Condition category
Nervous System Diseases
Date applied
23/03/2016
Date assigned
14/04/2016
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
mafo@udc.es

Trial website

Contact information

Type

Scientific

Primary contact

Prof Miguel Fernández del Olmo

ORCID ID

http://orcid.org/0000-0001-5325-503X

Contact details

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
+34 981167000
mafo@udc.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DEP2014-53896-R

Study information

Scientific title

Effects of the combination of physical exercise and cognitive training on cognitive functions in patients with Parkinson's disease

Acronym

EFECEP

Study hypothesis

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

Ethics committee of University of A Coruña, 30/12/2015, ref: 20/2014

Study design

Single-centre randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Drug names

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

01/12/2014

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

60

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

01/06/2016

Recruitment end date

01/06/2017

Locations

Countries of recruitment

Spain

Trial participating centre

University Hospital Complex of A Coruña (Complexo Hospitalario Universitario de A Coruña)
As Xubias, 84
A Coruña
15179
Spain

Sponsor information

Organisation

University of A Coruña

Sponsor details

Rúa da Maestranza
9
A Coruña
15001
Spain
+34 981167000
reitor@udc.es

Sponsor type

University/education

Website

www.udc.es

Funders

Funder type

Government

Funder name

Ministerio de Economía y Competitividad

Alternative name(s)

Ministry of Economy and Competitiveness, MINECO

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Results and Publications

Publication and dissemination plan

Planned publication of study results in peer reviewed journals.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes