Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Physical Exercise: Measure the impact of physical exercise in the cognition of pacients diagnosed with Bipolar Disorder

Study summary

The goal of this clinical trial is to evaluate the impact of Physical Exercise (PE), as an adjuvant treatment, on the cognition of patients diagnosed with Bipolar Disorder who present cognitive impairments, as well as its impact on quality of life and functionality and its association with physiological variables.

Our specific goals are:

1. Evaluate the effect of PE on the neuropsychological functions of attention, memory, verbal fluency, executive function and processing speed in patients diagnosed with BD who present cognitive impairments in these domains.
2. To evaluate the effect of PE on the quality of life and functionality of patients diagnosed with BD, as well as possible associations with cognitive functions.
3. To evaluate possible correlations between physiological variables, such as cardiorespiratory indices, strength and body composition, and improvements in cognitive functions, quality of life and functionality.

Eligibility

Primary outcome measure(s)

• Montgomery-Asberg Depression Rating Scale (MADRS) — Baseline, Week 4, Week 8 and Follow-up (12 weeks)
  Scale used to assess the presence and intensity of depressive symptoms.
• Young Mania Rating Scale (YMRS) — Baseline, Week 4, Week 8 and Follow-up (12 weeks)
  Scale used to assess the presence and intensity of manic symptoms.
• Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) — Baseline only
  Screening scale for the presence of cognitive deficits. Suggested cutoff point is 14
• Screen for Cognitive Impairment in Psychiatry (SCIP) — Baseline only
  Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70
• Stroop Color-Word Test (Spreen and Strauss, 1998) — Baseline and Follow-up (12 weeks)
  Assessing mental flexibility and inhibitory control (attention and executive function)
• Verbal Fluency - F.A.S (Spreen and Strauss, 1998) — Baseline and Follow-up (12 weeks)
  Assessing verbal fluency, inhibitory control and the correct use of strategies (executive function)
• Trail Making Test (Spreen and Strauss, 1998) — Baseline and Follow-up (12 weeks)
  Assessing alternating attention
• Logical Memory I and II (Wechsler, 1997b) — Baseline and Follow-up (12 weeks)
  Assessing verbal memory
• List of Words (Wechsler, 1997a) — Baseline and Follow-up (12 weeks)
  Assessing learning capacity and attention
• Cardiovascular evaluation — Baseline and Follow-up (12 weeks)
  All patients will undergo an electrocardiogram computerized.
• Stress test on the treadmill — Baseline and Follow-up (12 weeks)
  A treadmill stress test will be performed.
• Respiratory gas exchange analysis (ergospirometric) — Baseline and Follow-up (12 weeks)
  A computerized gas exchange analysis system will be used (CPX/ULTIMA, Medgraphics®, Saint Paul, MN, USA)
• Isokinetic Strength Test — Baseline and Follow-up (12 weeks)
  The isokinetic test will be performed on the lower limbs (extensor and flexor muscles of the knee joints) on the dominant (R) and non-dominant (ND) leg at an angular velocity of 60 s -1 using a computerized isokinetic dynamometer (Biodex®, Inc . USA).
• Body composition by bioimpedance — Baseline and Follow-up (12 weeks)
  Body composition measurements will be obtained by the non-invasive indirect bioimpedance method using a scale
• Anthropometric measurements (skinfolds) and calculation of body composition — Baseline and Follow-up (12 weeks)
  Body mass (BM) will be measured on a Filizola mechanical scale, with an accuracy of 0.1 kg. Height will be determined using a stadiometer, attached to the scale, with an accuracy of 0.1cm (Gordon et al., 1988). Body composition will be determined using the skinfold thickness technique.
• One Repetition Maximum Test (1RM) — Baseline and Follow-up (12 weeks)
  The exercises to be tested are the seated bench press (pectoral muscles), leg-press (quadriceps and glutes), rowing (dorsal muscles), standing knee bending chair (hamstrings), abdominal (rectus and abdominal obliques).
• Wechsler Abbreviated Scale of Intelligence (WASI) — Baseline and Follow-up (12 weeks)
  delivers an estimation of a student's general intellectual ability by measuring the verbal, nonverbal, and general cognition of individuals from 6 to 89 years of age.
• Digit Span Memory Test — Baseline and Follow-up (12 weeks)
  short test that evaluates a person's memory and cognitive status
• Cognitive Emotion Regulation Questionnaire (CERQ) — Baseline and Follow-up (12 weeks)
  Questionnaire measuring cognitive coping strategies
• Difficulties in Emotion Regulation Scale (DERS) — Baseline and Follow-up (12 weeks)
  Instrument measuring emotion regulation problems

Trial sites (1)

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