Mobility Promotion for Cardiovascular Disease

Overseen By Shirko Ahmadi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Other trials, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Mobility promotion for cardiovascular disease?

Research shows that cardiac rehabilitation, which includes mobility promotion, significantly benefits patients with cardiovascular disease by improving physical capacity, quality of life, and reducing the risk of future heart events. ^{1 2 3 4 5}

Is mobility promotion generally safe for humans?

Research on physical activity interventions, including mobility promotion, shows that while minor injuries like muscle strains can occur, serious adverse events are rare. Studies recommend starting with low intensity and gradually increasing to ensure safety. ^{6 7 8 9 10}

How does the mobility promotion treatment for cardiovascular disease differ from other treatments?

The mobility promotion treatment for cardiovascular disease is unique because it focuses on increasing physical activity as a way to improve heart health, rather than relying on medication. This approach emphasizes the benefits of simply moving more, which can lead to better health outcomes even with modest increases in activity. ^{11 12 13 14 15}

What is the purpose of this trial?

Frailty describes the overall health of a person. Inpatients with cardiovascular problems have a higher risk for frailty - or the sick are more likely to get sicker - causing longer hospital stays, hospital readmission, and death. Females are particularly vulnerable to these problems, generally displaying higher frailty levels than males. In hospital, patients spend almost all their time in bed, and this lack of movement worsens cardiovascular and musculoskeletal health, sometimes lengthening patients' hospital stay and priming them for another cardiovascular event. Prolonged sedentary time may be more detrimental on frailty among females than males. The proposed pilot project will test if an in-hospital General Medicine mobilization program reduces frailty (measure of overall health) in male and female inpatients with cardiovascular disease. A Kinesiologist will provide daily check-ins and promote daily movement (e.g., standing more, resistance bands, physical activity promotion, etc.). The investigators expect both males and females will lower their frailty levels, but given their higher frailty levels in general and because females are typically less active than males, the investigators expect the intervention's effects to be greatest among females. Sixty patients (30 females) will be recruited. Patients with a major heart problem, projected to be in-hospital for at least 3-days, and can independently provide consent. Frailty will be measured using a validated questionnaire. Participants will also be equipped with activity monitors for 24h/d continuous wear to measure amount of time spent stepping, sitting, and lying. Hospital records will be used for length of stay and readmissions. The investigators will compare the outcomes (activity and frailty) between males and females to determine if the intervention impacted each sex differently. This work will guide improved care plans to decrease frailty and improve health outcomes in both male and female patients with heart problems.

Eligibility Criteria

This trial is for male and female inpatients with cardiovascular disease who are at risk of frailty. Participants must have a major heart problem, be expected to stay in the hospital for at least 3 days, and be able to give consent independently. The study aims to include 60 patients (30 females).

Inclusion Criteria

Patients who are admitted to unit 4C at the Vitalité Health Network

Patients who are projected to be in-hospital for at least 3 days

Patients who are not in a shared room with another study participant

Exclusion Criteria

Patients enrolled in other clinical trials or interventions that might confound the results of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a mobilization program with daily check-ins by a Kinesiologist to promote movement and reduce frailty

2 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mobility promotion

Trial Overview The trial tests a mobilization program led by a Kinesiologist involving daily movement activities like standing, using resistance bands, and promoting physical activity. It aims to reduce frailty levels among these patients, with an expectation that it may benefit females more due to their generally higher levels of frailty.

Participant Groups

Group I: Males Experimental Treatment 1 Intervention

A team of Kinesiologists visit the patients daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed).

Group II: Females Experimental Treatment 1 Intervention

A team of Kinesiologists visit the patients daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed).

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Vitalite Health Network

Collaborator

Trials

3

Recruited

130+

Findings from Research

Cardiac rehabilitation programs have been updated to include coronary risk factor reduction, which is crucial for patients with established cardiovascular disease to lower their risk of future heart attacks, strokes, and death.

