Parkinson's disease, exercise and cognitive training

• Register: ISRCTN
• Last refreshed on: 19 February 2018
• Main ID: ISRCTN52284448
• Date of registration: 14/04/2016
• Prospective Registration: Yes
• Primary sponsor: University of A Coruña
• Public title: Parkinson's disease, exercise and cognitive training
• Scientific title: Effects of the combination of physical exercise and cognitive training on cognitive functions in patients with Parkinson's disease
• Date of first enrolment: 01/06/2016
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN52284448
• Study type: Interventional
• Study design: Single-centre randomised parallel trial (Quality of life)

Countries of recruitment

Spain

Contacts

• Name: Miguel Fernández del Olmo

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's disease
Nervous System Diseases
Parkinson's disease

Intervention(s)

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(s)

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(s)

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

Secondary ID(s)

DEP2014-53896-R

Source(s) of Monetary Support

Ministerio de Economía y Competitividad

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 15/01/2018