Diet and Exercise for Schizophrenia

Recruiting in Palo Alto (17 mi)

Overseen by Jason R. Tregellas, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Must be taking: Olanzapine, Risperidone, Clozapine, Haloperidol

Disqualifiers: Pregnancy, Substance abuse, Endocrine/metabolic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it includes participants who are either on specific medications (olanzapine, risperidone, clozapine, or haloperidol) or not on any neuroleptic medications, so it seems you can continue your current treatment if it fits these criteria.

What data supports the effectiveness of the treatment Diet, Exercise, Physical Activity, Workout, Fitness Training for schizophrenia?

Research shows that physical exercise can improve the quality of life and functional capacity in people with schizophrenia. Additionally, a study found that a combination of behavior intervention, nutritional information, and physical exercise helped reduce body weight and maintain this loss in people with schizophrenia. ^{1 2 3 4 5}

Is diet and exercise safe for people with schizophrenia?

Research shows that people with schizophrenia can safely participate in various forms of exercise, including aerobic and resistance training, with positive effects on their health and functioning. These activities have been studied and found to be safe, helping to improve physical fitness and reduce some symptoms without significant safety concerns. ^{2 6 7 8 9}

How does the 'Diet and Exercise for Schizophrenia' treatment differ from other treatments for this condition?

This treatment is unique because it focuses on lifestyle changes, specifically diet and exercise, to improve the quality of life and reduce metabolic risks in schizophrenia patients, rather than relying solely on medication. It addresses both physical health and mental well-being, which is not typically the primary focus of standard schizophrenia treatments. ^{1 2 6 10 11}

Eligibility Criteria

This trial is for adults aged 21-70 with schizophrenia or schizoaffective disorder, who are either on olanzapine, risperidone, clozapine, haloperidol or not on neuroleptic medications. They should have had a stable weight in the past 6 months. Pregnant individuals, those with substance abuse issues or significant metabolic diseases, and anyone unable to undergo MRI due to claustrophobia or metal implants cannot participate.

Inclusion Criteria

I have been diagnosed with schizophrenia or schizoaffective disorder.

I am taking olanzapine, risperidone, clozapine, or haloperidol, or I am not on any neuroleptic medications.

I am between 21 and 70 years old.

Exclusion Criteria

MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Pregnancy

Substance abuse

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Intervention

Participants undergo a moderate exercise intervention to evaluate changes in brain responses and food preferences

10 weeks

Diet Intervention

Participants follow a diet intervention to evaluate changes in brain responses and food preferences

10 weeks

Follow-up

Participants are monitored for changes in neuronal response and fasting hormone levels after interventions

4 weeks

Treatment Details

Interventions

• Diet (Behavioral Intervention)
• Exercise (Behavioral Intervention)

Trial Overview The study examines how diet and exercise affect brain response to food images and preferences in people taking common schizophrenia drugs that may cause weight gain. Participants will be asked about their eating habits and symptoms and might do an exercise or diet program to see if it changes how their brain reacts to food.

Participant Groups

Group I: Exercise intervention Experimental Treatment 1 Intervention

10 weeks of a moderate exercise intervention

Group II: Diet intervention Active Control 1 Intervention

10 weeks of a diet intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Colorado Anschutz Medical Campus Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

National Center for Advancing Translational Sciences (NCATS) Collaborator

National Institute of Mental Health (NIMH) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Neurobiological effects of physical exercise in schizophrenia: a systematic review. [2018] The aim of the present systematic review was to provide a summary of neurobiological effects of physical exercise for people with schizophrenia.

2. England pubmed.ncbi.nlm.nih.gov

Effects of exercise training with traditional dancing on functional capacity and quality of life in patients with schizophrenia: a randomized controlled study. [2022] To examine the effects of an eight-month exercise training programme with Greek traditional dancing on functional capacity and quality of life in patients with schizophrenia.

3. China pubmed.ncbi.nlm.nih.gov

[Levels and evaluations of physical activity using 5-A counseling model in patients with stable schizophrenia]. [2019] To explore the levels and evaluations of physical activity (PA) using 5-A counseling model in patients with stable schizophrenia.

4. Poland pubmed.ncbi.nlm.nih.gov

Physical activity as a therapeutic method for non-pharmacological treatment of schizophrenia: A systematic literature review. [2023] The purpose of this systematic review was to classify, compare and characterize selected types of physical activity having a positive impact on the course of the treatment of schizophrenia (including its long-term effects).

5. United States pubmed.ncbi.nlm.nih.gov

Multi-modal weight control intervention for people with persistent mental disorders. [2008] Obesity, a major problem worldwide, is more prevalent among people with schizophrenia. This study examined the effect of behavior intervention, nutritional information and physical exercise on the body mass index (BMI) and weight of people who were hospitalized with persistent DSM-IV schizophrenia and schizoaffective disorders. Fifty nine inpatients with a BMI greater than 25 participated, (28 intervention group; 31 control group). Significant reductions in BMI and weight were observed in the intervention group after 3 months and were maintained 1-year post study [F(1,52) = 6.1, p = .017) and F(1,52) = 3.7, P = .006, respectively]. If provided with adequate information and an appropriate framework, people with persistent schizophrenia can significantly reduce BMI and weight and maintain the loss.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review. [2019] Individuals with major psychotic disorders such as schizophrenia are at increased risk for developing metabolic syndrome due to lifestyle- and treatment-related factors. Numerous interventions have been tested in inpatient and outpatient mental health settings to decrease risk factors. Diet and exercise represent the mainstay of weight loss treatment. With this background the review aimed to evaluate the effects of psychoeducation, diet and physical activity interventions on reduction of metabolic syndrome risk factors such as BMI, Body weight, biochemical profiles in schizophrenia.

