- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03545958
The Heart & Mind Study
14 août 2020 mis à jour par: Robert Petrella, Western University, Canada
Exercise to Improve the Hearts and Minds of Canadian Older Adults With Hypertension: The Heart & Mind Study
Older adults with subjective cognitive decline (SCD) may represent a portion of the population experiencing early sings of cognitive decline.
Systolic hypertension is a major contributor to cognitive impairment.
High-intensity aerobic interval training (HIT) yields greater fitness and vascular health improvements compared to moderate-intensity aerobic continuous training (MCT).
No randomized controlled trials, however, have investigated the effects HIT or MCT on cognition in older adults with hypertension and SCD.
Much less is known regarding whether combining HIT or MCT with mind-motor training would culminate additive benefits to cognition.
Therefore, the overarching goal of our research is to deliver a group-based exercise program combining mind-motor training with HIT or MCT to older adults with hypertension and SCD.
Participants will be randomized into two groups.
Participants in both groups will receive 15 minutes of square stepping exercise (SSE) followed by either 45 minutes of HIT (N=70) or 45 minutes of MCT (N=70).
In total, both groups will exercise 60 min/day, 3 days/week for 6 months.
The effects of both interventions will be evaluated on systolic and diastolic office/ambulatory blood pressure and global and domain-specific cognitive functioning.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
140
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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Ontario
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London, Ontario, Canada, N6G 2M1
- Western University, Western Centre for Public Health and Family Medicine
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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
55 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 55 years of age or older;
- Present with controlled or uncontrolled stage 1 hypertension (seated, resting clinic SBP 140 to 179 mmHg and/or DBP 90 to 109 mmHg) as per Hypertension Canada's 2017 Guidelines;
- Have preserved instrumental activities of daily living (scoring >6/8 on the Lawton-Brody Instrumental Activities of Daily Living [IADL] scale);
- Present signs of SCD (defined as answering yes to the question: "Do you feel like your memory or thinking skills have gotten worse recently?");
- Report being concerned about SCD (defined as answering yes to the question: "If yes, are you concerned about the worsening of your memory or thinking skills?");
- Preserved objective cognitive performance (i.e., no signs of MCI or dementia) defined by scoring ≥ 26 on the Montreal Cognitive Assessment (MoCA);
- Must be able to provide written informed consent.
Exclusion Criteria:
- Present signs of objective cognitive impairment (i.e., signs of MCI or dementia), defined by scoring ≤ 25 on the MoCA combined with study physician consult;
- Present resting stage 2 hypertension (seated, resting clinic SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
- Present significant neurological conditions or psychiatric disorders (e.g., Parkinson's disease or stroke <1 year); 4) present history of severe cardiovascular conditions (e.g., recent [<1 year] myocardial infarction, left ventricular hypertrophy) and symptomatic cerebrovascular disease;
- Present significant orthopaedic conditions (e.g., severe osteoarthritis in the lower limbs);
- Present untreated clinical depression (i.e., score >15 on the Center for Epidemiologic Studies - Depression scale combined with study physician consult);
- Unable to comprehend the study letter of information. Participants will also be excluded for any other factors that could potentially limit their ability to fully participate in the study.
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: High-intensity Interval Training (HIT)
Participants in this groups will receive 15 minutes in the mind-motor training (i.e., Square-Stepping Exercise) followed by a 45-minute HIT intervention.
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Following the mind-motor training component, participants in the experimental group will then continue in the 45-minute HIT intervention, which will be composed by a 10-minute warm-up, a 25-minute core activity, and a 10-minute cool down.
The 25-minute core activity will be carried out based on a 4 x 4 minutes aerobic interval training model.
The intensity in each cycle will be prescribed at an individual level, and training heart rates will be determined via a sub-maximal excise testing at baseline and monitored during exercise using a wrist-based heart rate monitor (Suunto).
In order to ensure progression in aerobic training over the 6-month intervention, training heart rates will be recalculated at the intervention midpoint (i.e., 3 months), where a new sub-maximal exercise test will be performed.
Participants will exercise 60 minutes/day, 3 days/week for 6 months.
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Comparateur actif: Moderate-intensity Continuous Training (MCT)
Participants in this groups will receive 15 minutes in the mind-motor training (i.e., Square-Stepping Exercise) followed by a 45-min MCT intervention.
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After the mind-motor training component, participants in the comparison/control group will then continue in the 45-min MCT intervention, which will be composed by a 10-minute warm-up a 25-minute moderate-intensity continuous aerobic exercise training, and a 10-minute cool down.
The exercise intensity will be prescribed at an individual level, and training heart rates will be determined via a sub-maximal excise testing at baseline and monitored during exercise using a wrist-based heart rate monitor (Suunto).
In order to ensure progression in aerobic training over the 6-month intervention, training heart rates will be recalculated at the intervention midpoint (i.e., 3 months), where a new sub-maximal exercise test will be performed.
Participants will exercise 60 minutes/day, 3 days/week for 6 months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Composite score from Cambridge Brain Sciences Cognitive Battery
Délai: Change from 0 to 6 months
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Global cognitive functioning assessment
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Change from 0 to 6 months
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Automated office Systolic Blood Pressure
Délai: Change from 0 to 6 months
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Resting blood pressure
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Change from 0 to 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
24-hour Blood Pressure monitoring
Délai: Change from 0 to 6 months
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Ambulatory blood pressure assessment
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Change from 0 to 6 months
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Maximal oxygen uptake (VO2max)
Délai: Change from 0 to 6 months
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Cardiorespiratory fitness assessment
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Change from 0 to 6 months
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Trail-Making Test
Délai: Change from 0 to 6 months
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Executive Functioning assessment
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Change from 0 to 6 months
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Memory
Délai: 0 to 6 months
|
Composite measure derived from the Cambridge Brain Sciences cognitive battery (Hampshire, Highfield, Parkin, & Owen, 2012).
