SchizophreniaCREWNCT06044038
Exercise Intervention for People With Schizophrenia (CREW)
A study testing Physical activity and Cognitive rehabilitation program in people with Schizophrenia, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The study aims to investigate the feasibility and adherence of long-term, moderate-intensity different types of physical activity programs for individuals with schizophrenia. Secondary outcomes are related to the control of non-communicable disease risk factors and the improvement of exercise capacity, body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Physical activity and Cognitive rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with schizophrenia for at least 1 year
- On antipsychotic medications with the same therapeutic regimen for at least 3 months before enrolment
- Free of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with physical activity sessions
Who cannot join
- Recent modification of the therapeutic regimen
- Presence of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with physical activity sessions
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Center for Exercise Science and Sport
Ferrara, 44123
Simona Mandini, PhD, +39 0535455963, simona.mandini@unife.it
Andrea Raisi, MSc, +39 0535455963, andrea.raisi@unife.it
About this study
Official title: Enhancing Functional Capacity and Body Composition of Individuals With Schizophrenia Through a Physical Exercise Intervention
The study aims to investigate the feasibility and adherence of long-term, moderate-intensity different types of physical activity programs for individuals with schizophrenia. Secondary outcomes are related to the control of non-communicable disease risk factors and the improvement of exercise capacity, body composition and cognitive function.
Read the detailed description
Schizophrenia is a common public health issue that generates a social and economic burden. Individuals affected by schizophrenia experience severe and chronic levels of disability that derive from acute psychotic symptoms, as well as cognitive impairments for which available treatments offer only limited benefits. Moreover, their life expectancy is lower, and they have a higher prevalence of heart diseases risk factors such as obesity, dyslipidemia, smoking, hypertension, diabetes and physical inactivity than the general population. The World Health Organization and the European Mental Health Action Plan 2013-2020 acknowledge the role of physical activity in mental health and encourage the inclusion of lifestyle changes in education and treatment programs for people with mental illness, delivered in primary and secondary healthcare settings. The benefits of regular physical activity are well-recognized and are inversely associated with mortality risk and the incidence of many chronic diseases. Moreover, it plays a critical role in preserving and even improving cognitive function throughout the lifespan. However, people with schizophrenia tend to be less engaged in physical activity programs than the general population and report a range of barriers such as pain, side effects of medications and negative symptoms.
The purpose of this trial is to evaluate the efficacy of an exercise-based intervention program among people with schizophrenia.
All individuals with schizophrenia were screened for eligibility. After verifying inclusion and exclusion criteria and after eligibility is confirmed, written informed consent must be obtained prior to randomization. Baseline patient characteristics (i.e., demographics, medical history, laboratory test results) have been collected and recorded for further assessment. Randomization was performed during the inclusion visit (T1). Randomization will be performed centrally using an internet-based system. The identification number (ID) and the treatment allocation will be assigned by the randomization system. Patients were randomized to physical activity group or usual care by a 2:1 allocation. After the randomization, all participants underwent the same battery of tests and questionnaires according to the study protocol.
All patients were involved in the usual care cognitive program. It was held in weekly 90-minute sessions in a Psychiatric Rehabilitation Center of the Healthcare District of Ferrara. Specialized psychiatric therapists conduct this program with groups of 5-10 participants, based on a Cognitive Remediation model. Each session consists of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks. Tasks include games and exercises (e.g., sudoku, crosswords), as well as discussions aimed at improving short- and long-term memory (i.e., repeating sequences of words and numbers), executive functions, and social cognition, with progressive adaptation of task difficulty. The total number of sessions is 50 for a duration of 12 months. In addition, the intervention arm was involved in a supervised exercise-based program. They could voluntarily participate in a variety of activities such as walking or Nordic walking groups, gentle gymnastics, soccer, swimming, and volleyball. Each activity was scheduled twice a week.
- Conditions
- Schizophrenia
- Being tested
- Physical activity, Cognitive rehabilitation program
- Keywords
- Schizophrenia, Physical activity, Mental disorder
- Medical subject headings
- Schizophrenia, Motor Activity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Bi-weekly supervised physical activity intervention
Cognitive rehabilitation programBehavioural
weekly 90-minute session consisting of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | Participation in supervised activities such as walking or Nordic walking groups, gentle gymnastics, soccer, swimming, and volleyball. Each activity was scheduled twice a week. Receives: Behavioral: Physical activity; Behavioral: Cognitive rehabilitation program |
| Usual care group | Other | Participants in the control group attended weekly 90-minute cognitive rehabilitation sessions according to the usual care procedure in this type of population. Receives: Behavioral: Cognitive rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Uptake (VO2peak)
Measurement of cardiorespiratory fitness, reported as ml/kg/min and estimated through a moderate and perceptually regulated 1km treadmill walk test (1k-TWT) or through related short-forms (500m or 200m)
Measured: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Body Mass Index (kg/m²)
Derived from the measurement of weight in kilograms and height in meters
Measured: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Waist circumference (cm)
Measurement of waist circumference
Measured: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Screen for Cognitive Impairment in Psychiatry (SCIP)
Values range from 0 to >100, higher scores mean a better outcome
Measured: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Frontal Assessment Battery (FAB)
Values range from 0 to18, higher scores mean a better outcome
Measured: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Secondary outcomes (1)
Adherence
Number of physical activity sessions attended by the participants and the number of drop-outs
Measured: From date of enrollment until the date of the end of follow-up (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Dec 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandini Simona, Università degli Studi di Ferrara
- Investigators
- Gianni Mazzoni, Professor, Study director, Università degli Studi di FerraraSimona Mandini, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044038
- Sponsor's protocol ID
- CSB-23-02
- Acronym
- CREW
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mandini S, Morelli M, Belvederi Murri M, Grassi L, Masotti S, Simani L, Zerbini V, Raisi A, Piva T, Grazzi G, Mazzoni G. Adherence to a guided walking program with amelioration of cognitive functions in subjects with schizophrenia even during COVID-19 pandemic. BMC Sports Sci Med Rehabil. 2022 Mar 25;14(1):48. doi: 10.1186/s13102-022-00440-2.