7. Ireland pubmed.ncbi.nlm.nih.gov

The effect of mind-body and aerobic exercise on negative symptoms in schizophrenia: A meta-analysis. [2020] This meta-analysis aims to evaluate the effects of different types of physical exercise (PE) on negative symptoms in schizophrenia patients. Mind-body exercise (MBE), aerobic exercise (AE) and resistance training (RT) will be investigated.

8. England pubmed.ncbi.nlm.nih.gov

Resistance training in patients with schizophrenia: Concept and proof of principle trial. [2021] Resistance training has been shown to contribute to the prevention and management of cardiovascular diseases, which is why it can help reducing morbidity and mortality in schizophrenia patients. Moreover, positive effects on different schizophrenia symptom domains have been proposed. However, a specific resistance training tailored to the needs of schizophrenia patients and its evaluation is still lacking. The objective in this proof of principle trial was to evaluate the feasibility and efficacy of a newly developed 12-week resistance program according to current recommendations of the WHO and the American College of Sports Medicine. We employed a single blind, parallel assignment clinical trial design with participants randomized to attend either a resistance training including three 50min units per week or a balance and tone program as control condition. The primary outcome was the impact on health-related difficulties assessed with the World Health Organization Disability Assessment Schedule (WHO-DAS). Secondary outcome parameters included the level of functioning, schizophrenia symptoms, selected cognitive parameters as well as risk factors for cardiovascular diseases. In our proof of principle trial, we could not find significant time or group effects of resistance training on the WHO-DAS. However, we could observe significant positive effects on the level of functioning assessed with the Global Assessment of Functioning Scale (GAF) over the course of time, which were more pronounced in the intervention group. Our findings indicated that patients with schizophrenia could safely participate in resistance training with relevant improvements in their level of functioning. Well-powered replication trials are needed to provide more efficacy data.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Aerobic, Resistance, and Combined Exercise Training on Psychiatric Symptom Severity and Related Health Measures in Adults Living With Schizophrenia: A Systematic Review and Meta-Analysis. [2022] Previous research has demonstrated the efficacy, effectiveness, and safety of exercise training in persons living with schizophrenia. However, the optimal exercise training program remains unclear. The aim of this paper was to conduct a systematic review and meta-analysis of the effects of aerobic, resistance, and combined aerobic and resistance training on health-related physical fitness and positive and negative symptoms in persons living with schizophrenia. Six electronic databases were searched systematically from their inception to December 2020 [MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, SPORTDiscus, and Cumulative Index to Nursing and Allied Health Literature (CINAHL)] to identify literature examining the effects of exercise training on psychiatric symptoms and health-related physical fitness indicators in persons living with schizophrenia. A total of 22 studies (n = 913) were included in this review, and 12 studies (n = 554) included within the meta-analysis reported the effects of exercise training (aerobic, resistance, and combined aerobic and resistance) in persons living with schizophrenia. Aerobic training had a significant decrease on Positive and Negative Syndrome Scale (PANSS) negative scores (ES -2.28, 95% CI -3.57 to -1.00; p = 0.0005) and PANSS general scores (ES -2.51, 95% CI -3.47 to -1.55; p < 0.00001). Resistance training did not lead to significant effects on PANSS total scores. Combined aerobic and resistance training did not lead to significant changes in body mass index, PANSS positive scores, or PANSS total scores. However, grouping together the results from all exercise training modalities (including aerobic training, resistance training, and combined aerobic and resistance training) revealed significant effects on body mass index (ES 1.86, 95% CI 0.84 to 2.88; p = 0.0003), maximal/peak oxygen consumption (ES 2.54, 95% CI 1.47 to 3.62; p = < 0.00001), body weight (ES 6.58, 95% CI 2.94 to 10.22; p = 0.0004), PANSS negative scores (ES -1.90, 95% CI -2.70 to -1.10; p < 0.00001), and Scale for the Assessment of Negative Symptoms (SANS) total (ES -14.90, 95% CI -22.07 to -7.74; p < 0.0001). Collectively, these findings support the importance of exercise participation (aerobic and resistance training) in persons living with schizophrenia.

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of physical activity and nutrient supplementation on symptoms and well-being of schizophrenia patients: An umbrella review. [2023] Physical activity and nutrient supplementation have been acknowledged to have moderate effects on symptoms and treatment compliance of patients suffering from mental disorders. However, there is still a lack of consensus on whether these interventions are effective on schizophrenia clinical and quality of life outcomes. Our objective was to provide a comprehensive review of systematic reviews that addressed the effects of physical activity and nutrient supplementation on treatment compliance, symptoms and improving the well-being of patients with schizophrenia.

11. United States pubmed.ncbi.nlm.nih.gov

Making evidence-based lifestyle modification programs available in community mental health centers: why so slow? [2018] Lifestyle modification programs to promote healthy diet and physical fitness should be an integral component of the treatment provided in community mental health centers. Over 50% of adults with serious mental illness are obese. Persons with schizophrenia consume more calories and saturated fats, on average, than the general population, while fewer than 20% engage in regular physical activity.