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

Trial Summary

What is the purpose of this trial?

Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. The current study aims to refine our previous breath test method to be more effective at measuring changes in how the body processes protein in different situations, such as resting, reducing physical activity, and doing resistance exercise. We hypothesize that using a lower amount of dietary amino acids in our breath test will be effective at detecting lower amounts of amino acids used after exercise, and a greater amount with step reduction compared to normal activity levels

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 data supports the effectiveness of the treatment Habitual Activity, Resistance Exercise, Resistance Training, Strength Training, Step-Reduction for sedentary lifestyle?

Research shows that resistance training and light physical activity, like walking, can improve physical function and reduce health issues in older adults. Additionally, strength training has been found to increase exercise tolerance and improve fitness in midlife and older adults. ^{1 2 3 4 5}

Is resistance training safe for humans?

Resistance training is generally safe for humans, with few serious adverse events reported. Most issues are minor, like muscle soreness or minor injuries, and can be minimized by starting slowly and gradually increasing intensity. ^{6 7 8 9 10}

How does the Modified Breath Test for Sedentary Lifestyle differ from other treatments for sedentary lifestyle?

The Modified Breath Test for Sedentary Lifestyle is unique because it focuses on assessing and potentially improving exercise capacity through a breath test, which is not a standard approach for addressing sedentary behavior. Unlike traditional exercise tests that require physical activity, this method may offer a non-invasive way to evaluate and encourage lifestyle changes. ^{11 12 13 14 15}

Research Team

Hugo JW Fung, PhD (c)

Principal Investigator

University of Toronto

Daniel R Moore, PhD

Principal Investigator

University of Toronto

Ines Kortebi, MSc

Principal Investigator

University of Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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]

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]

References

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

Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. [2023]

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

Strength training and light physical activity reduces the apnea-hypopnea index in institutionalized older adults. [2021]

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

Behavioural modification interventions alongside pulmonary rehabilitation improve COPD patients' experiences of physical activity. [2021]

4. United States 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Progression of Resistance Training Intensity among Older COPD Patients: A Comparison of 2 Resistance Training Studies. [2014]

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

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

7. New Zealand 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. [2022]

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

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. [2021]

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

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

11. Germany 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]. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise capacity as a pulmonary rehabilitation outcome. [2022]

13. Brazil pubmed.ncbi.nlm.nih.gov

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

14. Australia pubmed.ncbi.nlm.nih.gov

Cardiovascular and respiratory adjustments in normal volunteers during modified exercise tests in comparison to standard exercise tests. [2019]

15. New Zealand pubmed.ncbi.nlm.nih.gov

A simple semipaced 3-minute chair rise test for routine exercise tolerance testing in COPD. [2022]