Exercise and Cognitive Training
31 mai 2018 mis à jour par: Susan Mcgurk, Boston University Charles River Campus
The purpose of this study is to evaluate the potential benefits of combining cognitive remediation and exercise in improving cognitive functioning and response to psychiatric rehabilitation.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Impaired cognitive functioning is a common feature of schizophrenia and other serious mental illnesses that is related to poorer psychosocial functioning and less benefit from psychiatric rehabilitation.
Research shows that cognitive remediation for persons with serious mental illness improves cognitive functioning and response to psychiatric rehabilitation.
There is also evidence that physical activity such as aerobic exercise confers a benefit to cognitive functioning in both clinical and general population samples.
The cognitive benefit of exercise is hypothesized to be the result of enhanced brain-derived neurotrophic factor (BDNF; a protein that promotes plasticity, reduces degeneration, and stimulates nerve cell survival).
However, the potential synergistic effects of cognitive remediation and exercise on cognitive functioning have not been investigated in persons with serious mental illness.
This pilot randomized controlled trial will evaluate the impact of adding a peer run exercise program to a standardized cognitive remediation program on cognitive functioning in 30 people with schizophrenia, schizoaffective disorder or bipolar disorder.
All study participants will receive a 10-week cognitive remediation program shown in previous research to improve cognitive functioning.
One-half (N = 15) of the participants will also receive a peer-led exercise program designed to promote cardiovascular fitness.
The primary research questions addressed are: 1) Does the addition of the exercise program to cognitive remediation lead to greater improvements in cognitive functioning than cognitive remediation alone?, and, 2) Are improvements in cognitive functioning mediated (explained) by exercise-induced increases in BDNF?
The results of this pilot study will inform the design of a larger, more definitive trial to evaluate the potential benefits of combining cognitive remediation and exercise in improving cognitive functioning and response to psychiatric rehabilitation.
Type d'étude
Interventionnel
Inscription (Anticipé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Boston University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- a DSM-5 diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder based on the Structured Diagnostic Interview for DSM-5;
- no changes in prescribed psychotropic medication dosage or type for at least 1 month;
- medical clearance from a physician to participate in the exercise program;
- currently exhibiting a sedentary lifestyle, as defined by exercising less than 3 days/wk for at least 20 minutes each time;
- no current active suicidal ideation; and 6) fluent in English.
Exclusion Criteria:
- positive screen for a major neurocognitive disorder (as indicated by a score below 23 on the Folstein Mini Mental Exam or a positive score on the HELPS Brain Injury Screening using only cognitive items for "P" items);
- DSM-5 diagnosis of substance use disorder other than nicotine or caffeine in the last 6 months, or bulimia within the last 6 months;
- body mass index greater than 45; a BMI of 45 was selected as the upper limit in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI at or less than 45; and
- for women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Exercise and Cognitive Remediation
The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down.
The experimental group will participate in the exercise intervention as well as cognitive remediation.
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The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down.
Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies.
One-hour sessions will be conducted 3 times per week for 10 weeks.
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Comparateur actif: Cognitive Remediation Only
Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies.
One-hour sessions will be conducted 3 times per week for 10 weeks.
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Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies.
One-hour sessions will be conducted 3 times per week for 10 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Composite Measure of Change in Neurocognitive functioning
Délai: post- 10 week intervention and 2 weeks after end of intervention
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The neurocognitive outcome variables will be assessed at baseline, the week following the 10-week program, and 2 weeks later.
Neurocognitive tests for primary outcome variables are from the MATRICS Neurocognition Committee for use with people with schizophrenia.
These include tests of 1) attention and vigilance, 2) verbal working memory, 3) verbal learning, 4) visual learning, and 5) information processing speed.
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post- 10 week intervention and 2 weeks after end of intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Susan McGurk, PhD, Boston University
- Chercheur principal: Michael Otto, PhD, Boston University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2015
Achèvement primaire (Réel)
1 novembre 2017
Achèvement de l'étude (Réel)
1 novembre 2017
Dates d'inscription aux études
Première soumission
18 décembre 2014
Première soumission répondant aux critères de contrôle qualité
22 décembre 2014
Première publication (Estimation)
29 décembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3636
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