Project MOVE Bipolar

NCT07767032 | Completed DMC

• 2 other identifiers: 1508-003NCT02691845 - Parent grant
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.brief advice (BA) to exercise (control condition);
2. 2.BA + supervised \& home-based exercise (SHE) + health education (HE) contact control; and
3. 3.BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).

Conditions

Bipolar Disorder (BD)

Keywords

Physical Activity; Intervention; Bipolar Disorder

Outcome Measures

Primary Outcomes (5)

• To measure the acceptability, feasibility, and safety of the program via scores on the Client Satisfaction Questionnaire (CSQ)

  CSQ scores range from 8 to 32. Higher scores indicate a greater degree of satisfaction.

  at 3 months

• To measure the acceptability, feasibility, and safety of the program via adherence to weekly SHE and HE or CBEX sessions

  Participants attended between 0 and 11 SHE and HE or CBEX sessions. Higher scores indicate higher adherence.

  from baseline to 3 months

• To measure the acceptability, feasibility, and safety of the program via completion of 3 month and 6 month interviews

  at 3 months, 6 months

• 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)

  The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week. Scores range from 0 to no maximum number.

  from baseline to 3 months

• 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)

  The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week. Scores range from 0 to no maximum number.

  from 3 months to 6 months

Study Arms (3)

BA only

OTHER

Brief advice to exercise. This serves as a control condition.

Behavioral: BA

BA + SHE + HE

ACTIVE COMPARATOR

Brief advice to exercise + supervised \& home-based exercise + health education

Behavioral: BA; Behavioral: SHE; Behavioral: HE

BA + SHE + CBEX

EXPERIMENTAL

Brief advice to exercise + supervised \& home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise

Behavioral: BA; Behavioral: SHE; Behavioral: CBEX

Interventions

BA BEHAVIORAL

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.

BA + SHE + CBEX; BA + SHE + HE; BA only

SHE BEHAVIORAL

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.

BA + SHE + CBEX; BA + SHE + HE

HE BEHAVIORAL

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

BA + SHE + HE

CBEX BEHAVIORAL

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

BA + SHE + CBEX

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 17, 2026
• Study Start: January 18, 2018
• Primary Completion: April 2, 2020
• Study Completion: April 2, 2020
• Last Updated: August 17, 2026

Record last verified: 2026-06

Locations

US (1)