mHealth for Exercise Training

(MOTAFIT Trial)

Overseen By Kate Sansum, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Congenital cardiac, Respiratory, Metabolic, others

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

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The researchers are investigating whether adding mobile technology to a home-based exercise counselling program makes it easier for youth to begin and maintain regular exercise. Participants who joins the study will receive exercise counselling from an exercise specialist, but half of all participants will receive mobile technology - a fitness watch - that links to a mobile phone App. The mobile App allows the exercise specialist to provide personalized feedback throughout the program via the fitness watch. The investigators are interested to know whether the fitness watch and mobile App will make it easier for youth to achieve their exercise goals. Both groups will be compared to an active control group, who will receive no exercise program.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment mHealth for Exercise Training?

Research shows that using mobile applications for exercise programs can help patients better integrate exercises into their daily lives and improve adherence compared to traditional methods. Additionally, a study found that a smartphone app with an accelerometer may increase physical activity in hospitalized patients, suggesting potential benefits for exercise training. ^{1 2 3 4 5}

Is mHealth for Exercise Training generally safe for humans?

Research on exercise therapy, including mHealth, suggests that while there are benefits, there can also be risks of adverse events (unwanted side effects). It's important for participants to be aware of these risks and for researchers to report them clearly, especially for high-risk groups like the elderly or those with chronic conditions. ^{6 7 8 9 10}

How does the mHealth treatment for exercise training differ from other treatments?

The mHealth treatment for exercise training is unique because it uses a smartphone app to monitor and provide real-time feedback on exercise form, helping users correct their movements and improve performance. This approach is different from traditional methods that rely on visual assessment by clinicians, as it offers precise, continuous monitoring and can enhance exercise adherence by integrating evidence-based strategies. ^{1 11 12 13 14}

Research Team

Alison McManus, PhD

Principal Investigator

University of British Columbia- Okanagan

Eligibility Criteria

This trial is for young people who want to start and keep up a regular exercise routine. Participants will get advice on exercising from a specialist. However, they can't join if certain conditions prevent them from safely engaging in physical activity.

Inclusion Criteria

I am between 13 and 16 years old.

Be comfortable communicating in English

I am either male or female.

Exclusion Criteria

Have a known metabolic disease (e.g., Type 1 diabetes)

Are pregnant

Not owning a smartphone/ or having no data plan or access to Wi-Fi

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Participants complete pre-randomisation baseline testing

1 week

1 visit (in-person)

Treatment

Participants undergo a 3-month structured exercise and PA intervention, supported by an exercise specialist, with or without mHealth technology

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for adherence and effectiveness of the exercise intervention

6 months

3 visits (in-person)

Treatment Details

Interventions

• mHealth

Trial Overview The study is testing if using mobile technology, like a fitness watch linked to an app, helps youth follow through with their exercise plans better than just getting counseling alone. Half the participants will use the tech while the other half won't.

Participant Groups

Group I: mHealth Experimental Treatment 1 Intervention

Participants will undertake a 3-month structured exercise and PA intervention, supported by an exercise specialist. Participants will have 5 exercise consultations. Participants will receive a personalised progressive exercise programme. The aim will be to increase exercise intensity and duration during the first 3-months; aiming to meet the aerobic training guidelines of 3-4 sessions of at least 40 minutes at 85-90% heart rate maximum or of vigorous intensity. During follow-up, the aim will be to at least maintain this level of exercise. Participants will receive 1) a wrist worn fitness watch (Polar Ignite), featuring a 3d accelerometer and optical heart rate monitor, and 2) a smartphone app for participants (Polar Flow - Sync \& Analyse). These will be synced, allowing data to be transferred to the exercise specialist, who will created monitor pre-set exercise sessions.

Group II: Active control Active Control 1 Intervention

Participants will receive no exercise or PA intervention. Participants will continue with regular PA behaviours as an active control comparator. Participants in the control group will be monitored at the start and the end of the 3 months intervention period (2 weeks) to determine habitual PA and exercise levels

Group III: Exercise Counselling Active Control 1 Intervention

Participants will undertake the same 3-month structured exercise and PA intervention, supported by an exercise specialist, but without the use of mHealth technology to support the prescription and adherence to the exercise. Participants will be monitored using a wrist worn fitness watch, but will not receive feedback or have pre-set exercise sessions through the mHealth technology

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

MOSS ROCK PARK FOUNDATION

Collaborator

Trials

1

Recruited

120+

Findings from Research

A novel smartphone app for exercise training demonstrated high accuracy and precision in measuring movement, with mean differences of less than 1°/s compared to a gold standard dynamometer across various speeds.

The app's performance was validated with a coefficient of variation under 3% for most velocities, indicating it can reliably track exercise movements, making it a promising tool for clinicians to monitor patient performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and Precision of an Accelerometer-Based Smartphone App Designed to Monitor and Record Angular Movement over Time. Bittel, AJ., Elazzazi, A., Bittel, DC.[2017]

A study involving 78 hospitalized patients showed that using the Hospital Fit app alongside usual physiotherapy led to a trend of increased physical activity, particularly in standing and walking, although the results were not statistically significant.

Patients who used the app for longer periods experienced greater increases in physical activity, suggesting that the app may be beneficial for functionally independent patients in promoting movement during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Smartphone App with an Accelerometer on the Physical Activity Behavior of Hospitalized Patients: A Randomized Controlled Trial. Dijk-Huisman, HCV., Senden, R., Smeets, MHH., et al.[2023]

A mobile video-guided home exercise program significantly improved exercise adherence (75.6% vs. 55.2%) and self-efficacy for exercise compared to a standard paper-based program in stroke recovery patients over three months.

Participants using the video-guided program also showed greater improvements in mobility levels (MFAC gain of 1.7 vs. 1.0) but did not demonstrate significant differences in basic activities of daily living (ADL) compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial. Chung, BPH., Chiang, WKH., Lau, H., et al.[2022]

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]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., 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]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

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]

References

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

Accuracy and Precision of an Accelerometer-Based Smartphone App Designed to Monitor and Record Angular Movement over Time. [2017]

2. Canada pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on and Experiences of Home Exercise Programmes Delivered with a Mobile Application. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of a Smartphone App with an Accelerometer on the Physical Activity Behavior of Hospitalized Patients: A Randomized Controlled Trial. [2023]

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

Prospective, Single-blind, Randomized Controlled Trial to Evaluate the Effectiveness of a Digital Exercise Therapy Application Compared With Conventional Physical Therapy for the Treatment of Nonoperative Knee Conditions. [2022]

5. Singapore pubmed.ncbi.nlm.nih.gov

Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

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 Theory-Based Exercise App to Enhance Exercise Adherence: A Pilot Study. [2022]

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

Improving Exercise Performance with an Accelerometer-Based Smartphone App: A Randomized Controlled Trial. [2017]

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

A smartphone approach for the 2 and 6-minute walk test. [2020]

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

Using Mobile Health (mHealth) Technology in the Management of Diabetes Mellitus, Physical Inactivity, and Smoking. [2018]