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HealthyNCT04357691

Effects of Different Cardiorespiratory Training Program on Endurance Performance

A study testing Conventional training and AI-led training in people with Healthy, run by Wang Yongtai Raymond at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Conventional training methods are typically administered in a fixed progressive manner, which can lead to sub-optimal responses and injuries. Artificial intelligence (i.e. CURATE.AI) can be harnessed to personalise physical training strategies. Read more about this study

Who is it for?
Ages 21 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Conventional training and AI-led training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSingapore
Study dates
25 May 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Do not smoke or use tobacco products (including shisha)
  • BMI < 30
  • Medically fit
  • 2.4 km run time of 10 to 14 minutes in the past 12 months

Who cannot join

  • •Individuals with a history of existing musculoskeletal injury or respiratory diseases

Trial locations and contacts

1 site in 1 country.

Yongtai, Raymond Wang, MSc contact

+65 90472892

phswyr@nus.edu.sg

Cherh Chiet, Ivan Low, PhD contact

+65 6516 7679

ivanlow@nuhs.edu.sg

Singapore1 site
  • National University of Singapore

    Singapore

    Yongtai, Raymond Wang, MSc, +65 90472892, phswyr@nus.edu.sg

Other trials in Singapore

About this study

Conventional training methods are typically administered in a fixed progressive manner, which can lead to sub-optimal responses and injuries. Artificial intelligence (i.e. CURATE.AI) can be harnessed to personalise physical training strategies. Using a single participant training profile, a parabolic/quadratic response to the intervention can be generated to identify the training intensity needed to optimise training outcomes. Previous studies showed CURATE.AI could dynamically modulate drug dosing in oncology. Extending the utility of results to human performance, this study will adapt CURATE.AI with the goal of optimising endurance performance through individualised training regimes.

Up to 20 participants will be recruited and randomised into two groups to undergo a calibration phase, which involves performing 3 sessions of exercise sessions per week over 2 weeks per intensity (low, moderate and high) in a crossover study design. Exercise sessions will be interspersed with a 2.4 km time trial, a VO2peak test and 2 weeks of wash out period. The utility phase will divide participants into two groups to undergo 3 exercise sessions per week, totalling to 12 exercise sessions. Either an AI-led training or a conventional training programme will be performed to compare the differences in training outcomes. Blood plasma will be obtained at selected time points in both phases to evaluate the effects of training on blood lipid profiles.

Findings from this study can potentially optimise efficacy and efficiency of endurance performance through personalised training with AI.

Read the detailed description

Participants:

Up to 20 recreationally active healthy males, aged between 21 to 35 years, will be recruited to take part in this study. All volunteers will provide their informed consent in writing before participating in the study. The possible risk and benefits will be made known to the participant prior to the agreement to participate and they will be allowed to withdraw from the study at any point in time without any reason provided. All potential participants will first be required to undergo medical screening by a certified independent practitioner before participating in the study. The medical practitioner conducting the assessment will be informed of the purpose of the medical screening. The screening is to ensure that the potential participant is eligible to take part in the study. The personal particulars form will also be completed by each participant prior to the commencement of each trial.

Baseline measurements and familiarisation trials:

In the first session, anthropometry measurements will be taken. Based on the height and nude body mass, the body mass index (BMI) will be calculated (body mass in kg) / (height in m)2. Waist and hip circumference will be determined using a measuring tape. Skinfold thickness measurements will be taken at 4 sites (biceps, triceps, subscapular and suprailiac) in triplicate using skinfold calliper and the mean value will be used to calculate total skin fold. Body density will be calculated according to the estimation of Durnin and Womersley (1974) and percentage body fat will be estimated using the equation of Siri (1956).

Familiarisation of the 2.4 km time trial and the treadmill peak oxygen uptake (VO2peak) test will be performed 2 weeks before the commencement of the actual 2.4 km time trial. Ample rest is given between the two sessions for recovery.

