Telehealth Aerobic Exercise & Cognitive Training for Schizophrenia

Overseen By Keith H. Nuechterlein, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Neurological disorder, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different activities can improve brain function in people with schizophrenia. All participants receive cognitive training to enhance thinking and memory skills. Some will also engage in aerobic exercise, such as walking or cycling, to determine if it boosts results. Online tools facilitate participation and maintain motivation. The trial seeks individuals who have experienced their first episode of psychosis—a mental health condition affecting thoughts, feelings, and perception of reality—within the past three years and live near UCLA. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cognitive training is safe and feasible for people with schizophrenia. One study found that a six-month outpatient cognitive training program was safe, with participants attending sessions regularly and no major safety issues reported.

Similarly, research on aerobic exercise has shown positive outcomes for those with schizophrenia. Exercise programs, including activities like walking and strength training, are safe and can help reduce symptoms of schizophrenia. Participants in these programs often experience improved thinking skills and fewer negative symptoms.

Both cognitive training and exercise are well-tolerated by individuals with schizophrenia. No significant negative effects have been reported, making these treatments promising options for improving mental health in this group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Aerobic Exercise and Cognitive Training approach for schizophrenia because it offers a unique combination of physical and mental health interventions. Unlike traditional treatments that rely heavily on medication and therapy, this method integrates a structured aerobic exercise program with cognitive training and online social support, all delivered through telehealth. This combination not only targets physical health and cognitive function but also provides a flexible and accessible way for participants to engage in their treatment from home. By addressing multiple aspects of health and well-being, this approach has the potential to enhance overall quality of life for individuals with schizophrenia.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that cognitive training, which participants in this trial may receive, helps people with schizophrenia improve memory, attention, and problem-solving skills. Another treatment option in this trial is aerobic exercise, which studies have found beneficial for lessening symptoms of schizophrenia and enhancing quality of life. Exercise supports brain health by promoting the brain's ability to change and adapt. Together, these treatments may offer a comprehensive approach to improving both mental and physical health in people with schizophrenia. ^{1 2 6 7 8}

Who Is on the Research Team?

Keith H Nuechterlein, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-45 who have experienced their first psychotic episode within the last two years and are diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder. Participants should be fluent in English, live near UCLA's Aftercare Research Program, and be able to commute there.

Inclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder.

I am fluent in English and understand the culture well.

First episode of a psychotic illness that began within the past two years

Exclusion Criteria

Premorbid IQ less than 70

Evidence of moderate or severe substance use disorder within the six months prior to the first episode or evidence of a substance-induced psychosis

I have a known neurological disorder or have had a significant head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive training and are randomly assigned to either the aerobic exercise and strength training condition or the Healthy Living Group condition. The interventions are delivered via videoconferencing.

12 months

Weekly sessions via videoconferencing

Follow-up

Participants are monitored for changes in cognitive performance and engagement in exercise sessions.

3 months

Extension

Participants continue with reduced frequency of group sessions to maintain exercise and cognitive training benefits.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Program
• Chorus Participatory Text Messaging Program
• Cognitive training
• Healthy Living Group (HLG)
• Moderated Online Social Therapy (MOST)

Trial Overview The study tests if cognitive training combined with either aerobic exercise or a Healthy Living Group improves cognition in patients after a first schizophrenia episode. It measures engagement levels and brain changes indicating neuroplasticity through serum BDNF levels. The program is delivered via videoconferencing to test its wider applicability.

How Is the Trial Designed?

Group I: Randomization to Combined Cognitive Training and Exercise (CT&E) Experimental Treatment 4 Interventions

The primary interventions for this arm of the protocol are Cognitive Training and Exercise sessions. The Cognitive Training will be conducted in a group format using Zoom videoconferencing, with participants logging into their individual Posit Science cognitive training accounts. The Aerobic Exercise Program will consist of a physical exercise intervention of 150 minutes/week of moderate aerobic activity, over 4 days, including two group sessions (45 min duration) and two individual sessions (30 min duration in the heart rate zone), for 6 months. After the first 6 months, the group sessions will be once a week with the continuing goal of 150 minutes/week of moderate exercise.

