62 Participants Needed

Home-Based Physical Activity Measures for Cardiovascular Disease

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The specific aim of this study is to collect preliminary data on the feasibility and validity of home-based data collection methods to measure four constructs:* Physical Activity: Real-time assessment using Ecological Momentary Assessment (EMA) and pedometers* Cardiorespiratory Fitness: Step test* Anthropometry: Waist and hip circumference measurements* Environmental Variables: Examples include density of neighborhood physical activity facilities (including gyms, parks, walking trails), crime, land use mix, and transportation variables, collected by participants using EMA.

Will I have to stop taking my current medications?

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

Is home-based physical activity safe for elderly adults with chronic illnesses?

A study on elderly adults with chronic illnesses participating in a home-based exercise program found that it was generally safe when delivered by an exercise therapist after medical clearance from a general practitioner.12345

How is the home-based physical activity treatment for cardiovascular disease different from other treatments?

This treatment is unique because it focuses on home-based physical activity, which can be more accessible and convenient for patients compared to traditional clinical settings. It emphasizes self-reported and objective measures of physical activity, potentially offering a personalized approach to managing cardiovascular disease.678910

What data supports the effectiveness of the treatment Environmental Assessments, Physical Activity Recall for cardiovascular disease?

Research shows that using wearable devices to monitor physical activity can help increase daily walking and improve physical health in people with cardiovascular disease. Additionally, home-based programs that encourage physical activity have been found to enhance cardiovascular fitness and quality of life for patients with heart conditions.1112131415

Who Is on the Research Team?

Karen M. Basen-Engquist | MD Anderson ...

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
See 1 more

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?
2Treatment groups
Active Control
Group I: Physical Activity RecallActive Control1 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 AssessmentActive Control1 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).

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

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. [2023]
Demographic and clinical determinants of moderate to vigorous physical activity during home-based cardiac rehabilitation: the home-based determinants of exercise (HOME) study. [2016]
Effectiveness of activity-monitoring devices in patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol. [2023]
Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation. [2022]
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. [2008]
Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]
Modeling errors in physical activity recall data. [2022]
Comparing the 7-day physical activity recall with a triaxial accelerometer for measuring time in exercise. [2022]
A prospective study of the reliability and convergent validity of three physical activity measures in a field research trial. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Utility of Consumer Physical Activity Trackers as an Intervention Tool in Cardiovascular Disease Prevention and Treatment. [2018]
Frequently reported activities by intensity for U.S. adults: the American Time Use Survey. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Reliability and validity of a modified self-administered version of the Active Australia physical activity survey in a sample of mid-age women. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
The validity of the Stanford Seven-Day Physical Activity Recall in young adults. [2019]
Development and Evaluation of an Accelerometer-Based Protocol for Measuring Physical Activity Levels in Cancer Survivors: Development and Usability Study. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Validation of the physical activity instrument for the Life in New Zealand national survey. [2019]
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