HAIL Platform + Exercise Program for Physical Activity

(HAIL Trial)

Overseen By Sofia Montinola, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive impairment, Heart conditions, others

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

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! program for older adults in black communities.

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 HAIL Platform + Exercise Program for Physical Activity treatment?

Research shows that using wearable activity trackers can help improve physical activity and recovery in patients, and brief exercise counseling is effective in increasing physical activity and exercise training, which can bring significant health benefits. ^{1 2 3 4 5}

Is the HAIL Platform + Exercise Program safe for humans?

There is limited information on the safety of exercise programs like the HAIL Platform, but studies suggest that adverse events (unwanted side effects) can occur, especially in resistance training. It's important for researchers to improve how they report these events to help people make informed decisions about participating in such programs. ^{6 7 8 9 10}

How is the HAIL Online Platform + Exercise Program treatment different from other treatments for physical activity?

The HAIL Online Platform + Exercise Program is unique because it combines an online platform with a structured exercise program, potentially offering real-time feedback and guidance similar to the Formulift app, which uses wearable sensors to improve exercise technique. This approach may provide more personalized and effective support compared to traditional unsupervised exercise programs. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for individuals over 60 years old who can travel to participating churches or senior centers. It's aimed at those not currently engaged in regular physical activity of moderate to vigorous intensity for at least 100 minutes per week.

Inclusion Criteria

I am over 60 years old.

Participants are able to travel to one of the churches for the in-person F&S! exercise sessions

Participants cannot be currently participating in a regular PA program (i.e., at least 100 min per week of moderate to vigorous physical activities)

Exclusion Criteria

I understand the study procedures and can participate in the verbal consent process.

Participants who receive a score of 28 or higher on the Telephone Interview for Cognitive Status (TICS) during pre-screening

Participants must have a physician responsible for their medical care

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (phone)

Baseline

Participants complete e-Consent and baseline assessments

1 week

1 visit (virtual)

Treatment

Participants complete the 8-week F&S! exercise program, with or without access to the HAIL online platform

8 weeks

8 visits (in-person and remote)

Follow-up

Participants continue to use the HAIL online platform and are monitored for retention and acceptability

12 weeks

3 visits (virtual)

Treatment Details

Interventions

• Fit and Strong! Program
• HAIL Online Platform

Trial Overview The study compares the standard Fit and Strong! (F&S!) exercise program with a combination of F&S! and the Healthy Activities Improve Lives (HAIL) online platform, specifically designed for older adults in black communities.

Participant Groups

Group I: HAIL Online Platform + Fit and Strong! Program Experimental Treatment 2 Interventions

Participants (N=60) will be recruited from two racially diverse churches or senior centers (30 participants per church/center) to examine the efficacy of the HAIL Online platform + F\&S! program for older adults in black communities. Participants will complete the 8-week F\&S! exercise program (with access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then continue to use the HAIL online platform during the 3-mo follow-up.

Group II: Fit and Strong! Program Active Control 1 Intervention

Participants (N=60) will be recruited from two racially diverse churches or senior centers (30 participants per church/center) to examine the feasibility and acceptability of the HAIL Online platform. Participants will complete the 8-week F\&S! exercise program (without access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then complete the 3-mo follow-up.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Interventions using wearable activity trackers during hospitalization significantly increased overall physical activity levels and reduced sedentary behavior among 1911 participants across various medical conditions, showing a standardized mean difference of 0.35 for activity and a reduction of 35.46 minutes per day in sedentary time.

Patients using these trackers also experienced improvements in physical function, with a standardized mean difference of 0.27, indicating that these devices can enhance recovery during hospital stays, although they did not significantly affect pain, mental health, length of stay, or readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions Using Wearable Activity Trackers to Improve Patient Physical Activity and Other Outcomes in Adults Who Are Hospitalized: A Systematic Review and Meta-analysis. Szeto, K., Arnold, J., Singh, B., et al.[2023]

Brief exercise training (ET) counseling is shown to be an efficient and cost-effective method to increase physical activity (PA) among patients, leading to significant health benefits across various disease groups.

To fully integrate exercise as a vital part of healthcare, a fundamental shift is needed in how healthcare systems view and implement ET counseling, treating it with the same importance as pharmaceuticals and other medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity promotion in the health care system. Vuori, IM., Lavie, CJ., Blair, SN.[2022]

Interventions using activity trackers during and after inpatient care can significantly increase physical activity levels in patients, with a small positive effect size (SMD = 0.34) observed in 13 studies involving 1435 patients.

However, these increases in physical activity did not lead to significant improvements in physical functioning, indicating that while activity trackers can motivate patients to move more, they may not directly enhance overall physical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. de Leeuwerk, ME., Bor, P., van der Ploeg, HP., et al.[2022]

An 8-week Internet-based tailored exercise program significantly improved functional capacity, as measured by the 6-minute walk test, in breast cancer survivors compared to usual care, with effects maintained at a 6-month follow-up.

