NCT03545958

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

May 22, 2018

Last Update Submit

August 14, 2020

Conditions

HypertensionCognitive DeclineVascular Cognitive Impairment

Keywords

Older adultsCommunity-basedHigh-intensity interval training (HIT)Mind-motor training

Outcome Measures

Primary Outcomes (2)

  • Composite score from Cambridge Brain Sciences Cognitive Battery

    Global cognitive functioning assessment

    Change from 0 to 6 months

  • Automated office Systolic Blood Pressure

    Resting blood pressure

    Change from 0 to 6 months

Secondary Outcomes (7)

  • 24-hour Blood Pressure monitoring

    Change from 0 to 6 months

  • Maximal oxygen uptake (VO2max)

    Change from 0 to 6 months

  • Trail-Making Test

    Change from 0 to 6 months

  • Memory

    0 to 6 months

  • Reasoning

    0 to 6 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Dual-Task Gait Velocity

    0 to 6 months

  • Dual-Task Gait Step Length

    0 to 6 months

  • Dual-Task Gait Variability

    0 to 6 months

Study Arms (2)

High-intensity Interval Training (HIT)

EXPERIMENTAL

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.

Behavioral: High-intensity Interval Training (HIT)

Moderate-intensity Continuous Training (MCT)

ACTIVE COMPARATOR

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.

Behavioral: Moderate-intensity Continuous Training (MCT)

Interventions

High-intensity Interval Training (HIT)BEHAVIORAL

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.

High-intensity Interval Training (HIT)
Moderate-intensity Continuous Training (MCT)BEHAVIORAL

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.

Moderate-intensity Continuous Training (MCT)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University, Western Centre for Public Health and Family Medicine

London, Ontario, N6G 2M1, Canada

Location

Related Publications (1)

  • Boa Sorte Silva NC, Petrella AFM, Christopher N, Marriott CFS, Gill DP, Owen AM, Petrella RJ. The Benefits of High-Intensity Interval Training on Cognition and Blood Pressure in Older Adults With Hypertension and Subjective Cognitive Decline: Results From the Heart & Mind Study. Front Aging Neurosci. 2021 Apr 15;13:643809. doi: 10.3389/fnagi.2021.643809. eCollection 2021.

    PMID: 33935686DERIVED

MeSH Terms

Conditions

HypertensionCognitive Dysfunction

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert Petrella, MD, PhD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Research Coordinator will manage recruitment and enrolment of study participants, and will not be involved in either measurement or the intervention. Research personnel performing the outcome assessments and data analysis will be blinded to group allocation but it is not possible to blind participants and personnel delivering the interventions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

November 15, 2018

Primary Completion

March 21, 2020

Study Completion

March 21, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)