An interventional study of intervention of protein, blueberries and Exercise training in Cardiovascular Disease and Frailty, sponsored by Nova Scotia Health Authority. Recruiting at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Prevention
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.
The proposed trial is a randomized control trial (RCT) investigating the synergistic effects of protein, blueberries, and resistance plus aerobic training on frailty and cardiovascular health in at-risk Nova Scotians. As frailty and CVD are closely linked, the investigators propose that lifestyle interventions to reduce frailty will improve cardiovascular health in at risk individuals. Studies designed to reduce frailty to date are limited by testing individual lifestyle modifications rather than a prescribed package combining theoretically synergistic treatments and none have investigated effects on cardiovascular health. The investigators have developed a novel packaged intervention of exercise plus protein and blueberries based on their effectiveness as individual treatments and potential for synergy based on complementary biological mechanisms. The investigators will determine whether this prescribed STRONG intervention reduces frailty and improves cardiovascular health in older Nova Scotians by comparing the treatment group with a control group who will receive their usual medical care, as in most pragmatic trials that are performed to determine if an intervention can improve current practice. Usual medical care may differ between participants; it may or may not include diet and exercise recommendations from their physicians. The trial design for the STRONG study is a pragmatic randomized controlled trial on year in length with an additional year of follow-up. The participants will be randomly assigned to one of two groups for 12 months: the control group (n=120 who will receive usual care), or the treatment group (n=120; who will receive the STRONG intervention of protein, blueberries, and exercise). The control group will be tested for fitness, frailty, and cardiovascular health including blood biomarkers and cardiac function (echocardiography). Both groups will be given the option to review their assessment results at each timepoint. Exercise intensity will be monitored using the Category Ratio 10 (CR10) ratings of perceived exertion scale. On this scale, exercise should elicit a score of 4-5. All participants will be given a copy of the CR10 scale and taught how to use it. The exercise prescription will be individualized to each participant based on their pre-intervention fitness level, level of frailty and medical history. Progression of the program will be determined on an individual basis. All exercise programs will be designed and supervised by a clinical exercise physiologist. A hybrid approach will be used for the exercise sessions. The participant must attend the first exercise session in person and then can choose to attend subsequent sessions in person (Exercise Lab, Dickson Bldg) and/or virtually. All virtual sessions will be delivered via a secure Nova Scotia Health Zoom link. Having the first session in person gives all participants the opportunity to learn and discuss the exercises in a one-on-one format with the clinical exercise physiologist. After the first session it is expected that there may be multiple study participants in in-person or virtual exercise sessions. It is hypothesized that the addition of blueberries to a regimen of exercise plus protein will have synergistic beneficial effects on frailty and cardiovascular health in older individuals.
Our objectives are:
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Treatment groups will receive the STRONG intervention 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. They will also participate in three 60-minute multimodal exercise sessions per week. 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. The intervention lasts for 12 months.
Dietary Supplement: intervention of protein, blueberries · Behavioral: Exercise training
Participants receive usual standard of care.
Intervention 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.
Three 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.
Cardiovascular Risk - Echocardiography
Ejection fraction will be measured in M-mode and global longitudinal strain will be assessed.
Time frame: Baseline, 12 Months
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.
Time frame: Baseline, 12 Months
Frailty
Frailty will be assessed using a Frailty Index. The frailty index will be constructed based on deficit accumulation using established techniques
Time frame: Baseline, 3,6,9, and 12 months
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.
Time frame: Baseline, 3, 6, 9, 12 months
Cardiovascualr Risk: Lipid Profile
Blood will be drawn by venipuncture and then sent to the hospital lab. There the lipid profile will be determined. Specifically, total cholesterol (mmol/L), triglycerides (mmol/L), low density lipoprotein (mmol/L) and high density lipoprotein (mmol/L) will be quantified. In addition, blood values will be used to calculate Framingham and Reynold's risk scores.
Time frame: Baseline, 12 months
Frailty: Clinical Frailty Scale (CFS)
Frailty will be assessed using the CFS. The scale for the assessment ranges from 0 to 9, where 0 represents a robust individual and 9 represents terminally ill. A score of 4 or higher indicates frailty. This is a clinical judgement tool.
Time frame: Baseline, 3, 6, 9, 12 months
Frailty: Pictorial Fit to frail Scale (PFFS)
Frailty will be assessed with the PFFS. The PFFS is completed by the participant and uses visual images to assess their level of fitness/frailty. There are 14 sets of images on the PFFS. Each set contains 3-4 images and the participant is asked to pick the images that represents how they "usually" feel. The questionnaire is scored out of 43, with higher scores representing a higher degree of frailty.
Time frame: Baseline, 3, 6, 9, 12 months
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.
Time frame: Baseline, 3,6,9, and 12 months
Functional Fitness
Assessed using a 6-minute walk test (6MWT). Total distance in meters will be recorded.
Time frame: Baseline, 3,6,9, and 12 months
Balance
Single leg balance test. Total time in seconds will be recorded.
Time frame: Baseline, 3,6,9, and 12 months
Mobility: Lower Body
Lower body mobility will be assessed using the sit \& reach test. Reach distance will be measured in centimeters.
Time frame: Baseline, 3,6,9, and 12 months
Overall Health
Overall health status will be assessed using the Short-Form 36 Health Survey (SF-36) . The SF-36 contains 10 items. The scores range from 0 to 100, with lower scores representing more disability and higher scores representing less disability.
Time frame: Baseline, 3,6,9, and 12 months
Muscular Health: Upper Body
Upper body strength will be assessed using a hand grip dynamometer. Grip strength will be measured in kg.
Time frame: Baseline, 3, 6, 9, 12 months
Mobility: Upper Body
Upper body mobility using the shoulder girdle mobility test. The range of motion will be measured in centimeters.
Time frame: Baseline, 3, 6, 9, and 12 months.
Household Foodwork Interactional Assessment 10 Questions (FIA-Q10)
Household foodwork is "all the tasks a household does for eating". This includes the physical parts of foodwork (such as shopping, chopping, cooking, and cleaning) and the mental parts (such as budgeting, monitoring how much food is at home and what is needed, and remembering food allergies and special diets).
Time frame: Baseline, 6-month, 12-month, 1 year
ASA24 Dietary Assessment Tool
Time frame: Baseline, 6-month, 12-month, 1-year.
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.
Time frame: Safety will be assessed at 1,3,6,9, and 12 months.
Study Adherence
Exercise attendance and blueberry/protein consumption will be monitored using an electronic participant logbook.
Time frame: On the last day of the month particpants will upload the months logbook. (e.g. On November 30th, participant would upload the November logbook). This will be done for every month the participant is in the study (i.e. 12 months).
Incident Outcomes Related to Frailty
Impaired balance, falls, hip fractures, changes in like-space, social engagement.
Time frame: Baseline, 3, 6, 9, 12 months
CVD
Angina, heart attack, stroke.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jun 2028, 30 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 30 months is above that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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