These modernized rehabilitation programs have been shown to significantly improve health outcomes for both men and women with coronary heart disease, enhancing their long-term well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern cardiac rehabilitation: Integrating the best measures to reduce a second cardiac event. Armbruster, RA., Lim, MJ.[2021]

Cardiac rehabilitation has been proven to significantly improve health outcomes for patients with cardiovascular disease, yet less than 50% of eligible patients participate in these programs.

To increase participation, a collaborative approach involving multiple agencies and professionals is necessary, along with tailored programs that address individual patient needs to enhance adherence and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving wellbeing with cardiac rehabilitation. Edmunds, L.[2016]

Comprehensive risk factor interventions, including regular physical activity, significantly improve outcomes for patients with cardiovascular disease (CVD), enhancing physical work capacity and overall survival while reducing the need for invasive procedures.

These interventions are beneficial not only for patients with coronary artery disease (CAD) but also for those with other atherosclerotic conditions, as they share common risk factors and can lead to improved quality of life and reduced cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the risk of heart disease and stroke. Franklin, BA., Sanders, W.[2010]

A 12-week telemonitored exercise-based cardiac rehabilitation program significantly improved physical capacity, muscle endurance, muscle power, muscle strength, and health-related quality of life in 34 moderate-risk cardiac patients.

Participants experienced a 10% increase in peak oxygen uptake and notable improvements in muscle endurance (17%), power (7%), and strength (10%), along with a 19% enhancement in physical and 17% in mental health-related quality of life, although peak oxygen uptake did not show long-term improvement at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitored exercise-based cardiac rehabilitation improves physical capacity and health-related quality of life. Laustsen, S., Oestergaard, LG., van Tulder, M., et al.[2020]

In a study of 914 post-acute coronary syndrome patients, those who participated in less than 75% of a standard 12-week cardiac rehabilitation program experienced significantly higher rates of major adverse cardiac events (MACE), with an incidence of 11.3% compared to 3.8% for those who completed the program.

Patients with incomplete cardiac rehabilitation were also more likely to be persistent smokers, suggesting lifestyle factors may contribute to their higher risk of adverse cardiac events, highlighting the importance of full participation in rehabilitation for better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients who do not complete cardiac rehabilitation have an increased risk of cardiovascular events during long-term follow-up. Sunamura, M., Ter Hoeve, N., van den Berg-Emons, RJG., et al.[2020]

The EXPERT tool was developed to assist clinicians in prescribing exercise for patients with various cardiovascular diseases and risk factors, providing tailored recommendations based on specific conditions and individual patient factors.

This digital system offers exercise training recommendations and safety advice for 10 cardiovascular diseases and several chronic conditions, potentially improving the implementation of exercise rehabilitation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Association of Preventive Cardiology Exercise Prescription in Everyday Practice and Rehabilitative Training (EXPERT) tool: A digital training and decision support system for optimized exercise prescription in cardiovascular disease. Concept, definitions and construction methodology. Hansen, D., Dendale, P., Coninx, K., et al.[2018]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

This study aims to evaluate how patient education interventions can enhance physical activity (PA) capacity and behavior in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC), which are conditions that limit physical activity.

The review will analyze both quantitative and qualitative data from various databases, focusing on changes in PA capacity and adherence to PA improvements, using rigorous methods to ensure the quality and reliability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. Abaraogu, UO., Dall, PM., Seenan, CA.[2022]

Walking is associated with a reduced risk of developing cardiovascular disease (CVD), with stronger effects observed for ischaemic stroke compared to other CVD types, based on a systematic review of 21 studies.

Higher walking duration, distance, energy expenditure, and pace lead to greater reductions in CVD risk, supporting current physical activity recommendations, although potential biases from pre-existing health conditions need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking for prevention of cardiovascular disease in men and women: a systematic review of observational studies. Boone-Heinonen, J., Evenson, KR., Taber, DR., et al.[2021]

Research over the past 70 years shows that increased physical activity significantly reduces the risk of cardiovascular disease (CVD) and overall mortality, yet many people still do not engage in enough physical activity.

