at the Butler Hospital Fitness Facility will last ~1 hour, and includes: review of self-monitoring logs (5 minutes), warm-up (5-10 mins), AE (beginning at 20 minutes per session with weekly gradual increases based on heart rate monitoring by the exercise physiologist, with the target being the moderate-intensity range of 64-76% of age-predicted maximal heart rate (28) for each participant), cool-down (5-10 minutes), stretching (5 minutes), and exercise plans for the next week (5 minutes).
Participants will choose from several types of exercise equipment, including treadmills, recumbent bicycles, and elliptical machines.
Participants in the CBEX condition will participate in a 30-minute individual counseling session focused on teaching cognitive-behavioral skills to help with increasing motivation and adherence to exercise.
CBEX targets: 1) anhedonia, amotivation, increased fatigue, and other individual-level barriers associated with major depression; 2) other individual-level determinants of behavior change described by the Health Belief Model and self-determination theory; and 3) social environment and physical environment factors associated with exercise (through social skills coaching and problem-solving training).
Each session will begin with a review of personal barriers and facilitators to exercise, and the therapist will assist the patient with using skills learned in CBEX to manage barriers.
Sessions will emphasize making personal choices consistent with goals and values, and participants will have menus of options whenever possible.
Participants receive a workbook to use for this intervention
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他の：BA only
Brief advice to exercise.
This serves as a control condition.
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The BA intervention will be conducted in one 45-minute session in the week after randomization.
Participants will meet with the exercise physiologist and have a discussion about: public health guidelines for physical activity (i.e., gradual increase to 150 minutes of MVPA per week), physical and mental health benefits of physical activity, components of typical workout (including warm-up, aerobic zone, cool-down, and knowing when to stop), and how to determine exercise intensity (e.g., rate of perceived exertion (RPE) scale, obtaining radial and carotid pulse), the benefits of maintaining a structured schedule of consistent daily routines and a regular sleep schedule to manage depression and mania.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To measure the acceptability, feasibility, and safety of the program via scores on the Client Satisfaction Questionnaire (CSQ)
時間枠：at 3 months
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CSQ scores range from 8 to 32.
Higher scores indicate a greater degree of satisfaction.
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at 3 months
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To measure the acceptability, feasibility, and safety of the program via adherence to weekly SHE and HE or CBEX sessions
時間枠：from baseline to 3 months
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Participants attended between 0 and 11 SHE and HE or CBEX sessions.
Higher scores indicate higher adherence.
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from baseline to 3 months
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To measure the acceptability, feasibility, and safety of the program via completion of 3 month and 6 month interviews
時間枠：at 3 months, 6 months
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at 3 months, 6 months
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To compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase via International Physical Activity Questionnaire (IPAQ)
時間枠：from baseline to 3 months
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The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week.
Scores range from 0 to no maximum number.
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from baseline to 3 months
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To compare preliminary long-term effect of the 3 arms on minutes of MVPA at 6-month follow-up via International Physical Activity Questionnaire (IPAQ)
時間枠：from 3 months to 6 months
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The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week.
Scores range from 0 to no maximum number.
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from 3 months to 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月18日
一次修了 (実際)
2020年4月2日
研究の完了 (実際)
2020年4月2日
試験登録日
最初に提出
2026年7月30日
QC基準を満たした最初の提出物
2026年8月12日
最初の投稿 (実際)
2026年8月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。