- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03545958
The Heart & Mind Study
14 agosto 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Tipo di studio
Interventistico
Iscrizione (Effettivo)
140
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
55 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Comparatore attivo: 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.
|
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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite score from Cambridge Brain Sciences Cognitive Battery
Lasso di tempo: Change from 0 to 6 months
|
Global cognitive functioning assessment
|
Change from 0 to 6 months
|
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Automated office Systolic Blood Pressure
Lasso di tempo: Change from 0 to 6 months
|
Resting blood pressure
|
Change from 0 to 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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24-hour Blood Pressure monitoring
Lasso di tempo: Change from 0 to 6 months
|
Ambulatory blood pressure assessment
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Change from 0 to 6 months
|
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Maximal oxygen uptake (VO2max)
Lasso di tempo: Change from 0 to 6 months
|
Cardiorespiratory fitness assessment
|
Change from 0 to 6 months
|
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Trail-Making Test
Lasso di tempo: Change from 0 to 6 months
|
Executive Functioning assessment
|
Change from 0 to 6 months
|
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Memory
Lasso di tempo: 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
Lasso di tempo: 0 to 6 months
|
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
Lasso di tempo: 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
Lasso di tempo: 0 to 6 months
|
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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dual-Task Gait Velocity
Lasso di tempo: 0 to 6 months
|
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
Lasso di tempo: 0 to 6 months
|
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
Lasso di tempo: 0 to 6 months
|
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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Robert Petrella, MD, PhD, study principal investigator
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 novembre 2018
Completamento primario (Effettivo)
21 marzo 2020
Completamento dello studio (Effettivo)
21 marzo 2020
Date di iscrizione allo studio
Primo inviato
22 maggio 2018
Primo inviato che soddisfa i criteri di controllo qualità
22 maggio 2018
Primo Inserito (Effettivo)
4 giugno 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 agosto 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 agosto 2020
Ultimo verificato
1 agosto 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 111686
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .