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NCT Number: NCT06693271

Investigating the Combined Effects of Protein, Blueberries, and Exercise on Cardiovascular Health and Frailty in Older Nova Scotians

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.

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Key information

Conditions

Cardiovascular Disease Behavior Body Weight Cardiovascular Diseases Dyslipidemias Frailty Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII Health Sciences Centre, Dickson Building

Halifax, Nova Scotia, B3H 2Y9, Canada

Location status: Recruiting

Location contact

Olivia Mercer

CONTACT

[email protected]

Scott A Grandy, PhD

PRINCIPAL_INVESTIGATOR

Scott Grandy, PhD

CONTACT

[email protected]

902-494-4303

About this study

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). They will be given 'report cards' with their test results to monitor their health; the treatment group will receive the reports cards as well. 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:

  • To determine whether the STRONG intervention reduces frailty equally in both sexes.
  • To determine whether this intervention improves cardiovascular health in males and females.
  • To determine whether beneficial effects of this intervention are mediated, in part, by effects on markers of chronic inflammation and whether these effects are sex specific

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 65 years of age or above
  • Must be willing to participate in a low to moderate exercise program

Exclusion criteria

  • Medical and cognitive conditions that prevent participation in the intervention
  • Allergies and or dislike of blueberries and/or protein powder

Treatment and study plan

intervention of protein, blueberries

Dietary Supplement

intervention of 30g/day (1 scoop) of a colorless, tasteless whey protein isolate powder supplement and 1 cup (150 grams) of blueberries per day.

Exercise Training

Behavioral

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.

Primary outcomes

  1. Functional Fitness

    Time frame: Baseline, 3,6,9, and 12 months

    Assessed using a 6-minute walk test (6MWT). Total distance in meters will be recorded.

  2. Echocardiography

    Time frame: Baseline, 12 Months

    Ejection fraction will be measured in M-mode and global longitudinal strain will be assessed.

  3. Inflammatory Markers

    Time frame: Baseline, 12 Months

    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.

  4. Frailty

    Time frame: Baseline, 3,6,9, and 12 months

    Frailty will be assessed using the Clinical Frailty Scale (CFS), Pictorial Fir-Frail Scale (PFFS), and Frailty Index

  5. Cardiovascualr Risk: Blood pressure

    Time frame: Baseline, 3, 6, 9, 12 months

    Resting blood pressure (systolic/diastolic) will be assessed using an automated blood pressure cuff. Blood pressure will be measure in mm of Hg.

  6. Cardiovascualr Risk: Lipid Profile

    Time frame: Baseline, 12 months

    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.

  7. Cardiovascualr Risk: Blood glucose

    Time frame: Baseline, 12 months

    After fasting for 12 hours the participants blood will be drawn by venipuncture. Blood samples will be sent to the hospital lab and fasting glucose (mmol/L) will be assessed.

  8. Frailty: Clinical Frailty Scale (CFS)

    Time frame: Baseline, 3, 6, 9, 12 months

    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.

  9. Frailty: Pictorial Fit to frail Scale (PFFS)

    Time frame: Baseline, 3, 6, 9, 12 months

    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.

  10. Household Foodwork Interactional Assessment 10 Questions (FIA-Q10)

    Time frame: Baseline, 6-month, 12-month, 1 year

    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).

  11. ASA24 Dietary Assessment Tool

    Time frame: Baseline, 6-month, 12-month, 1-year.

Secondary outcomes

  1. Muscular Health: Lower Body Strength

    Time frame: Baseline, 3,6,9, and 12 months

    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.

  2. Balance

    Time frame: Baseline, 3,6,9, and 12 months

    Single leg balance test. Total time in seconds will be recorded.

  3. Mobility: Lower Body

    Time frame: Baseline, 3,6,9, and 12 months

    Lower body mobility will be assessed using the sit & reach test. Reach distance will be measured in centimeters.

  4. Overall Health

    Time frame: Baseline, 3,6,9, and 12 months

    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.

  5. Muscular Health: Upper Body

    Time frame: Baseline, 3, 6, 9, 12 months

    Upper body strength will be assessed using a hand grip dynamometer. Grip strength will be measured in kg.

  6. Mobility: Upper Body

    Time frame: Baseline, 3, 6, 9, and 12 months.

    Upper body mobility using the shoulder girdle mobility test. The range of motion will be measured in centimeters.

Other outcomes

  1. Safety Outcomes

    Time frame: Safety will be assessed at 1,3,6,9, and 12 months.

    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.

  2. Study Adherence

    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).

    Exercise attendance and blueberry/protein consumption will be monitored using an electronic participant logbook.

Study contacts

Contact information is provided by the study sponsor or research team.

Scott A Grandy, PhD

CONTACT

[email protected]

902-494-4303

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University

Registry information

Official study title

The STudy on bluebeRries, prOteiN, and Exercise for improvinG Frailty and Cardiovascular Disease (STRONG)

Acronym: STRONG

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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