Parkinson's disease, exercise and cognitive training
| ISRCTN | ISRCTN52284448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52284448 |
| Secondary identifying numbers | DEP2014-53896-R |
- Submission date
- 23/03/2016
- Registration date
- 14/04/2016
- Last edited
- 22/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Parkinson’s disease (PD) is a long-term medical condition which is caused by the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). As well as the issues with movement, many patients with PD also experience problems with cognitive function (thinking, reasoning and memory). In the early stages of the disease medications can help to reduce the physical symptoms, but the effects of these drugs on cognitive function are not fully understood. Several studies have suggested that a combination of both physical exercise and cognitive training can help to improve cognitive function in PD patients more efficiently than cognitive training alone, however further research is needed in order to find out how effective this really is. The aim of this study is to find out whether a programme involving both physical exercise and cognitive training is more effective at improving cognitive function than cognitive training alone.
Who can participate?
Adults aged between 40 and 80 who have Parkinson’s disease with mild to moderate disability.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the second group take part in cognitive training alone. This involves completing a number of mental tasks on a computer of increasing difficulty. The difficulty levels are adapted for each patient. Those in the second group take part in cognitive training with exercise. This involves completing the cognitive training on a touch screen computer while walking on a treadmill. Two weeks before and after the training and again two months later, participants in both groups complete a number of assessments and questionnaires to test their cognitive and physical performance.
What are the possible benefits and risks of participating?
Participants may benefit from being able to improve their cognitive function. There are no notable risks involved with taking part in this study.
Where is the study run from?
University Hospital Complex of A Coruña (Spain)
When is the study starting and how long is it expected to run for?
December 2014 to February 2018
Who is funding the study?
Ministry of Economy and Competitiveness (Spain)
Who is the main contact?
Professor Miguel Fernández del Olmo
mafo@udc.es
Contact information
Scientific
Departamento de Educación Física e Deportiva
Facultade de Ciencias do Deporte e a Educación Física (INEF Galicia)
Avd. Ernesto Che Guevara 121, Pazos-Liáns
A Coruña
15179
Spain
 ORCID ID |
0000-0001-5325-503X |
|---|---|
| Phone | +34 981167000 |
| mafo@udc.es |
Study information
| Study design | Single-centre randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Effects of the combination of physical exercise and cognitive training on cognitive functions in patients with Parkinson's disease |
| Study acronym | EFECEP |
| Study objectives | Multimodal intervention of physical exercise and cognitive training will induce greater cognitive improvements compared with the unimodal intervention of cognitive training in Parkinson's disease patients. |
| Ethics approval(s) | Ethics committee of University of A Coruña, 30/12/2015, ref: 20/2014 |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Patients will be allocated randomly in two groups, a group of multimodal intervention (physical exercise + cognitive training) and a group of unimodal intervention (cognitive training). Group 1: Participants complete cognitive training alone. This involves completing computer tasks, individualized for the cognitive capacity, using the software SmartBrain (http://www.smartbrain.net/). Participants complete three sessions a weeks for eight weeks, lasting for around 64 minutes per session. Group 2: Participants complete the cognitive training whiles walking on a treadmill, by using touch screen technology. Participants complete three sessions a weeks for eight weeks, lasting for around 64 minutes per session. Two weeks before and after the training programs, clinical, motor, neuropsychogical and neurophysiological evaluations will be conducted. A two month follow up will also be performed. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Cognitive performance is measured using CDS (Cognitive Difficulties Scale), WAIS-III (Wechsler Adult Intelligence Scale-III), Digital Span Forward and backwards, Trail Making Test A and B, Stroop Test, Corsi Block, Verbal Fluency (FAS), Tower of London and Wilcoxin Card Sorting Test at 2 month before intervention, 2 weeks before intervention (baseline), 2 weeks post-intervention and two months post-intervention (follow-up) 2. Motor performance is measured using walk at comfortable speed, Time Up & Go and walk with dual-task at 2 month before intervention, 2 weeks before intervention (baseline), 2 weeks post-intervention and two months post-intervention (follow-up) 3. Quality of life is measured using ADLS (Activities of Dayly Living Scale), QOLS (Quality Of Life Scale) and IPAQ (International Physical Activity Questionnaire) at 2 month before intervention, 2 weeks before intervention (baseline), 2 weeks post-intervention and two months post-intervention (follow-up) |
| Secondary outcome measures | 1. Functional connectivity is measured using evoked related potentials at 2 weeks before intervention (baseline) and 2 weeks post-intervention 2. White matter is measured using diffusion tensor imaging at 2 weeks before intervention (baseline) and 2 weeks post-intervention |
| Overall study start date | 01/12/2014 |
| Completion date | 15/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged 40–80 years 2. Diagnosed with PD according to UK PD Society Brain Bank Criteria.26 3. Disease severity of Hoehn and Yahr (H&Y) stages I–III |
| Key exclusion criteria | 1. Significant cognitive impairment (Mini-Mental State Examination < 23) 2. Below average premorbid intelligence (vocabulary subtest, Wechsler Adult Intelligence Scale-III [WAIS-III] typical score < 40) 3. Major depression (GDS-15 > 10) 4. Severe auditory or visual deficits 5. Another psychiatric/neurological condition |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 01/06/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
A Coruña
15179
Spain
Sponsor information
University/education
Rúa da Maestranza, 9
A Coruña
15001
Spain
| Phone | +34 981167000 |
|---|---|
| reitor@udc.es | |
| Website | www.udc.es |
"ROR" |
https://ror.org/01qckj285 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Economy and Competitiveness, MINECO, MEC
- Location
- Spain
Results and Publications
| Intention to publish date | 06/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of study results in peer reviewed journals. |
| IPD sharing plan |
Editorial Notes
22/01/2018: The overall trial end date was changed from 01/02/2018 to 15/01/2018. Intention to publish date was changed from 31/12/2018 to 06/06/2018.
