Plain English Summary
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
Prof Miguel Fernández del Olmo
Departamento de Educación Física e Deportiva
Facultade de Ciencias do Deporte e a Educación Física (INEF Galicia)
Avd. Ernesto Che Guevara 121
Effects of the combination of physical exercise and cognitive training on cognitive functions in patients with Parkinson's disease
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 committee of University of A Coruña, 30/12/2015, ref: 20/2014
Single-centre randomised parallel trial
Primary study design
Secondary study design
Randomised parallel trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
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.
Primary outcome measures
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 trial start date
Overall trial end date
Participant 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
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital Complex of A Coruña (Complexo Hospitalario Universitario de A Coruña)
As Xubias, 84
Ministerio de Economía y Competitividad
Ministry of Economy and Competitiveness, MINECO
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of study results in peer reviewed journals.
Intention to publish date
Participant level data
Available on request
Results - basic reporting