Walking improves the cognitive function of schizophrenic subjects
| ISRCTN | ISRCTN14763786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14763786 |
- Submission date
- 22/12/2020
- Registration date
- 26/01/2021
- Last edited
- 28/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Schizophrenia is a common and costly public health problem. 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 up to 15 years shorter than that of the general population. Several studies have found that individuals with schizophrenia have high levels of heart disease risk factors such as obesity, dyslipidaemia, smoking, high blood pressure, high blood sugar, physical inactivity and lower fitness 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 programmes for people with mental illness, delivered in primary healthcare settings.
For these reasons, this study aims to investigate the feasibility and adherence of a long-term, moderate-intensity physical activity program for individuals with schizophrenia and its effects on heart disease risk factors and cognitive function.
Who can participate?
Patients diagnosed with schizophrenia since at least 1 year and taking the same antipsychotic medications for at least 3 months
What does the study involve?
Participants will be assigned to a guided walking group or to a cognitive rehabilitation program.
The guided walking program will take place twice a week, under the supervision of exercise physiologists and with the support of health workers. The walking sessions of 1-hour duration will be carried out outdoors and on flat ground. To motivate and enhance compliance, a monthly meeting on the importance of regular physical activity will be organized.
The Cognitive Rehabilitation Program will be held in weekly 90-minutes sessions in a Psychiatric Rehabilitation Center of the Healthcare District of Ferrara and conducted by a specialized psychiatric therapist. This program will be carried out in 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 (e.g. repeating sequences of words and numbers), executive functions, social cognition, with a progressive adaptation of task difficulty.
What are the possible benefits and risks of participating?
The researchers have proposed the walking activity because it is feasible for most of the people, it is safe, cheap and requires no special equipment. They also chose walking because it can be performed in a group and the mental health benefits of regular physical exercise are observed. The researchers previously showed that a 6-12 months program of guided walking was followed by a significant reduction of heart disease risk in a large population of sedentary adults. This study aims to document the possibility of extending to these patients the reduction of heart disease risk factors that follow prolonged periods of physical activity. The researchers believe that there are no particular risks deriving from participation in the walking program proposed.
Where is the study run from?
The study is conducted by the Center for Exercise Science and Sports and the Institute of Psychiatry of the University of Ferrara (Italy) in collaboration with the Public Mental Health Department of the Local Healthcare Company. The walking session will be carried out in public green spaces.
When is the study starting and how long is it expected to run for?
January 2013 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mandini Simona, PhD
simona.mandini@unife.it
Dr Belvederi Murri Martino, MD
martino.belvederimurri@unife.it
Contact information
Scientific
via Gramicia, 35
Ferrara
44121
Italy
 ORCID ID |
0000-0001-8569-6702 |
|---|---|
| Phone | +39 (0)532455963 |
| mndsmn@unife.it |
Scientific
Via Fossato di Mortara 64/A
Ferrara
44121
Italy
| ORCID ID |
0000-0002-7262-3528 |
|---|---|
| Phone | +39 (0)532 455852 |
| blvmtn@unife.it |
Study information
| Study design | Non-randomized intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Improvement of Cognitive functions in sedentaRy schizophrEnic subjects following 1-year of guided Walking (CREW): a pilot study |
| Study acronym | CREW |
| Study objectives | In the general population, regular physical activity is effective at improving cognitive function and reducing cardiovascular risk factors. |
| Ethics approval(s) | Approved 30/05/2013, Ethics Committee of the University of Ferrara (Comitato Etico di Area Vasta Emilia Centro (CE-AVEC), Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant’Orsola Malpighi, via Giuseppe Massarenti 9, 40138 Bologna, Italy; +39 (0)532239990; urp@ospfe.it), ref: 22-13 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | Forty sedentary patients diagnosed with schizophrenia are allocated to a 1-year Guided Walking program (GW n=28), consisting of two walking sessions per week, or to a Cognitive Rehabilitation program (CR n=12). Participants were allowed to choose the mode of treatment. The guided walking groups take place twice a week, under the supervision of exercise physiologists and with the support of health workers. The walking sessions are carried out outdoors and on flat ground. To motivate subjects and enhance compliance, monthly meetings on the importance of regular physical activity are held. The Cognitive Rehabilitation Program is held in weekly 90-minutes 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 (e.g. repeating sequences of words and numbers), executive functions, social cognition, with progressive adaptation of task difficulty. The total number of sessions is 50 for a duration of 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Feasibility was evaluated through the number of dropouts between baseline the end of the study 2. Adherence was measured by the number of walking sessions attended by the participants during the one year program (using patient records) 2. Cognitive function assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP) and the Frontal Assessment Battery (FAB) at baseline and after one year. |
| Secondary outcome measures | Cardiovascular risk factors were evaluated only in the subjects that followed the walking program (at baseline and after 1-year, at the end of the walking program): 1. Blood pressure (mmHg, sphygmomanometer) 2. Anthropometric variables - height (m), weight (kg), BMI (kg/m² and waist circumference (cm) 3. VO2peak was indirectly determined using the 1-kilometer walking test (1k-WT). Five minutes of slow walking preceded the test. Subjects were instructed to select a pace that they could maintain for 10 to 20 min at a moderate perceived exercise intensity, (11–13 on the 6–20 Borg scale). Heart rate was monitored continuously using a Polar Accurex Plus heart rate monitor (Polar Electro, Kempele, Finland). The equation for VO2 peak determination considering age, BMI, HR and time to complete the 1 k-TWT was then applied |
| Overall study start date | 01/01/2013 |
| Completion date | 22/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Patients diagnosed with schizophrenia since at least 1 year 2. On antipsychotic medications with the same therapeutic regimen for at least 3 months before enrolment 3. Free of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with the walking activity |
| Key exclusion criteria | 1. Recent modification of therapeutic regimen 2. Presence of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with the walking activity |
| Date of first enrolment | 13/11/2017 |
| Date of final enrolment | 20/12/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Gramicia 35
Ferrara
44121
Italy
Sponsor information
University/education
Neuroscience and Rehabilitation Department
via Luigi Borsari 46
Ferrara
44121
Italy
| Phone | +39 (0)532 293420 |
|---|---|
| lucia.manzalini@unife.it | |
| Website | http://www.unife.it/ |
"ROR" |
https://ror.org/041zkgm14 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/03/2022 | 28/03/2022 | Yes | No |
Editorial Notes
28/03/2022: Publication reference added.
18/08/2021: The intention to publish date has been changed from 01/02/2021 to 31/12/2021.
07/01/2021: Trial’s existence confirmed by Servizio Sanitario Regionale Emilia-Romagna