The exercise program also enhanced cognitive performance, evidenced by improved recall in cognitive tests, indicating that telehealth interventions can effectively support recovery in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. Galiano-Castillo, N., Arroyo-Morales, M., Lozano-Lozano, M., et al.[2019]

The SPRINT physical activity program significantly improved walking speed, balance, and functional mobility in hospitalized older patients, demonstrating its efficacy in enhancing functional capacities during hospitalization.

Patients participating in the SPRINT program had a much shorter length of stay in the hospital (5 days) compared to those who did not participate (36 days), suggesting that this unsupervised and pragmatic approach can effectively reduce hospitalization time and improve discharge outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Efficacy of Pragmatic Exercise Program (SPRINT) during Hospitalization in Older Adults on Health Care and Physical Performance: A Pilot Study. Peyrusqué, E., Buckinx, F., Bolduc, A., et al.[2021]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

The SmartVax SMS-based system effectively monitored adverse events following immunization (AEFI) in a diverse population of 276 participants in Switzerland, achieving a high response rate of 90.3%.

The study found that 29.8% of immunization visits reported at least one AEFI, with the Shingrix® vaccine showing the highest rate of reactions, indicating that SmartVax can be a reliable tool for real-time vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. Guedel, DS., Peters, IJ., Banderet, F., et al.[2021]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

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]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

The Formulift app, which uses an inertial measurement unit to track exercise movements, received a positive evaluation for usability and functionality, achieving a mean usability score of 79.2 out of 100 from 15 participants, including beginners and experienced gym-goers.

Participants reported that the app effectively counted repetitions, classified exercise techniques, and provided valuable feedback, which could enhance their workout safety and motivation, although some bugs and suggestions for improvement were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Sensor-Based Exercise Biofeedback System: Mixed Methods Evaluation of Formulift. O'Reilly, MA., Slevin, P., Ward, T., et al.[2019]

An online supervised exercise program significantly reduced fasting blood sugar and body mass index (BMI) in 70 older patients with Type 2 diabetes over a 6-week period.

While both supervised and unsupervised exercise groups showed improvements in psychological resilience and quality of life, the online supervised group demonstrated greater benefits, suggesting it may be a valuable treatment option for older adults unable to attend in-person rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an online-supervised exercise program in older people with diabetes on fasting blood sugar, psychological resilience and quality of life: A double blind randomised controlled trial. Terkes, N., Aksu, NT., Yamac, SU.[2023]

The AIMFIT trial will assess the effectiveness of two smartphone apps—one immersive and one non-immersive—on improving cardiorespiratory fitness in 51 young people aged 14-17 over an 8-week period, with the primary outcome being the time to complete a one-mile run/walk test.

This study aims to provide empirical evidence on the effectiveness of commercially available fitness apps, potentially offering a new tool to enhance physical activity and fitness among young people, especially as adherence to app use will be monitored in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial. Direito, A., Jiang, Y., Whittaker, R., et al.[2018]

A review of 11 studies on mobile games designed to increase physical activity found that while these games are generally accepted and feasible for users, there is a lack of strong clinical evidence supporting their effectiveness in changing daily activity behavior.

Most games relied on goal setting and incorporated elements like rewards and competition, but the theoretical foundations for their design were limited, indicating a need for more rigorous research to establish their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Daily Physical Activity by Means of Mobile Gaming: A Review of the State of the Art. Tabak, M., Dekker-van Weering, M., van Dijk, H., et al.[2017]

The 'VIDEA bewegt' smartphone app significantly increased physical activity levels in German adults over eight weeks, as measured by MET minutes per week and step counts, with 55 out of 97 participants completing the program.

Participants also experienced improvements in health-related quality of life and recovery self-efficacy, along with reductions in time spent sitting and body mass index, indicating the app's potential effectiveness in promoting a healthier lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-based smartphone app ('VIDEA bewegt') for physical activity support in German adults: a single-armed observational study. Fischer, T., Stumpf, P., Schwarz, PEH., et al.[2022]

References

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

Interventions Using Wearable Activity Trackers to Improve Patient Physical Activity and Other Outcomes in Adults Who Are Hospitalized: A Systematic Review and Meta-analysis. [2023]

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

Physical activity promotion in the health care system. [2022]

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

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. [2019]

5. France pubmed.ncbi.nlm.nih.gov

Potential Efficacy of Pragmatic Exercise Program (SPRINT) during Hospitalization in Older Adults on Health Care and Physical Performance: A Pilot Study. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. [2022]

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

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

10. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

A Wearable Sensor-Based Exercise Biofeedback System: Mixed Methods Evaluation of Formulift. [2019]

12. England pubmed.ncbi.nlm.nih.gov

The effect of an online-supervised exercise program in older people with diabetes on fasting blood sugar, psychological resilience and quality of life: A double blind randomised controlled trial. [2023]

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

Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial. [2018]

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

Promoting Daily Physical Activity by Means of Mobile Gaming: A Review of the State of the Art. [2017]

15. England pubmed.ncbi.nlm.nih.gov

Video-based smartphone app ('VIDEA bewegt') for physical activity support in German adults: a single-armed observational study. [2022]