Control of trial status:

Before the commencement of every trials, participants will be reminded to remain hydrated by consuming sufficient fluids, to have at least 8 hours of sleep, to refrain from alcoholic beverages, and to refrain from any forms of strenuous physical activity 24 h before each trial. Blood glucose will be measured before the start of the session via finger pricked using a lancing device. Prior to the pricking of the finger, the site will be disinfected with an alcohol wipe(s) and pressure will be applied to the site of the prick after blood sampling to minimise any bruising that may develop. In addition, Participants will be required to perform a 2-day dietary record prior to every blood draw session. They will be requested to refrain from participating in other aerobic training regimes (other than the prescribed exercise routine) or any acute strenuous bout of exercise that is not part of their routine during the study period.

Study design:

Participants will be required to undergo endurance interval training with low, moderate or high intensity. Each training session will comprise a warm-up run (50-60% VO2peak) followed by a 1-min fast run (80 to 140% VO2peak) interspersed with 1-min of recovery between each running bout till participants reach 18 out of 20 on the ratings of perceived exertion (RPE; Borg's scale). Participants will perform 10-15 repetitions of interval runs during each session. Heart rate, RPE, and blood pressure will be measured continuously at stipulated intervals. Water will be provided ad libitum during all training sessions. In the utility phase, participants will either perform an AI-led training or a conventional training program for 4 weeks. A 2.4 km time trial and a treadmill peak oxygen uptake (VO2peak) test will be conducted at baseline, in between the low, moderate and high intensity bouts of training in the calibration phase, and before the first and last week of the utility phase. Similar to the familiarisation trials, the treadmill VO2peak test and 2.4 km time trial will be done at 3 days apart from each other to allow for recovery. The two phases would consist of 47 sessions, inclusive of seven VO2peak tests and seven 2.4 km time trials. The total duration for each participant will take approximately 6 months.

Blood sampling and analysis:

After 5 min of seated rest, participant will immerse their arm in warm water (42-45°C) for 10 min to promote arterialisation of venous blood. Blood (10 ml) will be withdrawn from the antecubital vein of the participants into an ETDA vacutainer tube for subsequent analysis of the lipid profile.

Conditions
Healthy
Being tested
Conventional training, AI-led training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional trainingBehavioural

    Participants will perform a conventional training for 4 weeks, using low-moderate-high-low intensity progression training model

  • AI-led trainingBehavioural

    Participants will perform an AI-led training for 4 weeks

Study groups in NCT04357691
Study groupRoleWhat they receive
Healthy individuals (low-high-mod)OtherParticipants will undergo the calibration phase beginning with low intensity training, followed by high, and moderate intensity training. Each training intensity will be performed 3 days a week for 2 weeks
Receives: Behavioral: Conventional training; Behavioral: AI-led training
Healthy individuals (mod-high-low)OtherParticipants will undergo the calibration phase beginning with moderate intensity training, followed by high, and low intensity training. Each training intensity will be performed 3 days a week for 2 weeks
Receives: Behavioral: Conventional training; Behavioral: AI-led training
Healthy individuals (mod-low-high)OtherParticipants will undergo the calibration phase beginning with moderate intensity training, followed by low, and high intensity training. Each training intensity will be performed 3 days a week for 2 weeks.
Receives: Behavioral: Conventional training; Behavioral: AI-led training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in 2.4 km completion time following first cycle in phase 1

    Time taken to complete 2.4 km

    Measured: Baseline and Week 4 of phase 1 (phase 1 first cycle consist of 42 days)

  2. Changes in 2.4 km completion time following second cycle in phase 1

    Time taken to complete 2.4 km

    Measured: Baseline and Week 9 of phase 1 (phase 1 second cycle consist of 35 days)

  3. Changes in 2.4 km completion time following third cycle in phase 1

    Time taken to complete 2.4 km

    Measured: Baseline and Week 14 of phase 1 (phase 1 third cycle consist of 21 days)

  4. Changes in 2.4 km completion time following phase 2

    Time taken to complete 2.4 km

    Measured: Baseline and Week 6 of phase 2 (phase 2 consist of 49 days)

Secondary outcomes (10)
  1. Changes in VO2peak following first cycle in phase 1

    Measurement of oxygen uptake under maximal work capacity

    Measured: Baseline and Week 4 of phase 1 (phase 1 first cycle consist of 42 days)

  2. Changes in VO2peak following second cycle in phase 1

    Measurement of oxygen uptake under maximal work capacity

    Measured: Baseline and Week 9 of phase 1 (phase 1 second cycle consist of 35 days)

