- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03545958
The Heart & Mind Study
14. august 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Aktiv 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.
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Composite score from Cambridge Brain Sciences Cognitive Battery
Tidsramme: Change from 0 to 6 months
|
Global cognitive functioning assessment
|
Change from 0 to 6 months
|
Automated office Systolic Blood Pressure
Tidsramme: Change from 0 to 6 months
|
Resting blood pressure
|
Change from 0 to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
24-hour Blood Pressure monitoring
Tidsramme: Change from 0 to 6 months
|
Ambulatory blood pressure assessment
|
Change from 0 to 6 months
|
Maximal oxygen uptake (VO2max)
Tidsramme: Change from 0 to 6 months
|
Cardiorespiratory fitness assessment
|
Change from 0 to 6 months
|
Trail-Making Test
Tidsramme: Change from 0 to 6 months
|
Executive Functioning assessment
|
Change from 0 to 6 months
|
Memory
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Concentration
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Dual-Task Gait Velocity
Tidsramme: 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
Tidsramme: 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
|
Dual-Task Gait Variability
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Robert Petrella, MD, PhD, Study Principal Investigator
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. november 2018
Primær fullføring (Faktiske)
21. mars 2020
Studiet fullført (Faktiske)
21. mars 2020
Datoer for studieregistrering
Først innsendt
22. mai 2018
Først innsendt som oppfylte QC-kriteriene
22. mai 2018
Først lagt ut (Faktiske)
4. juni 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 111686
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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