About this trial
Cardiovascular diseases (CVD) are a leading cause of morbidity and mortality worldwide. While CVDs are predominantly diseases of aging, age itself does not predict CVD risk; people age at different rates. Frailty is a state of accelerated aging that increases the risk of adverse health outcomes. Frail people are at higher risk of developing CVDs, experiencing complications, and dying from these diseases than fit people of the same age. Indeed, frailty predicts the likelihood of developing CVD independently of traditional risk factors for CVD. It is known that older women are frailer than men and tend to express CVDs differently than men, but whether relationships between frailty and CVD are sex specific is unclear. It is possible that shared pathophysiological mechanisms such as chronic inflammation may help explain links between CVD and frailty. Importantly, the degree of frailty can be modified by lifestyle interventions. For example, sedentary lifestyles, food insecurity, and suboptimal dietary habits can exacerbate frailty whereas diet and exercise interventions can attenuate frailty.
The investigators propose that a comprehensive health strategy targeting diet and physical activity to reduce frailty will reduce the risk of cardiovascular disease (CVD), thereby promoting healthy aging. Engaging in physical activity (e.g. exercise) helps improve aerobic fitness, increase muscle mass, promote cardiac regeneration, enhance metabolic function, regulate blood pressure, improve insulin sensitivity, reduce inflammation (a key frailty mechanism), and lessen frailty. High-quality dietary protein is essential to maintain muscle mass/function, preserve mobility, attenuate inflammation, and reduce frailty. Packed with antioxidants such as anthocyanins and flavonoids, with high levels of fiber, vitamins, and minerals, blueberries, a local Nova Scotian food, can help lower blood pressure, improve blood vessel function, reduce inflammation, and help the body utilize dietary protein. These are critical aspects of a strong heart and healthy aging. To date, many frailty intervention studies have been limited by small sample sizes, underrepresentation of women, and/or by testing individual lifestyle modifications rather than synergistic effects; additionally, none have investigated how reducing frailty impacts cardiovascular outcomes. Our goal is to determine if a year-long multidomain intervention of protein, blueberries, and exercise reduces frailty and cardiovascular disease risk in older at-risk Nova Scotians of both sexes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be 65 years of age or above
Must be willing to participate in a low to moderate exercise program
Disqualifiers
Medical and cognitive conditions that prevent participation in the intervention
Allergies and or dislike of blueberries and/or protein powder
Trial design
Parallel
Treatments tested in this trial
intervention of protein, blueberries
Dietary supplementIntervention of 30g/day (1 scoop) of a colorless, tasteless whey protein isolate powder supplement and 1 cup (150 grams) of blueberries per day. An alternate suitable protein powder such as pea protein isolate powder, pumpkin, casein, rice etc. is available for participants who do not eat milk products.
Exercise training
BehavioralThree 60-minute multimodal exercise sessions per week. Exercise interventions will be individualized to each participant based on their fitness level as per recommended guidelines for older adults. Each session will include a warm-up and cool-down (\~5 minutes each), 30 minutes of moderate intensity aerobic exercise and 20 minutes of moderate intensity resistance training.
Treatment groups
Trial outcomes
Primary outcomes
Cardiovascular Risk - Echocardiography
Ejection fraction will be measured in M-mode and global longitudinal strain will be assessed.
Inflammatory Markers
Plasma will be obtained from blood samples collected at two time points, pre- and post-intervention. A multiplex assay will be used to quantify anti-inflammatory and inflammatory cytokines in the plasma sample. The following cytokines will be quantified (pg/ml): APRIL / TNFSF13, BAFF / TNFSF13B, sCD30 / TNFRSF8, sCD163, Chitinase-3-like, gp130 / sIL-6Rβ, IFN-α2, IFN-β, IFN-γ, IL-2, sIL-6Rα, IL-8, IL-10, IL-1, IL-12 (p40), IL-12 (p70), IL-19, IL-20, IL-22, IL-26, IL-27 (p28), IL-28A / IFN-λ2, IL-29/IFN-λ1, IL-32, IL-34, IL-35, LIGHT / TNFSF14, MMP-1, MMP-2, MMP-3, Osteocalcin, Osteopontin, Pentraxin-3, sTNF-R1, sTNF-R2, TSLP, TWEAK / TNFSF12.
Frailty
Frailty will be assessed using a Frailty Index. The frailty index will be constructed based on deficit accumulation using established techniques
Cardiovascualr Risk: Blood pressure
Resting blood pressure (systolic/diastolic) will be assessed using an automated blood pressure cuff. Blood pressure will be measure in mm of Hg.
Secondary outcomes
Muscular Health: Lower Body Strength
Lower body strength will be assessed using the 30 second sit to stand task. The number of times an individual can stand from a seated position will be recorded.
Functional Fitness
Assessed using a 6-minute walk test (6MWT). Total distance in meters will be recorded.
Balance
Single leg balance test. Total time in seconds will be recorded.
Mobility: Lower Body
Lower body mobility will be assessed using the sit \& reach test. Reach distance will be measured in centimeters.
Other outcomes
Safety Outcomes
Safety outcomes will be determined by recording the total number of adverse events that occur over the duration of the exercise program. This will be divided by the number of participant hours to determine the number of adverse events/participant hours.
Study Adherence
Exercise attendance and blueberry/protein consumption will be monitored using an electronic participant logbook.
Incident Outcomes Related to Frailty
Impaired balance, falls, hip fractures, changes in like-space, social engagement.
CVD
Angina, heart attack, stroke.
Sponsors and contacts
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Nova Scotia Health Authority
Lead sponsor
Dalhousie University
Collaborator