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Improving brain health in at risk populations with aerobic exercise

Aerobic exercise to improve cerebrovascular function, mood and cognition in middle-aged and older physically inactive overweight/obese adults

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000988156
Acronym
ACE Study
Enrollment
28
Registered
2019-07-11
Start date
2019-06-01
Completion date
2020-02-28
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dementia is the second leading cause of death in Australia and its rate is expected to double in the next 20 years. Obesity, physical inactivity, cardiovascular diseases and other chronic diseases can reduce the function of the blood vessels in the brain, which may subsequently decrease cognitive function and mood, which may lead to the development of dementia. Recent evidence suggests that aerobic exercise, such as walking, may improve the health of blood vessels in the brain, potentially also improving cognition and mood. Accordingly, we will undertake a 16 week randomised control trial that will investigate the effects of aerobic exercise training on brain circulatory function, mood and cognition in a physically inactive, middle-age to older (50-80 years old) and overweight/obese (body mass index > 25kg/m2) population, with the hypothesis that exercise training will improve cognition and mood in this cohort by improving cerebrovascular function, as well as improving general health and wellbeing.

Interventions

Aerobic exercise The objective of this research is to investigate the effects of regular aerobic exercise on cerebrovascular function, mood and cognition in middle-aged to older adults. A randomised control trial that aims to determine whether a high or low level of aerobic exercise training for 16 weeks can improve cerebrovascular function, mood and cognition in a physically inactive, middle-aged to older, overweight and obese cohort who are at risk of cognitive decline and dementia. It is hypo

Aerobic exercise The objective of this research is to investigate the effects of regular aerobic exercise on cerebrovascular function, mood and cognition in middle-aged to older adults. A randomised control trial that aims to determine whether a high or low level of aerobic exercise training for 16 weeks can improve cerebrovascular function, mood and cognition in a physically inactive, middle-aged to older, overweight and obese cohort who are at risk of cognitive decline and dementia. It is hypothesised that both the higher levels of exercise training will improve cognition and mood in this cohort by improving cerebrovascular function, as well as improving cardiovascular function and general physiological and psychological markers of health. However, it is unknown if less aerobic exercise training will elicit any changes in cognition and mood by improving cerebrovascular function. Hence, the aim here is to determine the optimal amount of aerobic exercise training to improve the aforementioned outcomes. We will aim to recruit one hundred and thirty-five participants for this study. Recruitment will occur via an approved media release that incorporates physical advertisement, social media and information on the USQ website. The individuals will be recruited from community organisations in and around Ipswich, Toowoomba and Brisbane. Respondents will initially be screened for suitability using the Exercise and Sports Science Australia (ESSA) Adult Pre-exercise Screening System, the Yale Physical Activity Survey and a medical history questionnaire to determine whether participants meet the inclusion and/or exclusion criteria. Once participants are recruited, voluntary written informed consent will be obtained prior to any assessment being performed and their allocation to one of the two arms of the study at a 2 is to 1 ratio (intervention:control). Further, participants will be asked to complete a nutritional questionnaire at 0 and 16 weeks, so that this can be assessed and that any effects that are noted throughout the study are due to the exercise intervention and not due to changes in nutritional behaviour. The two arms of this study will consist of a wait-list (control group), which will not participate in any exercise training, and a second arm (the exercise group) that will participate in 2 – 4 aerobic exercise sessions per week. Participants that are allocated to the exercise arm will participate in aerobic exercise training for either two, three or four days per week for 16 weeks (i.e., the participant can choose how many sessions they attend). These sessions will be conducted as supervised group sessions run by student exercise physiologists in the presence of an accredited Clinical Exercise Physiologist at the University of Southern Queensland Ipswich Campus. Participants in the second arm or exercise arm of the study can attend any of these sessions, as long as they participate in a minimum of two sessions per week. All sessions will last for 40 min, incorporating both a 5-min gentle warm-up and cool-down. The body of the sessions will be performed at a moderate intensity (Borg RPE 5-6), vigorous-high intensity (Borg RPE 7-8) or a mix of the two. Participants will be requested to perform these exercise sessions at a higher intensity every four weeks from the previous four weeks (this will be based on the Borg rating of perceived exertion (CR-10) scale). These sessions will incorporate steady-state aerobic exercise (i.e. walking), circuit training or a mix of the two types of training. Once informed about the study and its requirements, by providing potential participants with a participant information sheet, participants that meet part of the inclusion criteria will attend USQ Ipswich for baseline screening and testing. Prior to the start of any testing during visit 1, informed consent will be first voluntarily obtained and, once acknowledged, testing and screening will commence. These visits will incorporate the following methods: • Cerebrovascular responsiveness to hypercapnia and cognitive stimuli (NIH Toolbox, Trail Making Task) using transcranial Doppler sonography; • Profile of Mood States to ascertain current mood; • Anthropometry, determined by body weight and height (body mass index calculation), waist and hip circumferences (waist to hip ratio calculation) and Dual-energy X-ray absorptiometry (DEXA) which will ascertain body composition of total fat mass, lean mass, body fat percentage, and bone mineral content and density; • Systolic and diastolic blood pressure and arterial elasticity will be measured non-invasively using a Research Cardiovascular Profiling System; • Biomarker analyses after blood is collected; and • Exercise capacity will be assessed using a 6 minute walk test at 0 and 16 weeks and handgrip strength will be determined using hand dynamometry.

Sponsors

University of Southern Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Be aged 50-80 years Be physically inactive Have a body mass index >25 kg/m2 (we will calculate this) Have blood pressure below 160/100mmHg (we will determine this at the screening visit) Have an adequate ultrasound signal (we will determine this at the screening visit). Not have heart, kidney or liver disease (excluding fatty liver disease), cancer or a neurological disorder (e.g. stroke) Not taking insulin, anticoagulants or hormone replacement therapy

Exclusion criteria

Cognitive impairment and/or dementia Less than 150 minutes of moderate to vigorous intensity exercise/week BMI greater than 25 kg/m2 resting blood pressure equal to or less than 160/100mmHg Chronic kidney disease Chronic liver disease (excluding fatty liver disease) Coronary heart disease Congestive heart failure Atrial fibrillation Prior myocardial infarction Carcinoma (unless in remission or similar) Stroke Aneurysm Epilepsy Multiple sclerosis Parkinson’s disease Neuropathies Presence of a fistulae Smoker Prescribed insulin, hormone-replacement therapy, oral anticoagulants Middle cerebral artery signal absent on Doppler ultrasound

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026