PubMed 35337370
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Functional Capacity and Body Composition of Individuals With Schizophrenia Through a Physical Exercise Intervention
- ClinicalTrials.gov ID
- NCT06044038
- Acronym / sponsor ID
- CREW / CSB-23-02
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Physical activity, Mental disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the feasibility and adherence of long-term, moderate-intensity different types of physical activity programs for individuals with schizophrenia. Secondary outcomes are related to the control of non-communicable disease risk factors and the improvement of exercise capacity, body composition and cognitive function.
Detailed description
Schizophrenia is a common public health issue that generates a social and economic burden. Individuals affected by schizophrenia experience severe and chronic levels of disability that derive from acute psychotic symptoms, as well as cognitive impairments for which available treatments offer only limited benefits. Moreover, their life expectancy is lower, and they have a higher prevalence of heart diseases risk factors such as obesity, dyslipidemia, smoking, hypertension, diabetes and physical inactivity than the general population. The World Health Organization and the European Mental Health Action Plan 2013-2020 acknowledge the role of physical activity in mental health and encourage the inclusion of lifestyle changes in education and treatment programs for people with mental illness, delivered in primary and secondary healthcare settings. The benefits of regular physical activity are well-recognized and are inversely associated with mortality risk and the incidence of many chronic diseases. Moreover, it plays a critical role in preserving and even improving cognitive function throughout the lifespan. However, people with schizophrenia tend to be less engaged in physical activity programs than the general population and report a range of barriers such as pain, side effects of medications and negative symptoms.
The purpose of this trial is to evaluate the efficacy of an exercise-based intervention program among people with schizophrenia.
All individuals with schizophrenia were screened for eligibility. After verifying inclusion and exclusion criteria and after eligibility is confirmed, written informed consent must be obtained prior to randomization. Baseline patient characteristics (i.e., demographics, medical history, laboratory test results) have been collected and recorded for further assessment. Randomization was performed during the inclusion visit (T1). Randomization will be performed centrally using an internet-based system. The identification number (ID) and the treatment allocation will be assigned by the randomization system. Patients were randomized to physical activity group or usual care by a 2:1 allocation. After the randomization, all participants underwent the same battery of tests and questionnaires according to the study protocol.
All patients were involved in the usual care cognitive program. It was held in weekly 90-minute sessions in a Psychiatric Rehabilitation Center of the Healthcare District of Ferrara. Specialized psychiatric therapists conduct this program with groups of 5-10 participants, based on a Cognitive Remediation model. Each session consists of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks. Tasks include games and exercises (e.g., sudoku, crosswords), as well as discussions aimed at improving short- and long-term memory (i.e., repeating sequences of words and numbers), executive functions, and social cognition, with progressive adaptation of task difficulty. The total number of sessions is 50 for a duration of 12 months. In addition, the intervention arm was involved in a supervised exercise-based program. They could voluntarily participate in a variety of activities such as walking or Nordic walking groups, gentle gymnastics, soccer, swimming, and volleyball. Each activity was scheduled twice a week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Behavioral: Physical activity, Behavioral: Cognitive rehabilitation programParticipation in supervised activities such as walking or Nordic walking groups, gentle gymnastics, soccer, swimming, and volleyball. Each activity was scheduled twice a week. |
| Usual care group | Other | Behavioral: Cognitive rehabilitation programParticipants in the control group attended weekly 90-minute cognitive rehabilitation sessions according to the usual care procedure in this type of population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with schizophrenia for at least 1 year
- On antipsychotic medications with the same therapeutic regimen for at least 3 months before enrolment
- Free of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with physical activity sessions
Key exclusion criteria (2 listed)
- Recent modification of the therapeutic regimen
- Presence of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with physical activity sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityBi-weekly supervised physical activity intervention | Behavioural | Physical activity group |
| Cognitive rehabilitation programweekly 90-minute session consisting of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks. | Behavioural | Physical activity group, Usual care group |
Primary outcome
Peak Oxygen Uptake (VO2peak)
Time frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Measurement of cardiorespiratory fitness, reported as ml/kg/min and estimated through a moderate and perceptually regulated 1km treadmill walk test (1k-TWT) or through related short-forms (500m or 200m)
Body Mass Index (kg/m²)
Time frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Derived from the measurement of weight in kilograms and height in meters
Waist circumference (cm)
Time frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Measurement of waist circumference
Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Values range from 0 to >100, higher scores mean a better outcome
Frontal Assessment Battery (FAB)
Time frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)
Values range from 0 to18, higher scores mean a better outcome
1 secondary outcome
Adherence
Time frame: From date of enrollment until the date of the end of follow-up (up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Results publication: PubMed 35337370Mandini S, Morelli M, Belvederi Murri M, Grassi L, Masotti S, Simani L, Zerbini V, Raisi A, Piva T, Grazzi G, Mazzoni G. Adherence to a guided walking program with amelioration of cognitive functions in subjects with schizophrenia even during COVID-19 pandemic. BMC Sports Sci Med Rehabil. 2022 Mar 25;14(1):48. doi: 10.1186/s13102-022-00440-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianni Mazzoni, Professor study director
Università degli Studi di Ferrara
Simona Mandini, PhD principal investigator
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Cognitive rehabilitation program in people with Schizophrenia, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Mandini, PhD (+39 0535455963, simona.mandini@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Uptake (VO2peak) (time frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06044038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.