- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03545958
The Heart & Mind Study
14 sierpnia 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
140
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ontario
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London, Ontario, Kanada, N6G 2M1
- Western University, Western Centre for Public Health and Family Medicine
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
55 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Composite score from Cambridge Brain Sciences Cognitive Battery
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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24-hour Blood Pressure monitoring
Ramy czasowe: 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)
Ramy czasowe: Change from 0 to 6 months
|
Cardiorespiratory fitness assessment
|
Change from 0 to 6 months
|
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Trail-Making Test
Ramy czasowe: Change from 0 to 6 months
|
Executive Functioning assessment
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Change from 0 to 6 months
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Memory
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dual-Task Gait Velocity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Robert Petrella, MD, PhD, study principal investigator
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
15 listopada 2018
Zakończenie podstawowe (Rzeczywisty)
21 marca 2020
Ukończenie studiów (Rzeczywisty)
21 marca 2020
Daty rejestracji na studia
Pierwszy przesłany
22 maja 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 maja 2018
Pierwszy wysłany (Rzeczywisty)
4 czerwca 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
18 sierpnia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 sierpnia 2020
Ostatnia weryfikacja
1 sierpnia 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 111686
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .