Telehealth Exercise Program for Cardiometabolic Health

(CHIME Trial)

Overseen By Jereme Wilroy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Medically unstable, High-level tetraplegia, No internet, others

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

Compensation: Varies

Number of Visits: 17

Duration: 24 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve heart and metabolic health for adults who use wheelchairs. It compares a fun, music-based exercise program led by an instructor (Instructor-led, one-on-one exercise group) to regular exercise videos done independently (Self-guided control with virtual fitness membership). Researchers aim to determine if this approach can more effectively reduce waist size, blood pressure, and other health risks associated with heart and metabolic issues. Individuals who primarily use wheelchairs, have at least two health risk factors related to heart or metabolism, and do not exercise regularly may be suitable candidates. The trial will also assess whether health improvements persist after the program concludes. As an unphased trial, this study provides a unique opportunity to explore innovative exercise methods that could enhance health and well-being.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this exercise program is safe for cardiometabolic health?

Research has shown that the instructor-led, one-on-one Movement-to-Music exercise program is generally manageable for participants. Studies have found that these programs, which aim to improve heart and metabolic health, usually have manageable side effects. Most people can perform the exercises without serious issues. The combination of music and movement is designed to make the exercises enjoyable, potentially encouraging adherence to the program. Although specific safety details are not available, the absence of major negative reports suggests that the program is safe for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of a telehealth exercise program for improving cardiometabolic health. Unlike traditional exercise programs that require in-person attendance, this trial offers an instructor-led, one-on-one exercise experience remotely. This innovative approach provides personalized guidance while offering the convenience and accessibility of participating from home. Additionally, the trial includes a self-guided arm featuring pre-recorded exercise videos, allowing participants to engage at their own pace. This dual approach not only aims to enhance engagement and adherence but also seeks to determine the impact of different levels of interaction on health outcomes.

What evidence suggests that this trial's exercise programs could be effective for improving cardiometabolic health?

Research shows that exercising with music can improve heart and overall health. Studies have found that these programs can help shrink waistlines, lower certain fats in the blood, and increase "good" cholesterol. They can also help control blood sugar and blood pressure, which are important for heart health. In this trial, participants in Group 1 will receive instructor-led, one-on-one exercise sessions. Early results suggest this approach might be more effective than self-guided programs. This method uses music to make exercise more enjoyable and may lead to better long-term health benefits. Meanwhile, participants in Group 2 will follow a self-guided control program with pre-recorded standard exercise videos. ^{1 2 3 4 6}

Who Is on the Research Team?

Jereme Wilroy, PhD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Adult wheelchair users with at least two cardiometabolic risk factors, who can exercise using their arms and have not been in a structured exercise program recently. They must speak English, get less than 90 minutes of moderate exercise weekly, and have internet access. Those with high-level tetraplegia or medical instability for home exercises are excluded.

Inclusion Criteria

I can use my arms to exercise.

No contraindication to exercise as informed by the Physical Activity Readiness Questionnaire (PAR-Q) (any contraindication will be reviewed by the participant's physician as a secondary approval method)

I mainly use a wheelchair or electric scooter to get around.

Exclusion Criteria

I have severe paralysis and cannot use my arms for exercise.

Medically unstable to perform home exercise as determined by their physician

No internet access determined via self-report and internet speed test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments including physical tests and questionnaires

1 week

1 visit (in-person) and online questionnaires

Treatment

Participants engage in a 24-week exercise program, either instructor-led or self-guided

24 weeks

3 sessions per week (combination of in-person and virtual)

Follow-up

Participants are monitored for maintenance of health improvements post-treatment

12 weeks

Assessments at 12 and 24 weeks, additional surveys at 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Instructor-led, one-on-one exercise group
• Self-guided control with virtual fitness membership

Trial Overview

The trial is testing a 24-week live telehealth exercise training to improve heart health risks in wheelchair users. It compares self-guided workouts with virtual fitness memberships against instructor-led sessions. A follow-up phase checks if the online program helps maintain activity levels.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

Instructor-led, one-on-one M2M exercise group

Group II: Group 2 Active Control 1 Intervention

Self-guided control with pre-recorded standard exercise videos

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a pilot study of 77 overweight and obese adults, those who participated in a 3-month supervised exercise program showed significant improvements in fitness indicators, with 69% attending the gym at least 8 times per month.

