Modified Breath Test for Sedentary Lifestyle

(BTLP Trial)

Overseen By Hugo JW Fung, PhD (c)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: NSAIDs, Anticoagulants, Statins, others

Disqualifiers: Chronic disease, Cancer, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to refine a breath test that detects how the body processes protein during activities such as resting, exercising, and reducing physical activity. The goal is to better identify when someone might be at risk of losing muscle or body mass. Participants will either maintain normal activities and reduce steps at home (step-reduction) or engage in resistance exercises in person (also known as resistance training or strength training). This trial suits healthy young adults who are not obese, have regular menstrual cycles, and are not on medications affecting muscle protein. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could lead to better health monitoring tools.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that affect muscle protein synthesis, such as statins, lithium, and ADHD medications. Regular use of NSAIDs (except low-dose aspirin) and anticoagulants is also not allowed.

What prior data suggests that this breath test method is safe?

Research has shown that resistance exercise is safe and beneficial for most people. Studies have found it helps build muscle strength and improve overall health. It benefits the heart, regardless of whether someone has heart disease.

Resistance training ranks among the safest types of exercise. When done correctly, it typically doesn't cause injuries. Therefore, participants should find the exercises in this trial manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to understand and counteract the effects of a sedentary lifestyle. Unlike traditional interventions that often focus solely on increasing physical activity, this trial investigates the impact of habitual activity combined with step-reduction and resistance exercise. By examining metabolic changes in both at-home and in-person phases, the trial aims to uncover the unique metabolic responses to different types of physical activity. This approach could reveal new insights into how varying activity patterns influence health, potentially leading to more personalized and effective lifestyle recommendations.

What evidence suggests that this trial's methods could be effective for detecting changes in protein processing?

Research shows that resistance exercise, which participants in the In-Person Phase of this trial will engage in, effectively maintains muscle health. Studies have found that regular resistance training can increase muscle mass by about 1.4 kg and raise the body's resting energy expenditure by 7%. It also helps reduce body fat by about 1.8 kg. Additionally, resistance exercise can prevent muscle loss and improve muscle function. These benefits are crucial for maintaining muscle strength, especially as individuals age or become less active. ^{3 4 6 7 8}

Who Is on the Research Team?

Ines Kortebi, MSc

Principal Investigator

University of Toronto

Daniel R Moore, PhD

Principal Investigator

University of Toronto

Hugo JW Fung, PhD (c)

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for people who live a sedentary lifestyle or are interested in how their body processes proteins during different activity levels, like resting, less movement, or resistance exercise. Participants should not have allergies that affect the study and must be able to perform physical tasks as required.

Inclusion Criteria

BMI between 18.5-29.9 kg/m2

I have been using a single-phase birth control pill for at least 3 months.

I have regular menstrual cycles and haven't used birth control pills for 6 months.

Exclusion Criteria

I regularly use NSAIDs or blood thinners, but not low-dose aspirin.

I am not taking medication that affects muscle building, like Statins.

My cancer is currently in remission or has recently been in remission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

At-Home Phase

Participants undergo habitual activity and step-reduction metabolic trials at home

6 days

Daily self-monitoring

In-Person Phase

Participants engage in habitual activity and resistance exercise metabolic trials in a controlled laboratory setting

5 hours per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the trial phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Habitual Activity
• Resistance Exercise
• Step-Reduction

Trial Overview

The study is testing a modified breath test method to see how well it measures protein processing by the body under various conditions: normal daily activities, reduced steps (less walking and moving), and after resistance exercises like weight lifting.

How Is the Trial Designed?

Group I: At-Home Phase Active Control 2 Interventions

Habitual Activity + Step-Reduction Metabolic Trials

Group II: In-Person Phase Active Control 2 Interventions

Habitual Activity + Resistance Exercise Metabolic Trials

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Published Research Related to This Trial

In a study of 95 participants with chronic obstructive pulmonary disease (COPD), 41% responded positively to ground-based walking training (GBWT) based on endurance improvements, while 58% reported a moderate improvement in walking ability.

Responders to GBWT tended to have better lung function and lower pre-training exercise capacity, indicating that those with more severe limitations may benefit more from this type of training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

People With COPD Who Respond to Ground-Based Walking Training Are Characterized by Lower Pre-training Exercise Capacity and Better Lung Function and Have Greater Progression in Walking Training Distance. Ho, JP., Alison, JA., Ng, LWC., et al.[2020]

Modified step tests (MST1 and MST2) can effectively approximate cardiovascular and respiratory responses similar to standard exercise tests like bicycle ergometry, suggesting they could be a cost-effective alternative for assessing fitness levels.

The study found that while the modified tests showed some increases in physiological parameters, they plateaued after 3 minutes, indicating a need for further research with larger populations to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular and respiratory adjustments in normal volunteers during modified exercise tests in comparison to standard exercise tests. Balgos, A., Lua, L., Pascual, R.[2019]

The 3-minute chair rise test (3CRT) was evaluated in 40 COPD patients and showed highly reproducible physiological responses and symptoms, making it a reliable alternative to the traditional 6-minute walk test (6MWT).