  3. Changes in VO2peak following third cycle in phase 1

    Measurement of oxygen uptake under maximal work capacity

    Measured: Baseline and Week 14 of phase 1 (phase 1 third cycle consist of 21 days)

  4. Changes in VO2peak following phase 2

    Measurement of oxygen uptake under maximal work capacity

    Measured: Baseline and Week 6 of phase 2 (phase 2 consist of 49 days)

  5. Resting blood lipids panel (triglycerides, cholesterols, phospholipids, sphingolipids, inflammatory lipids, testosterone, cortisol, endocannabinoids) in phase 1

    Lipid biomarkers related to metabolism, inflammation, fitness, health, and pain

    Measured: Week 1 of phase 1 (phase 1 consist of 98 days)

  6. Changes in blood lipids panel (triglycerides, cholesterols, phospholipids, sphingolipids, inflammatory lipids, testosterone, cortisol, endocannabinoids) pre- and post- training following first cycle in phase 1

    Lipid biomarkers related to metabolism, inflammation, fitness, health, and pain

    Measured: Week 2 and 3 of phase 1 (phase 1 first cycle consist of 42 days)

  7. Changes in blood lipids panel (triglycerides, cholesterols, phospholipids, sphingolipids, inflammatory lipids, testosterone, cortisol, endocannabinoids) pre- and post- training following second cycle in phase 1

    Lipid biomarkers related to metabolism, inflammation, fitness, health, and pain

    Measured: Week 7 and 8 of phase 1 (phase 1 second cycle consist of 35 days)

  8. Changes in blood lipids panel (triglycerides, cholesterols, phospholipids, sphingolipids, inflammatory lipids, testosterone, cortisol, endocannabinoids) pre- and post- training following third cycle in phase 1

    Lipid biomarkers related to metabolism, inflammation, fitness, health, and pain

    Measured: Week 12 and 13 of phase 1 (phase 1 third cycle consist of 21 days)

  9. Changes in resting blood lipids panel (triglycerides, cholesterols, phospholipids, sphingolipids, inflammatory lipids, testosterone, cortisol, endocannabinoids) in phase 2

    Lipid biomarkers related to metabolism, inflammation, fitness, health, and pain

    Measured: Week 1 and 7 of phase 2 (phase 2 consist of 49 days)

  10. Changes in blood lipids panel (triglycerides, cholesterols, phospholipids, sphingolipids, inflammatory lipids, testosterone, cortisol, endocannabinoids) pre- and post- training in phase 2

    Lipid biomarkers related to metabolism, inflammation, fitness, health, and pain

    Measured: Week 2, 4 and 5 of phase 2 (phase 2 consist of 49 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start25 May 2020 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04357691
Sponsor's protocol ID
Project CURATE
Status last verified
Apr 2020
First submitted
7 Apr 2020
Last updated
4 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is in compliance with the national personal data protection act. Institutions would need to abide to the data protection law when handling personal data. However, ample information has been provided in the inclusion and exclusion criteria to understand the participant's demographics used in this study.

Publications

  • Wang H, Lee DK, Chen KY, Chen JY, Zhang K, Silva A, Ho CM, Ho D. Mechanism-independent optimization of combinatorial nanodiamond and unmodified drug delivery using a phenotypically driven platform technology. ACS Nano. 2015 Mar 24;9(3):3332-44. doi: 10.1021/acsnano.5b00638. Epub 2015 Feb 23.

    PubMed 25689511
  • Rashid MBMA, Toh TB, Hooi L, Silva A, Zhang Y, Tan PF, Teh AL, Karnani N, Jha S, Ho CM, Chng WJ, Ho D, Chow EK. Optimizing drug combinations against multiple myeloma using a quadratic phenotypic optimization platform (QPOP). Sci Transl Med. 2018 Aug 8;10(453):eaan0941. doi: 10.1126/scitranslmed.aan0941.

    PubMed 30089632

Questions about this trial

What is this clinical trial studying?

A study testing Conventional training and AI-led training in people with Healthy, run by Wang Yongtai Raymond at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongtai, Raymond Wang, MSc (+65 90472892, phswyr@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in 2.4 km completion time following first cycle in phase 1 (time frame: Baseline and Week 4 of phase 1 (phase 1 first cycle consist of 42 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04357691, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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