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CompletedNCT03617653EaRneSTUpdated Apr 5, 2024

EaRneST: Exercise and CiRulating MetabolomicS: A Pilot Randomized Controlled Study

An interventional study of Group A in Cardiovascular Disease Other, sponsored by National Heart Centre Singapore. Completed at 1 site in Singapore. Open to participants aged 40 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by National Heart Centre Singapore · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 99 Years
Sex
All
01

Study summary

Brief Summary The purpose of this study is to investigate how circulating metabolites mediate changes in heart function after exercise intervention.

Condition or disease :Cardiovascular function

Intervention/treatment Cardiovascular: Echocardiography Other: Vascular Stiffness Other: Metabolomics (Blood)

Read the detailed description

Detailed Description The purpose of the study is to determine the effect of a structured exercise intervention on mitochondrial fuel metabolism and cardiovascular function. Participants with diastolic dysfunction will undergo a structured exercise intervention.

Group A (intervention) will undergo exercise intervention for three months and Group B (control) will not receive the exercise intervention. At the start of the study and upon completion, all participants will undergo cardiovascular tests to measure cardiovascular function, as well bio-specimen (blood and urine) collection for metabolic profiling.

Study Design Study Type : Randomized controlled trial Estimated Enrollment :40 participants Time Perspective:Prospective Official Title:EaRneST: Exercise and CiRculating MetabolomicS: A Pilot Randomized Controlled Study Study Start Date :July 2018 Estimated Primary Completion Date :Nov 2019 Estimated Study Completion Date : Nov 2019

Groups and Cohorts Group/Cohort :Group A Intervention/treatment Visit 1. Baseline procedures

  1. Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.

    Resting electrocardiography will be performed to ascertain sinus rhythm.

  2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.
  3. Six-minute walk test The Six-Minute Walk Test is a shuttle walk test.
  4. Musculoskeletal Analysis Participants will undergo focused examinations that include measurement of height, weight, body mass index, waist circumference, body composition analysis.

Visit 2 to Visit 13. One time per week exercise intervention for a total of three months

Visit 14: End of three months' procedures.

  1. Cardiovascular measurements Echocardiography Resting electrocardiography will be performed to ascertain sinus rhythm.
  2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.
  3. Six-minute walk test
  4. Musculoskeletal Analysis

Group B Visit 1. Baseline procedures

  1. Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Standard transthoracic echocardiographic examination will be performed according to established laboratory practice using standard commercially available machines.

    Resting electrocardiography will be performed to ascertain sinus rhythm.

  2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.
  3. Six-minute walk test The Six-Minute Walk Test is a shuttle walk test.
  4. Musculoskeletal Analysis Participants will undergo focused examinations that include measurement of height, weight, body mass index, waist circumference, body composition analysis.

Visit 2: End of three months' procedures.

  1. Cardiovascular measurements Arterial stiffness assessment by non-invasive brachial blood pressure machine Echocardiography Resting electrocardiogram will be performed to ascertain heart rhythm.
  2. Biospecimen collection Fresh blood, urine specimens will be collected for metabolomics.
  3. Six-minute walk test
  4. Musculoskeletal Analysis Outcome Measures
02

Conditions studied

  • Cardiovascular Disease Other
03

In context

Lead sponsor

National Heart Centre Singapore is the lead sponsor of 63 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 40 years old and above
  • At least Grade 1 Diastolic Dysfunction
  • Willing and able to give informed consent for participation for the study

Exclusion criteria

Exclusion Criteria:

  • History of cardiovascular disease
  • History of cancer
  • History of stroke
  • Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension
  • Low blood pressure (systolic blood pressure \<90mmHg or diastolic blood pressure \<40mmHg)
  • Acute pulmonary embolus or pulmonary infarction
  • Acute myocarditis or pericarditis
  • Suspected or known dissecting aneurysm
  • Acute systemic infection
  • Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis or myxedema)
  • Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Other
    Group A - Intervention

    Baseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis, Exercise intervention from Visit 2 to Visit 13, End of 3 month assessment.

    Diagnostic Test: Group A

  • Other
    Group B- Control

    Baseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis \& End of 3 month assessment.

    Diagnostic Test: Group A

Interventions

  • Diagnostic testGroup A

    Refer to detailed study Description

    Also known as: six minute walk test, exercise intervention

06

What researchers measure

Primary outcomes

  1. Changes in Metabolmic Profile

    Time frame: 3 months

07

Study locations

1 site
  • National Heart Center Singapore
    Singapore, 169609, Singapore
08

References and documents

Publications

  • Wong JJ, Ho JS, Teo LLY, Wee HN, Chua KV, Ching J, Gao F, Tan SY, Tan RS, Kovalik JP, Koh AS. Effects of short-term moderate intensity exercise on the serum metabolome in older adults: a pilot randomized controlled trial. Commun Med (Lond). 2024 May 4;4(1):80. doi: 10.1038/s43856-024-00507-w. PubMed 38704414 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03617653
Lead sponsor
National Heart Centre Singapore
Collaborators
Duke-NUS Graduate Medical School
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Feb 19, 2019
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019
Last update
Apr 5, 2024

Study contacts

Su-Mei Angela Koh, MBBS
principal investigator · National Heart Centre Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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