Even small increases in physical movement, such as transitioning from a sedentary lifestyle to a moderately active one, can lead to substantial health benefits, independent of overall cardiorespiratory fitness levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of moving more, physical activity, and cardiorespiratory fitness: Why we should strive to measure and improve fitness. Myers, J., Kokkinos, P., Arena, R., et al.[2021]

The 'Movement as Medicine for CVD Prevention' program showed promise in increasing physical activity levels among patients at risk for cardiovascular disease, with a significant increase in objective moderate to vigorous physical activity after 3 months (Cohen d=0.77).

Health care professionals who completed the web-based training reported improved self-efficacy and planning skills for promoting physical activity, indicating that the intervention may enhance their ability to support patients in making lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement as Medicine for Cardiovascular Disease Prevention: Pilot Feasibility Study of a Physical Activity Promotion Intervention for At-Risk Patients in Primary Care. Knittle, K., Charman, SJ., O'Connell, S., et al.[2022]

A systematic review of 19 smartphone app interventions for people with cardiovascular disease identified 40 different behaviour change techniques, with habit reversal and self-monitoring being the most common for sedentary behaviour and physical activity, respectively.

Action planning and graded tasks showed medium positive associations with increased physical activity, suggesting these techniques could be effective in future app designs aimed at improving physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change techniques in cardiovascular disease smartphone apps to improve physical activity and sedentary behaviour: Systematic review and meta-regression. Patterson, K., Davey, R., Keegan, R., et al.[2022]

A meta-analysis of 79 studies involving 11,877 participants found that interventions to increase physical activity (PA) in adults with cardiovascular disease resulted in a significant effect size of 0.35, indicating that treatment groups burned more calories (1984 kcal/week) compared to control groups (1615 kcal/week).

The analysis revealed that interventions focusing solely on physical activity, providing more contact with interventionists, and including supervised exercise sessions led to larger improvements in physical activity levels, suggesting that these factors enhance the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of interventions to increase physical activity among cardiac subjects. Conn, VS., Hafdahl, AR., Moore, SM., et al.[2021]

A scoping review of 20 studies involving patients with various cardiovascular diseases (CVDs) found that physiotherapy-led health promotion (PLHP) primarily focuses on exercise and physical activity, which were included in 85% of the studies.

Most interventions were short-term, lasting less than 12 months, and were personalized to encourage adherence and promote health behavior changes, highlighting the need for further exploration of additional health promotion components like sleep and substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapy-Led Health Promotion Strategies for People with or at Risk of Cardiovascular Diseases: A Scoping Review. Ngeh, EN., Lowe, A., Garcia, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Modern cardiac rehabilitation: Integrating the best measures to reduce a second cardiac event. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Improving wellbeing with cardiac rehabilitation. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Reducing the risk of heart disease and stroke. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Telemonitored exercise-based cardiac rehabilitation improves physical capacity and health-related quality of life. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Patients who do not complete cardiac rehabilitation have an increased risk of cardiovascular events during long-term follow-up. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The European Association of Preventive Cardiology Exercise Prescription in Everyday Practice and Rehabilitative Training (EXPERT) tool: A digital training and decision support system for optimized exercise prescription in cardiovascular disease. Concept, definitions and construction methodology. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Walking for prevention of cardiovascular disease in men and women: a systematic review of observational studies. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The impact of moving more, physical activity, and cardiorespiratory fitness: Why we should strive to measure and improve fitness. [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

Movement as Medicine for Cardiovascular Disease Prevention: Pilot Feasibility Study of a Physical Activity Promotion Intervention for At-Risk Patients in Primary Care. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Behaviour change techniques in cardiovascular disease smartphone apps to improve physical activity and sedentary behaviour: Systematic review and meta-regression. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Meta-analysis of interventions to increase physical activity among cardiac subjects. [2021]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Physiotherapy-Led Health Promotion Strategies for People with or at Risk of Cardiovascular Diseases: A Scoping Review. [2023]