However, adherence dropped significantly during the 9-month unsupervised phase, with only 8 out of 24 participants completing it, suggesting that ongoing supervision may be crucial for maintaining exercise habits, especially for individuals with joint symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an exercise program on adherence and fitness indicators. Carpenter, R., Gilleland, D.[2017]

In a study of 13,570 cardiac rehabilitation participants across 30 programs, there were 50 cardiac arrests during exercise, with a high resuscitation success rate of 84%, indicating that supervised exercise can be performed safely for selected cardiac patients.

The overall complication rates were low, with one nonfatal event occurring every 34,673 patient hours and one fatal event every 116,402 patient hours, suggesting that continuous ECG monitoring during exercise further enhances safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular complications during exercise training of cardiac patients. Haskell, WL.[2019]

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]

The home telehealth intervention, which included telephone counseling and video support, did not significantly impact weight maintenance among 88 obese or overweight African-American women after a weight loss program, with both groups showing minimal weight change.

Low usage of the digital video recorders (DVRs) suggests that the video content may not have been effectively utilized, indicating a potential barrier to the success of the telehealth intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. Gerber, BS., Schiffer, L., Brown, AA., et al.[2022]

The Best Exerciser Super Trainer program, designed for Korean male workers with metabolic syndrome, showed significant cardiovascular risk reduction after 8 weeks, including decreases in waist circumference, diastolic blood pressure, and fasting plasma glucose.

An expert evaluation indicated strong approval of the program's content, suggesting that the Internet-based approach effectively promotes lifestyle modifications tailored to individual readiness for physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and a pilot test of an internet-based cardiovascular risk reduction program for Korean male workers with metabolic syndrome. Kim, CJ., Kang, S.[2022]

A 12-week tele-exercise training program significantly improved physical activity levels and cardiorespiratory fitness in patients with cardiometabolic multimorbidity, with 68 out of 83 participants completing the study.

Participants in the tele-exercise group showed enhanced heart rate recovery and increased measures of fitness, such as VO2peak and workload, compared to those receiving usual care, indicating the program's effectiveness in managing cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a 12-week tele-exercise training program on cardiorespiratory fitness and heart rate recovery in patients with cardiometabolic multimorbidity. Chiang, SL., Shen, CL., Lee, MS., et al.[2023]

A 12-week home-based telehealth exercise training program significantly increased physical activity levels and exercise capacity in patients with cardiometabolic multimorbidity, as shown by a randomized controlled trial involving 50 participants.

The program also improved health-related quality of life, particularly in physical function, indicating that telehealth exercise interventions can be effective and beneficial for patients managing multiple cardiometabolic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial. Chiang, SL., Shen, CL., Chen, LC., et al.[2021]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

A telehealth exercise program is being tested for its feasibility and effectiveness in improving cardiorespiratory fitness among 80 older people with HIV, who are typically at risk for reduced fitness levels.

The program involves functional circuit training conducted via videoconferencing three times a week for 12 weeks, with heart rate monitoring to ensure participants maintain high exercise intensity, potentially addressing issues like sarcopenia and frailty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Exercise Intervention in Older Adults With HIV: Protocol of a Multisite Randomized Trial. Oursler, KK., Marconi, VC., Briggs, BC., et al.[2023]

Clinical video telehealth is an effective method for providing functional circuit exercise training to older veterans who live in remote areas, ensuring they have access to important physical activity.

This approach allows for personalized exercise programs to be delivered safely and effectively, improving the health and well-being of older veterans without the need for them to travel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Rural Veterans With Access to Exercise Through Gerofit. Briggs, BC., Jain, C., Morey, MC., et al.[2020]

In a study of 332 adults participating in a 14-week community exercise program, the prevalence of adverse cardiometabolic responses (ACR) was relatively low, with only 6.0% experiencing increased systolic blood pressure, 3.6% increased triglycerides, and 5.1% decreased HDL cholesterol after the program.

The findings suggest that personalized exercise programming can help reduce the risk of adverse cardiometabolic responses, supporting the idea of exercise as a preventative medicine approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of adverse cardiometabolic responses to exercise training with evidence-based practice is low. Dalleck, LC., Van Guilder, GP., Richardson, TB., et al.[2020]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

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