Home-Based Physical Activity Measures for Cardiovascular Disease

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Under 18

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to track physical activity and fitness from home for people with a low risk of heart disease. Participants will use handheld devices to record daily exercise, assess their neighborhood environment, and track fitness levels. The trial aims to compare the effectiveness of these home-based methods with traditional ones. It suits English-speaking individuals under 45 if male, or under 55 if female, without a cancer history and with fewer than two heart disease risk factors. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance home-based fitness tracking for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these home-based data collection methods are safe?

Research has shown that tracking physical activity and environmental data is safe. Studies have found that being active lowers the risk of heart disease, making the recording of physical activity generally low risk.

Checking local gyms or parks is also safe and helps researchers understand how surroundings affect heart health. No evidence suggests that collecting this data causes harm.

Both methods in the study use hand-held devices to gather information. These devices are non-invasive and do not physically affect the body.

In summary, tracking physical activity and assessing environments are safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to track and improve physical activity for those with cardiovascular disease. Unlike traditional interventions that might focus on medication or in-person therapy, this trial uses hand-held computers to gather real-time data on physical activity and environmental factors right from participants' homes. This approach could lead to more personalized and flexible activity plans, potentially increasing adherence and effectiveness. By using technology to assess both physical activity and environmental conditions, the trial aims to uncover how surroundings impact heart health, offering insights that could shape future treatment strategies.

What evidence suggests that this trial's methods could be effective for measuring physical activity and environmental factors related to cardiovascular disease?

This trial will compare two approaches to understanding how physical activity and environmental factors affect cardiovascular health. Research has shown that regular physical activity greatly improves heart health. Studies have found that exercising for 30-40 minutes, 3-5 times a week, lowers blood pressure and resting heart rate. It can also slow the progression of heart disease and improve long-term health. Where a person lives can also affect heart health. Access to parks and gyms, along with feeling safe in one's neighborhood, can influence heart health risks. Together, these factors help reduce the chances of developing heart problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults under 45 (men) or under 55 (women), with low risk for cardiovascular disease, meaning they have less than two risk factors and no history of cancer. Pregnant women and children under 18 cannot participate.

Inclusion Criteria

I have never been diagnosed with cancer before.

I am under 45 (if male) or under 55 (if female) with less than two heart disease risk factors.

Able to give informed consent

Exclusion Criteria

I am under 18 years old.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 phone call

Baseline Assessment

Participants complete initial assessments including height, weight, and a treadmill test at the research center

1 day

1 visit (in-person)

Home-Based Data Collection

Participants use handheld devices to record physical activity and environmental assessments, wear pedometers and actigraphs, and perform home fitness tests

1 week

Daily self-assessments

Follow-up Assessment

Participants return to the research center for final assessments including a stool-stepping test and waist/hip measurements

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Environmental Assessments
• Physical Activity Recall

Trial Overview The study tests home-based methods to measure physical activity using pedometers and real-time assessments, cardiorespiratory fitness through a step test, body measurements like waist circumference, and environmental factors affecting exercise habits.

How Is the Trial Designed?

Group I: Physical Activity Recall Active Control 1 Intervention

Hand-held computers will be used to record information for 7 days about physical activity. Assessments will be completed either 3 times a day or once a day.

Group II: Environmental Assessment Active Control 1 Intervention

Environmental assessments on a palm pilot either 3 times a day or once a day. Hand-held computer programs will be used to collect information about the community. Some factors will be assessed only once (e.g., availability of facilities) while other information will be collected over the course of 7 days (e.g., perceptions of neighborhood safety).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

Consumer activity trackers, which monitor physical activity metrics like steps and energy expenditure, have become increasingly popular and may aid users in achieving their physical activity goals.

Current evidence on the accuracy of these devices is limited, but they show potential for use in managing cardiovascular disease, suggesting a need for further research to evaluate their effectiveness in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Consumer Physical Activity Trackers as an Intervention Tool in Cardiovascular Disease Prevention and Treatment. Hickey, AM., Freedson, PS.[2018]

Wearable physical activity monitoring devices significantly increase daily walking activity in patients with cardiovascular disease (CVD), with a notable effect size of 0.85 based on a systematic review of 16 randomized controlled trials.

The most substantial improvements in daily steps were observed in interventions lasting less than 3 months, suggesting that shorter-term use of these devices may be more effective for enhancing physical activity in CVD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of wearable device-based interventions with feedback for increasing daily walking activity and physical capacities in cardiovascular patients: a systematic review and meta-analysis of randomised controlled trials. Heizmann, AN., Chapelle, C., Laporte, S., et al.[2023]

This review aims to evaluate how effective activity-monitoring devices and mobile applications are in improving physical activity and health outcomes for patients with cardiovascular disease undergoing cardiac rehabilitation, highlighting their potential role in supporting long-term exercise habits.

The review will analyze systematic reviews and meta-analyses of randomized controlled trials, ensuring a comprehensive assessment of the impact of these technologies on patient outcomes, with a focus on varying effectiveness based on patient characteristics and rehabilitation stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. Dafny, HA., Champion, S., Gebremichael, LG., et al.[2023]

A 6-week pedometer-based telephone intervention significantly increased physical activity levels in 215 cardiac patients who did not attend a cardiac rehabilitation program, with improvements in total activity time and walking sessions observed at both 6 weeks and 6 months.

This intervention could serve as an effective and accessible alternative for enhancing physical activity in cardiac patients post-hospitalization, potentially leading to major health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation. Furber, S., Butler, L., Phongsavan, P., et al.[2022]

A home-based cardiac rehabilitation program significantly improved cardiovascular function in low-risk patients, with the home group showing increased peak VO2 and exercise capacity after three months, while the control group experienced a decline.

The program was not only effective but also cost-efficient, averaging $502.71 per patient, and achieved 100% adherence, indicating high patient engagement and potential for widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much do the benefits cost? Effects of a home-based training programme on cardiovascular fitness, quality of life, programme cost and adherence for patients with coronary disease. Salvetti, XM., Oliveira, JA., Servantes, DM., et al.[2008]

Citations

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Environmental Impacts on Cardiovascular Health and ... We summarize how these environmental exposures affect cardiovascular health and highlight associated mechanisms and epidemiological outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5777598/

Environmental Determinants of Cardiovascular Disease - PMC Many features of the environment have been found to exert an important influence on cardiovascular disease (CVD) risk, progression, and severity.

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comprehensive review/expert statement on environmental risk ... The exposome framework offers a comprehensive approach to integrating lifelong environmental exposures into cardiovascular risk assessment and prevention. ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666667725000364

Composite socio-environmental risk score for ... The SE-MACE risk score effectively incorporates socio-environmental factors into cardiovascular risk assessment, identifying individuals at higher risk for ...

5. jacc.org jacc.org/doi/10.1016/j.jacadv.2023.100805

Environmental Pollution and Cardiovascular Disease This article is part 1 of a 2-part state-of-the-art review and discusses air pollution and its adverse effects on CVD.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0048969725012379

The built environment and adverse cardiovascular events ... In this cohort study of 770,990 U.S. veterans, seven built environment features were significantly associated with an increased risk of MACE ...