The composite score is derived from 4 cognitive tasks: Monkey Ladder (visuospatial working memory), Spatial Span (short-term memory), Digit Span (verbal working memory), and Paired Associates (visuospatial learning).
For each of the cognitive tasks, higher scores indicate better outcomes.
The scores from each task are standardized and averaged to generate a standardized composite measure of memory, i.e., z scores with a mean of 0 and a standard deviation of 1.
The standardized scores can range from negative infinity to positive infinity.
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0 to 6 months
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Reasoning
Délai: 0 to 6 months
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Composite measure from the Cambridge Brain Sciences cognitive battery.
The composite score is derived from 3 cognitive tasks: Grammatical Reasoning (verbal reasoning), Double Trouble (modified Stroop task), and Odd One Out (deductive reasoning).
For each of the cognitive tasks, higher scores indicate better outcomes.
The scores from each task are standardized and averaged to generate a standardized composite measure of reasoning, i.e., z scores with a mean of 0 and a standard deviation of 1.
The standardized scores can range from negative infinity to positive infinity.
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0 to 6 months
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Planning
Délai: 0 to 6 months
|
Composite measure from the Cambridge Brain Sciences cognitive battery.
The composite score is derived from 2 cognitive tasks: Spatial Planning (planning and executive function) and Token Search (working memory and strategy).
For each of the cognitive tasks, higher scores indicate better outcomes.
The scores from each task are standardized and averaged to generate a standardized composite measure, i.e., z scores with a mean of 0 and a standard deviation of 1.
The standardized scores can range from negative infinity to positive infinity.
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0 to 6 months
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Concentration
Délai: 0 to 6 months
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Composite measure from the Cambridge Brain Sciences cognitive battery.
The composite score is derived from 3 cognitive tasks: Rotations (mental rotation), Feature Match (feature-based attention and concentration), and Polygons (visuospatial processing).
For each of the cognitive tasks, higher scores indicate better outcomes.
The scores from each task are standardized and averaged to generate a standardized composite measure, i.e., z scores with a mean of 0 and a standard deviation of 1.
The standardized scores can range from negative infinity to positive infinity.
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0 to 6 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Dual-Task Gait Velocity
Délai: 0 to 6 months
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Dual-task velocity is measured in centimetres/second and will be assessed via an electronic walkway (GAITRite® System, 420 cm long, 90 cm wide; CIR Systems).
Participants will complete: 1) a single-task walking trial at their own pace; followed by two dual-task walking trials: 2a) walking while naming animals (at baseline) or vegetables (at study endpoint) and 2b) walking while subtracting serial sevens from 90 (at baseline) or 80 (at study endpoint).
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0 to 6 months
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Dual-Task Gait Step Length
Délai: 0 to 6 months
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Dual-task step length is measured in centimetres and will be assessed via an electronic walkway (GAITRite® System, 420 cm long, 90 cm wide; CIR Systems).
Participants will complete: 1) a single-task walking trial at their own pace; followed by two dual-task walking trials: 2a) walking while naming animals (at baseline) or vegetables (at study endpoint) and 2b) walking while subtracting serial sevens from 90 (at baseline) or 80 (at study endpoint).
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0 to 6 months
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Dual-Task Gait Variability
Délai: 0 to 6 months
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Dual-task gait variability is derived from cycle time variability, measured as the coefficient of variation (%) for cycle time, and will be assessed via an electronic walkway (GAITRite® System, 420 cm long, 90 cm wide; CIR Systems).
Participants will complete: 1) a single-task walking trial at their own pace; followed by two dual-task walking trials: 2a) walking while naming animals (at baseline) or vegetables (at study endpoint) and 2b) walking while subtracting serial sevens from 90 (at baseline) or 80 (at study endpoint).
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0 to 6 months
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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: Robert Petrella, MD, PhD, Study Principal Investigator
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 (Réel)
15 novembre 2018
Achèvement primaire (Réel)
21 mars 2020
Achèvement de l'étude (Réel)
21 mars 2020
Dates d'inscription aux études
Première soumission
22 mai 2018
Première soumission répondant aux critères de contrôle qualité
22 mai 2018
Première publication (Réel)
4 juin 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 août 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 août 2020
Dernière vérification
1 août 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 111686
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Hypertension
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National Taiwan University Hospital Hsin-Chu BranchRecrutementHypertension Essentielle | Hypertension, masquéTaïwan
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Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentInconnue
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University of Alabama at BirminghamTroy UniversityComplétéHypertension | Hypertension, résistante à la thérapie conventionnelle | Hypertension non contrôlée | Hypertension, blouse blancheÉtats-Unis
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Assistance Publique - Hôpitaux de ParisActif, ne recrute pasHypertension portale non cirrhotique intrahépatiqueFrance
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Vanderbilt University Medical CenterJohns Hopkins UniversityComplétéHypertension artérielle pulmonaire | Hypertension artérielle pulmonaire idiopathique | Hypertension artérielle pulmonaire associée | Hypertension artérielle pulmonaire héréditaireÉtats-Unis
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldComplétéHypertension artérielle pulmonaire idiopathique | Hypertension pulmonaire thromboembolique chroniqueRoyaume-Uni
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BayerComplété
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Centre Chirurgical Marie LannelongueInconnueHypertension pulmonaire thromboembolique chronique et hypertension artérielle pulmonaireFrance
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University of VermontInconnue
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AstraZenecaComplétéHypertension artérielle (hypertension).
Essais cliniques sur High-intensity Interval Training (HIT)
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University of Alabama at BirminghamInscription sur invitation
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Emory UniversityNational Football LeagueComplété