Project MOVE Bipolar
keskiviikko 12. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
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).
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
22
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Rhode Island
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Providence, Rhode Island, Yhdysvallat, 02906
- Butler Hospital
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: BA + SHE + HE
Lyhyet neuvot harjoitteluun + ohjattu & kotiliikunta + terveyskasvatus
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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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Kokeellinen: BA + SHE + CBEX
Lyhyet neuvot harjoitteluun + ohjattu ja kotiharjoitus + kognitiivis-käyttäytymistunnit, jotka keskittyvät liikunnan lisäämiseen ja ylläpitämiseen
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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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Muut: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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To measure the acceptability, feasibility, and safety of the program via scores on the Client Satisfaction Questionnaire (CSQ)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
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Torstai 30. heinäkuuta 2026
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Ensimmäinen Lähetetty (Todellinen)
Maanantai 17. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 17. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 1508-003
- NCT02691845 - Parent grant (Muu tunniste: Clinicaltrials.gov ID)
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