Cardiovascular DiseaseSTRONGNCT06693271
Investigating the Combined Effects of Protein, Blueberries, and Exercise on Cardiovascular Health and Frailty in Older Nova Scotians
A study testing intervention of protein, blueberries and Exercise training in people with Cardiovascular Disease and Frailty, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Disease, Frailty
- What is being tested?
- intervention of protein, blueberries and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Must be 65 years of age or above
- Must be willing to participate in a low to moderate exercise program
Who cannot join
- Medical and cognitive conditions that prevent participation in the intervention
- Allergies and or dislike of blueberries and/or protein powder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
QEII Health Sciences Centre, Dickson Building
Halifax, Nova Scotia, B3H 2Y9
Olivia Mercer, STRONG@nshealth.ca
Scott Grandy, PhD, 902-494-4303, grandy@dal.ca
About this study
Official title: The STudy on bluebeRries, prOteiN, and Exercise for improvinG Frailty and Cardiovascular Disease (STRONG)
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.
Read the detailed description
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:
- 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
- Conditions
- Cardiovascular Disease, Frailty
- Being tested
- intervention of protein, blueberries, Exercise training
- Keywords
- Cardiovascular Disease, Frailty, Blueberries, Exercise, Protein, Obesity, Hypertension, Hyperlipidemia, Sedentary Lifestyle, Older Adults
- Medical subject headings
- Cardiovascular Diseases, Frailty, Motor Activity, Obesity, Hypertension, Hyperlipidemias, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention of protein, blueberriesDietary 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. 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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention of protein, blueberries, and exercise | Active comparator | 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. Receives: Dietary Supplement: intervention of protein, blueberries; Behavioral: Exercise training |
| Control group | No intervention | Participants receive usual standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Risk - Echocardiography
Ejection fraction will be measured in M-mode and global longitudinal strain will be assessed.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 6, 9, 12 months
Secondary outcomes (9)
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.
Measured: Baseline, 3,6,9, and 12 months
Functional Fitness
Assessed using a 6-minute walk test (6MWT). Total distance in meters will be recorded.
Measured: Baseline, 3,6,9, and 12 months
Balance
Single leg balance test. Total time in seconds will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 6-month, 12-month, 1 year
ASA24 Dietary Assessment Tool
Measured: Baseline, 6-month, 12-month, 1-year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start15 Dec 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Scott Grandy, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693271
- Sponsor's protocol ID
- STRONG_2024-2027
- Acronym
- STRONG
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cahill LE, Grandy SA, Gottheil C, Mercer O, Wright D, Consmueller C, Wong H, Jeon I, Rockwood K, Howlett SE. Study on blueberries, protein and exercise for improving frailty and cardiovascular disease (STRONG): protocol for a parallel-group randomised controlled superiority trial in older Nova Scotians. BMJ Open. 2026 Sep 25;16(9):e114286. doi: 10.1136/bmjopen-2025-114286.
PubMed 42790922
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STudy on bluebeRries, prOteiN, and Exercise for improvinG Frailty and Cardiovascular Disease (STRONG)
- ClinicalTrials.gov ID
- NCT06693271
- Acronym / sponsor ID
- STRONG / STRONG_2024-2027
- Conditions
- Cardiovascular Disease, Frailty
- Keywords
- Cardiovascular Disease, Frailty, Blueberries, Exercise, Protein, Obesity, Hypertension, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention of protein, blueberries, and exercise | Active comparator | Dietary Supplement: intervention of protein, blueberries, Behavioral: Exercise trainingTreatment 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. |
| Control group | No intervention | –Participants receive usual standard of care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Must be 65 years of age or above
- Must be willing to participate in a low to moderate exercise program
Key exclusion criteria (2 listed)
- Medical and cognitive conditions that prevent participation in the intervention
- Allergies and or dislike of blueberries and/or protein powder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention of protein, blueberriesIntervention 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. | Dietary supplement | intervention of protein, blueberries, and exercise |
| Exercise trainingThree 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. | Behavioural | intervention of protein, blueberries, and exercise |
Primary outcome
Cardiovascular Risk - Echocardiography
Time frame: Baseline, 12 Months
Ejection fraction will be measured in M-mode and global longitudinal strain will be assessed.
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.
Frailty
Time frame: Baseline, 3,6,9, and 12 months
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
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.
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. In addition, blood values will be used to calculate Framingham and Reynold's risk scores.
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.
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.
9 secondary outcomes
Muscular Health: Lower Body Strength
Time frame: Baseline, 3,6,9, and 12 months
Functional Fitness
Time frame: Baseline, 3,6,9, and 12 months
Balance
Time frame: Baseline, 3,6,9, and 12 months
Mobility: Lower Body
Time frame: Baseline, 3,6,9, and 12 months
Overall Health
Time frame: Baseline, 3,6,9, and 12 months
Muscular Health: Upper Body
Time frame: Baseline, 3, 6, 9, 12 months
Mobility: Upper Body
Time frame: Baseline, 3, 6, 9, and 12 months.
Household Foodwork Interactional Assessment 10 Questions (FIA-Q10)
Time frame: Baseline, 6-month, 12-month, 1 year
ASA24 Dietary Assessment Tool
Time frame: Baseline, 6-month, 12-month, 1-year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Derived from this study: PubMed 42790922Cahill LE, Grandy SA, Gottheil C, Mercer O, Wright D, Consmueller C, Wong H, Jeon I, Rockwood K, Howlett SE. Study on blueberries, protein and exercise for improving frailty and cardiovascular disease (STRONG): protocol for a parallel-group randomised controlled superiority trial in older Nova Scotians. BMJ Open. 2026 Sep 25;16(9):e114286. doi: 10.1136/bmjopen-2025-114286.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention of protein, blueberries and Exercise training in people with Cardiovascular Disease and Frailty, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott A Grandy, PhD (902-494-4303, Scott.Grandy@Dal.Ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Risk - Echocardiography (time frame: Baseline, 12 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.