Group II: Cognitive Training and Healthy Living Group (CT&HLG) Active Control 3 Interventions

The primary interventions for this arm of the protocol are Cognitive Training and the Healthy Living Group. The Cognitive Training will be conducted in a group format using Zoom videoconferencing, with participants logging into their individual Posit Science cognitive training accounts. The participants in this arm will also participate in a Healthy Living Group, which is a didactic, educational and interactive group that is designed to offer very useful information and discussion of topics that are relevant to a healthy lifestyle. It includes manualized modules devoted to wellness, nutrition, insight, recovery, independent living, social skills, and hobbies. It meets 2 times/week for 6 months and then once a week for the next 6 months.

Aerobic Exercise Program is already approved in European Union, United States for the following indications:

Approved in European Union as Aerobic Exercise for:

• Improvement in cognitive functioning in schizophrenia
• Reduction in psychiatric symptoms of schizophrenia
• Enhancement of global functioning and quality of life

Approved in United States as Aerobic Exercise for:

• Improvement in cognitive functioning in schizophrenia
• Reduction in psychiatric symptoms of schizophrenia
• Enhancement of global functioning and quality of life

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A 6-month program combining cognitive training and aerobic exercise (CT&E) significantly improved cognitive function in 47 first-episode schizophrenia patients compared to cognitive training alone, especially in the first 3 months.

The study found that the amount of aerobic exercise completed was strongly linked to improvements in both cognitive abilities and work/school functioning, suggesting that exercise enhances the effectiveness of cognitive training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise enhances cognitive training effects in first-episode schizophrenia: randomized clinical trial demonstrates cognitive and functional gains. Nuechterlein, KH., McEwen, SC., Ventura, J., et al.[2023]

Aerobic exercise (AE) has been shown to potentially increase hippocampal volume and cortical thickness in individuals with schizophrenia, which may help counteract neurocognitive deficits associated with the disorder.

AE significantly boosts levels of brain-derived neurotrophic factor (BDNF), which is linked to neurogenesis and cognitive improvements, leading to enhanced overall cognition, including better processing speed, working memory, and visual learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise in People with Schizophrenia: Neural and Neurocognitive Benefits. Vakhrusheva, J., Marino, B., Stroup, TS., et al.[2020]

A pilot study involving 16 patients with recent onset schizophrenia showed that combining cognitive training with aerobic exercise (CT&E) led to significant improvements in cognitive function compared to cognitive training alone, particularly in overall cognitive scores.

The CT&E group also demonstrated better functional outcomes, including enhanced independent living skills and improvements in physical health measures like muscular endurance and cardiovascular fitness, suggesting that this combined approach may be beneficial in the early treatment of schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Cognitive Training Through Aerobic Exercise After a First Schizophrenia Episode: Theoretical Conception and Pilot Study. Nuechterlein, KH., Ventura, J., McEwen, SC., et al.[2020]

Patients with schizophrenia have a significantly higher prevalence of metabolic syndrome and cardiovascular diseases, leading to a reduced life expectancy of up to 20 years compared to the general population.

Regular physical activity, particularly high-intensity interval training, can improve metabolic syndrome parameters, cognitive deficits, and overall quality of life in schizophrenia patients, although more controlled trials are needed to establish effective exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Exercise on Metabolic Syndrome, Cardiorespiratory Fitness, and Symptoms in Schizophrenia Include Decreased Mortality. Schmitt, A., Maurus, I., Rossner, MJ., et al.[2020]

In a pilot study involving 32 patients with schizophrenia, those who participated in combined individual and group aerobic exercises showed significant improvements in cognitive function, motivation, psychiatric symptoms, and interpersonal relations over 12 weeks.

The results suggest that integrating aerobic exercises into treatment can enhance cognitive and social outcomes for individuals with schizophrenia, indicating a potential new approach to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise and cognitive functioning in schizophrenia: A pilot randomized controlled trial. Shimada, T., Ito, S., Makabe, A., et al.[2020]

This study aims to evaluate the effects of a 12-week aerobic high-intensity interval training program on neurocognitive function and mental symptoms in outpatients with schizophrenia, comparing it to computer gaming skills training.