Patients who could perform more than 50 rises in the 3CRT demonstrated no significant disability, suggesting that this simple test can effectively assess exercise capacity and symptoms in COPD patients during routine medical consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple semipaced 3-minute chair rise test for routine exercise tolerance testing in COPD. Aguilaniu, B., Roth, H., Gonzalez-Bermejo, J., et al.[2022]

In a review of 121 trials involving 6700 older adults, most adverse events related to progressive resistance strength training were musculoskeletal issues like muscle strains and joint pain, particularly in participants with pre-existing health conditions or those engaging in high-intensity training.

Adverse events were often underreported, highlighting the need for clearer definitions and consistent reporting in future studies to better inform practitioners about the risks and benefits of strength training in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. Liu, CJ., Latham, N.[2010]

Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.

Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]

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]

High-resistance inspiratory muscle strength training (IMST) significantly improved exercise tolerance in healthy adults aged 50-79, increasing treadmill exercise time by an average of 67 seconds after 6 weeks, while sham training showed no change.

IMST also led to positive changes in body composition, including a 4.8% reduction in trunk fat mass and a trend towards increased thorax lean mass, indicating potential benefits for physical health in midlife and older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. Craighead, DH., Freeberg, KA., Heinbockel, TC., et al.[2023]

Resistance training (RT) significantly reduces all-cause mortality and the incidence of cardiovascular disease while improving physical functioning in adults, based on an analysis of 11 systematic reviews involving over 382,000 participants.

Although adverse events were not consistently reported, serious adverse events related to RT were uncommon, suggesting that the benefits of resistance training outweigh the potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. El-Kotob, R., Ponzano, M., Chaput, JP., 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]

A randomized controlled trial involving 43 COPD patients found that sensory-motoric training (SMT) was as effective as conventional strength training (KT) in improving exercise capacity, as measured by the 5-Times Sit-to-stand test and the 6-Minute Walk Test.

Both SMT and KT led to significant improvements in quality of life measures (SGRQ, CAT) and anxiety/depression levels (HADS) within each group, indicating that both training methods are beneficial for COPD patients during pulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of a Senso-Motoric Intervention in COPD-Patients Participating in an Outpatient Pulmonary Rehabilitation Program: A Randomized Controlled Trial]. Spielmanns, M., Müller, K., Schott, N., et al.[2018]

In a study of 51 patients, the stair climbing test (SCT) showed that the time taken to complete the test was a reliable indicator of maximal oxygen uptake (VO2 max), with a strong correlation (r = 0.707) and high accuracy (86%).

The SCT variable 'power' was less effective in predicting VO2 max, while the variable 'work' was not significant, indicating that time is the best measure for assessing cardiovascular fitness in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of the stair climbing test using maximal oxygen uptake as the gold standard. Cataneo, DC., Cataneo, AJ.[2022]

A 7-week program of supervised resistance training and light walking significantly reduced the apnea-hypopnea index (AHI) in institutionalized older adults, indicating an improvement in the severity of obstructive sleep apnea.

The study involved older adults in nursing and assisted living facilities, and while strength gains were observed, they did not correlate with the improvements in AHI, suggesting that the exercise regimen itself was key to the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strength training and light physical activity reduces the apnea-hypopnea index in institutionalized older adults. Herrick, JE., Bliwise, DL., Puri, S., et al.[2021]

In a study involving 20 elderly pulmonary rehabilitation patients over 8 weeks, those who underwent rapid progression in single-set resistance training showed significantly greater improvements in upper body strength and functional fitness compared to those with delayed progression.

Specifically, rapid progression led to notable enhancements in chest press strength and performance on functional fitness tests, indicating that increasing training intensity more quickly can be more beneficial for elderly patients in pulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progression of Resistance Training Intensity among Older COPD Patients: A Comparison of 2 Resistance Training Studies. Alexander, JL., Benton, MJ.[2014]

Pulmonary rehabilitation (PR) programs can significantly improve exercise capacity in disabled patients with chronic respiratory diseases and peripheral muscle disorders, emphasizing the importance of individual exercise assessments.

Among various exercise tests, the 6-minute walking test and shuttle walking test are particularly effective for evaluating functional abilities and detecting changes in physical performance after PR, with endurance tests showing better sensitivity to change than incremental tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise capacity as a pulmonary rehabilitation outcome. Clini, EM., Crisafulli, E.[2022]

In a study of 48 COPD patients, combining physical activity (PA) behavioral modification interventions with pulmonary rehabilitation (PR) led to significant improvements in patients' experiences of PA, as measured by the C-PPAC instrument.

The PR + PA group showed clinically important enhancements in total C-PPAC scores, including improvements in the difficulty and amount of PA, indicating that behavioral strategies can effectively boost physical activity levels in patients with low baseline activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural modification interventions alongside pulmonary rehabilitation improve COPD patients' experiences of physical activity. Armstrong, M., Hume, E., McNeillie, L., et al.[2021]

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