NCT04357691

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

April 7, 2020

Last Update Submit

April 30, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

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

    Time taken to complete 2.4 km

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

  • Changes in 2.4 km completion time following second cycle in phase 1

    Time taken to complete 2.4 km

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

  • Changes in 2.4 km completion time following third cycle in phase 1

    Time taken to complete 2.4 km

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

  • Changes in 2.4 km completion time following phase 2

    Time taken to complete 2.4 km

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

Secondary Outcomes (10)

  • Changes in VO2peak following first cycle in phase 1

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

  • Changes in VO2peak following second cycle in phase 1

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

  • Changes in VO2peak following third cycle in phase 1

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

  • Changes in VO2peak following phase 2

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

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

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

  • +5 more secondary outcomes

Study Arms (3)

Healthy individuals (low-high-mod)

OTHER

Participants 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

Behavioral: Conventional trainingBehavioral: AI-led training

Healthy individuals (mod-high-low)

OTHER

Participants 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

Behavioral: Conventional trainingBehavioral: AI-led training

Healthy individuals (mod-low-high)

OTHER

Participants 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.

Behavioral: Conventional trainingBehavioral: AI-led training

Interventions

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

Healthy individuals (low-high-mod)Healthy individuals (mod-high-low)Healthy individuals (mod-low-high)
AI-led trainingBEHAVIORAL

Participants will perform an AI-led training for 4 weeks

Healthy individuals (low-high-mod)Healthy individuals (mod-high-low)Healthy individuals (mod-low-high)

Eligibility Criteria

Age21 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 25689511BACKGROUND
  • 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.

    PMID: 30089632BACKGROUND

Study Officials

  • Kai Wei, Jason Lee, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR
  • Dean Ho, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongtai, Raymond Wang, MSc

CONTACT

Cherh Chiet, Ivan Low, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 22, 2020

Study Start

May 25, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

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.

Locations