Improving Functional Disability and Cognition in Parkinson Disease: Randomized Controlled Trial
Condition: PARKINSON DISEASE (Disorder)
MeSH terms: Parkinson Disease; Disease
Study type: Interventional

Summary: 
      The study design was a parallel-group randomized trial with equal randomization. Recruitment
      and enrollment were conducted between June 2012 and January 2013. At base-line, clinical,
      cognitive and functional data was collected. Afterwards, the participants were randomly
      allocated to either the REHACOP group or the Control group. During 3 months the intervention
      with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate
      the changes in clinical, cognitive and functional measures. Post-treatment assessment
      (finished by June 2013) was performed within the first week after completing the
      intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at
      changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological
      and neuroimaging assessements was also performed.

      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to
      improve cognition, clinical symptoms and functional disability of patients with Parkinson
      disease (PD).
    

Detailed description: 
      Assessment protocol:

      - Cognitive Evaluation: The cognitive battery included assessments to evaluate processing
      speed, verbal learning and memory, visual learning and memory and executive functioning. All
      cognitive measures were converted into Z-scores based on the pooled PD group, and the sign of
      some measures was adjusted so that higher scores indicated better cognitive performance. All
      composite cognitive domains maintained satisfactory internal consistency. Processing Speed
      (Cronbach's α = 0.85) was quantified based on the Trail Making Test-A and Salthouse Letter
      Comparison Test. For verbal learning and memory (α = 0.88), learning and long-term recall
      performance on the Hopkins Verbal Learning Test (version 2 at baseline and 4 at
      post-treatment) were utilized. For visual learning and memory (α = 0.96), learning and
      long-term recall performance on the Brief Visual Memory Test (version 1 at baseline and 3 at
      post-treatment) were used (α = 0.96). Executive functioning (α = 0.78) was determined based
      on the Stroop test, using the word-color and interference scores.

      Theory of mind (TOM). The strange stories test (Happé test) was administered to evaluate TOM.
      Four different stories (concerning double bluff, mistakes, persuasion and white lies) were
      administered at baseline and follow-up, and they were summed into a total TOM score with a
      possible range of 0 to 8. Higher scores indicate better TOM.

        -  Premorbid intelligence quotient and cognitive reserve. The Accentuation Reading Test
           (TAP), the Spanish version of the National Adult Reading Test (NART), was administered
           to calculate an estimation of each patient´s premorbid intelligence. The scale ranged
           from 0 to 30. Cognitive reserve was estimated using the Cognitive Reserve questionnaire.
           This 15-item multiple-choice questionnaire includes questions about education/culture,
           working activity, leisure and hobbies, physical activities and social activities. Higher
           scores indicate a better cognitive reserve, and the scale ranged from 0 to 26.

        -  Global cognitive status. The Mini-Mental State Examination (MMSE) was administered to
           obtain a general mental status score.

        -  Medication use. Medications, dosages and dose frequencies were used to calculate the
           levodopa-equivalent daily dose (mg/day) (LEDD).

        -  PD assessment. The Unified Parkinson's Disease Rating Scale and the Hoehn & Yahr scale
           were used for the assessment of the course and stage of the disease.

        -  Depressive symptoms. Geriatric Depression Scale (GDS-15) includes 15 items. Higher
           scores represent a higher degree of depression (range from 0 to 15).

        -  Neuropsychiatric symptoms. The NPI-Q was administered to evaluate neuropsychiatric
           symptoms. The test includes 10 items (delusions, hallucinations, agitation/aggression,
           depression/dysphoria, anxiety, euphoria, apathy, disinhibition, irritability and
           aberrant motor behavior). These sub-scales were summed into a total score with a
           possible range of 0 to 120. Higher scores indicate more frequent and severe
           neuropsychiatric symptoms.

        -  Apathy. The Lille apathy rating scale consists of 33 items, including 9 sub-scales
           (everyday productivity, interests, taking initiative, novelty seeking/motivation,
           emotional responses, concern, social life and self-awareness). These sub-scales were
           summed into a total apathy score with a possible range of -36 to 36. Lower scores
           indicate less apathy.

        -  Functional disability. Functional disability was self administered using the World
           Health Organization Disability Assessment Schedule II (WHO-DAS II), short version (12
           items).

      Description of the intervention:

        -  REHACOP is a structured program using paper-pencil tasks and it is based on the
           principles of restoration, compensation and optimization with a gradually increasing
           level of cognitive effort and demand. REHACOP trains different cognitive domains, such
           as attention, memory, processing speed, language, executive functioning and social
           cognition. Additionally, the program includes one unit related to functional outcome:
           activities of daily living. REHACOP includes up to 300 different tasks hierarchically
           organized into at least three levels of difficulty and subtypes of abilities. Several
           tasks are timed, so processing speed is trained throughout various modules. Once a basic
           cognitive strategy has been trained and well acquired, the therapist transitions the
           program to the next level. The program format allows for either individual or group
           sessions (between 5 and 8 patients per group), although for the purpose of this study,
           group sessions were chosen. In this study, two psychologists conducted the REHACOP group
           attending 60-minute-long sessions 3 days per week at Parkinson Disease Association
           Biskay (ASPARBI) (two groups) or the Hospital of Galdakao (one group). Specifically,
           REHACOP group remediation with PD patients consisted of: Attention unit (4 weeks)
           training sustained, selective, alternant and divided attention; Memory unit (3 weeks)
           focusing on visual and verbal learning, recall and recognizing memory; Language unit (3
           weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension,
           abstract language; Executive functions unit (2 weeks) training cognitive planning,
           proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind,
           social reasoning and moral dilemmas.

        -  Occupational Activities: The Control group consisted of occupational group activities
           conducted by a psychologist at ASPARBI. The activities included drawing, reading the
           daily news and constructing using different materials (such as paper or wood). These
           activities were accomplished in a group format and with the same frequency as the
           implementation of REHACOP in the experimental group.

      A subset of the sample will also complete a pre and post neuroimaging to evaluate changes in
      structural and functional brain activation.
    

Intervention name(s): cognitive remediation program: REHACOP; Occupational Therapy
Intervention type(s): Other; Other
Intervention description(s): Specifically, REHACOP group remediation with PD patients consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas.; The activities included drawing, reading the daily news and constructing using different materials (such as paper or wood). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson disease, cognitive rehabilitation, REHACOP