Tele-exercise for Motor Skills Affected by Toxic Exposures

(TEMPO Trial)

Overseen By Alice S Ryan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe pulmonary disease, Uncontrolled hypertension, Active cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a tele-exercise program can help Veterans exposed to burn pits during military service improve their movement and quality of life. Participants will either join a 12-week remotely led exercise program or receive standard care through health education sessions. Veterans who spent at least six hours a day near burn pits during deployments and can use video calls for the study may be suitable candidates. The goal is to enhance physical abilities and help Veterans overcome challenges like difficulty with short-distance running. As an unphased trial, this study offers Veterans a unique opportunity to contribute to research that could improve their health and well-being.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that tele-exercise is safe for Veterans with burn pit exposure?

Research has shown that exercising with a coach over video calls, known as tele-exercise, is generally safe and well-received by participants. Studies have found that this type of exercise program can boost physical fitness without causing major problems.

For example, one study on remote exercise programs found no significant safety concerns, indicating that people can safely exercise from home. Another study noted that these programs can improve overall well-being and help reduce anxiety and PTSD symptoms without negative side effects.

Although detailed data on negative effects is limited, existing research supports the safety of tele-exercise. These findings suggest that joining such programs is a low-risk way to enhance health and physical ability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tele-exercise for improving motor skills affected by toxic exposures because it offers a convenient and accessible alternative to traditional in-person rehabilitation. Unlike standard care options, which typically involve health education and in-person therapy sessions, tele-exercise allows participants to engage in guided exercise routines remotely from home. This method combines aerobic and resistance training in a circuit format, which can enhance motivation and adherence to the program. By making rehabilitation more flexible and potentially more engaging, tele-exercise has the potential to improve outcomes for individuals who have experienced toxic exposures.

What evidence suggests that tele-exercise is effective for improving motor skills affected by toxic exposures?

Research has shown that exercising through online sessions can greatly improve physical fitness and functional ability. Studies have found that it helps with movement, staying active, and strengthening the legs. Online exercise also improves quality of life and reduces pain. These benefits are especially noticeable when exercises are done live with a coach. In this trial, participants will either engage in tele-exercise sessions or receive standard care through health education discussions. For veterans exposed to burn pits, the tele-exercise method could enhance their movement and overall well-being. ^{6 7 8 9 10}

Who Is on the Research Team?

Alice S. Ryan, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for Veterans aged 40 or older who were exposed to burn pits during military service overseas. They must have been exposed for at least 6 hours daily over a deployment of three months or more, be able to give written consent, and use video conferencing technology.

Inclusion Criteria

Veteran

I can use video calls for appointments.

I am 40 years old or older.

Exclusion Criteria

I am currently receiving treatment for my cancer.

Active severe mental health or psychiatric issues, including suicidality

I do not have any health issues that prevent me from joining a tele-exercise program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week tele-exercise intervention or receive standard of care

12 weeks

3 sessions per week (remote)

Follow-up

Participants are monitored for changes in physical function and fitness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tele-exercise

Trial Overview The study compares two approaches: standard care versus a tele-exercise program designed to improve functional mobility in Veterans with documented limitations from burn pit exposure. The tele-exercise will be led by a coach over 12 weeks.

How Is the Trial Designed?

Group I: Tele-exercise Active Control 1 Intervention

Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Group II: Standard of Care Placebo Group 1 Intervention

Health education discussions and lectures 2-3x/week led remotely.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775025/

The Effect of Web-Based Telerehabilitation Programs on ... Web-based telerehabilitation therapy improved motor function, physical activity level, lower limb strength, letter-number sequencing, attention, and symbol ...

2. jmir.org jmir.org/2023/1/e46957/PDF

The Effect of Web-Based Telerehabilitation Programs on ... Objective: This study evaluated the therapeutic effect of web-based telerehabilitation training on children and adolescents with brain injury ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11821610/

Impact of tele-exercise on quality of life, physical fitness ... The results indicate that tele-exercise, especially synchronous, has the potential to primarily improve physical fitness, functional capacity, and pain ...

4. mdpi.com mdpi.com/1648-9144/61/4/651

Effects of Telehealth-Supervised Respiratory Exercise ... Conclusions: Telerehabilitation incorporating respiratory exercises effectively enhances the respiratory function, fatigue, and quality of life of MS patients, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05235113

Remote Game-based Exercise Program for Cognitive and ... This study aims to develop and validate a remote exercise intervention for individuals at risk of or experiencing dementia using a wearable sensor-enabled ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12340145/

Safety of videoconferencing for physical rehabilitation and ... Investigate the safety of physical rehabilitation and/or exercise ... training', 'physical therapy' and 'physical activity'. Specific search ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07567-8

Effects of a remotely supervised physical training program ... Indeed, a reduction in the physical activity levels of older adults is strongly associated with increased cardiovascular risk, social isolation, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07018466

Study Details | NCT07018466 | Tele-Exercise for MERP Veterans with burn pit exposures will benefit from physical activity interventions designed to improve functional ability and overall quality of ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2093791124000763

Health Outcomes Related to Multiple Exposures in ... Seven activity sectors were identified: 'extraction and energy production and distribution', 'health care', 'banks, public administration and defence', ' ...

10. mdpi.com mdpi.com/2075-4663/11/5/102

The Effect of a Home-Based Tele-Exercise Training ... Engagement in physical activity programs has been suggested to improve overall functional ability and QoL and ameliorate anxiety and PTSD symptoms in cancer ...