The trial is designed as a randomized controlled trial, which will help determine if physical activity can improve cognitive abilities and reduce symptoms in individuals with schizophrenia, alongside their usual treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial. Engh, JA., Andersen, E., Holmen, TL., et al.[2018]

Aerobic exercise (AE) significantly improved global cognition in patients with schizophrenia after 6 months, based on a review of 23 studies with 1014 participants.

Specifically, AE enhanced verbal learning, memory, reasoning, and problem-solving skills, while effects on other cognitive domains like attention and social cognition were not significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of aerobic exercise on cognitive function in patients with schizophrenia during daily care: A meta-analysis. Xu, Y., Cai, Z., Fang, C., et al.[2022]

High-intensity interval training (HIT) significantly improved peak oxygen uptake (VO2peak) by 12% and net mechanical efficiency of walking by 12% in patients with schizophrenia over 8 weeks, indicating enhanced physical capacity.

Despite these improvements in physical fitness, psychiatric symptoms did not show any significant change in either the HIT or control group, suggesting that while HIT benefits physical health, it may not directly impact mental health symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high aerobic intensity training in patients with schizophrenia: a controlled trial. Heggelund, J., Nilsberg, GE., Hoff, J., et al.[2021]

In a study of 96 patients with schizophrenia, combining computerised cognitive remediation therapy (CCRT) with aerobic exercise (CAE) significantly improved cognitive functions like processing speed and cognitive flexibility compared to control and aerobic exercise alone after 8 weeks.

Both CAE and aerobic exercise groups showed increased serum BDNF levels, a protein linked to brain health, but only the CAE group demonstrated improvements in negative symptoms of schizophrenia, highlighting the potential benefits of this combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CCRT and aerobic exercise: a randomised controlled study of processing speed, cognitive flexibility, and serum BDNF expression in schizophrenia. Dai, Y., Ding, H., Lu, X., et al.[2022]

A 12-week aerobic exercise program significantly improved cardiorespiratory fitness in 54 veterans with schizophrenia, demonstrating its efficacy in enhancing physical health (p<.0001).

The aerobic exercise also showed trend-level improvements in social functioning, suggesting a potential link between increased fitness and better social outcomes, with a correlation of r=.42 (p<.01).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise on cardiorespiratory fitness and social functioning in veterans 40 to 65 years old with schizophrenia. Kern, RS., Reddy, LF., Cohen, AN., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8860832/

Effects of Aerobic, Resistance, and Combined Exercise ... Previous research has demonstrated the efficacy, effectiveness, and safety of exercise training in persons living with schizophrenia.

2. nature.com nature.com/articles/s41537-023-00426-0

Efficacy and feasibility of aerobic exercise interventions as ... Aerobic exercise interventions, as adjunctive therapy, are an effective measure for reducing PANSS scores in patients with schizophrenia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6386427/

Exercise as a Treatment for Schizophrenia: A Review - PMC Exercise therapy has been shown to improve positive and negative symptoms, quality of life, cognition, and hippocampal plasticity.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1755296616300965

Combined aerobic and resistance exercise interventions ... Combined exercise is effective at decreasing symptoms of schizophrenia. Combined training increases muscular strength in people with schizophrenia.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2215001319300010

The synergistic benefits of physical and cognitive exercise ... Emerging research highlights the potential cognitive benefits of physical exercise (PE) programs for schizophrenia (SCZ). The few recent efficacy studies ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5067077/

Aerobic Exercise in People with Schizophrenia Individuals with schizophrenia in the exercise group demonstrated 15.1 % improvement in overall cognitive functioning, while performance in the treatment as ...

7. nature.com nature.com/articles/s41598-024-57081-3

a systematic review with network meta-analysis Moreover, some studies indicate that aerobic exercise and mind–body exercises significantly impact the negative symptoms of schizophrenia26,27.

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.807140/full

The efficacy and safety of exercise and physical activity on ... Conclusion: Aerobic activity as an exercise modality in a hospital setting can be effective in decreasing negative and general psychosis symptom ...