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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of an online platform called HAIL when combined with the Fit and Strong! exercise program for older adults in Black communities. The trial compares two groups: one using only the exercise program and the other using both the exercise program and the HAIL platform. It seeks participants over 55 who are not currently in an exercise routine but can travel to a local church for sessions. Participants will assist researchers in determining if the online platform facilitates staying active. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance community health and wellness.

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 prior data suggests that the HAIL Online Platform is safe for older adults in black communities?

Research shows that the Fit and Strong! Program, part of the HAIL Online Platform, has been thoroughly studied. Previous studies found that this exercise program reduces pain and stiffness and increases lower body strength. This indicates it is generally safe and well-tolerated by older adults.

The HAIL Online Platform is new and is being tested for the first time with the Fit and Strong! Program. Since it is early in the research process, specific safety data for the online platform is not yet available. However, as an online tool designed to support a program already known to be safe, it is unlikely to pose major safety risks.

In summary, while the safety of the HAIL Online Platform is still under evaluation, the exercise component of the program has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HAIL Online Platform combined with the Fit and Strong! Program because it uniquely blends digital accessibility with personalized exercise for older adults in black communities. Unlike standard exercise programs that may not incorporate technology, this approach provides ongoing support and engagement through an online platform, even after the initial 8-week program ends. This digital component encourages sustained physical activity, potentially leading to greater long-term health benefits. Additionally, by being accessible both in-person and remotely, it offers flexibility and convenience, making it more adaptable to participants’ schedules and preferences.

What evidence suggests that the HAIL Online Platform + Fit and Strong! Program could be effective for older adults in black communities?

Research has shown that online platforms can make exercise programs more accessible and motivating. This trial tests the HAIL Online Platform to enhance the Fit and Strong! program. Participants in one group will use both the HAIL Online Platform and the Fit and Strong! program, which has successfully increased activity among older adults. Another group will use only the Fit and Strong! program without the online platform. Studies suggest that combining digital tools with exercise routines can improve participation and outcomes. This approach is particularly promising for reaching communities where traditional exercise programs are less accessible. Early findings indicate that digital platforms can help people maintain exercise habits long-term, especially when paired with in-person support. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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Fit & Strong! Works - Here's the Evidence

Fit & Strong! has been tested through randomized controlled trials and has shown to improve lower extremity (LE) pain, stiffness function, strength, ...