EaRneST: Exercise and CiRulating MetabolomicS: A Pilot Randomized Controlled Study
EaRneST
1 other identifier
interventional
30
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
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
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedStudy Start
First participant enrolled
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedApril 5, 2024
March 1, 2021
9 months
July 31, 2018
April 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Metabolmic Profile
3 months
Study Arms (2)
Group A - Intervention
OTHERBaseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis, Exercise intervention from Visit 2 to Visit 13, End of 3 month assessment.
Group B- Control
OTHERBaseline procedure, Bio specimen collection , Six minute walk, Musculoskeletal Analysis \& End of 3 month assessment.
Interventions
Refer to detailed study Description
Eligibility Criteria
You may qualify if:
- Aged 40 years old and above
- At least Grade 1 Diastolic Dysfunction
- Willing and able to give informed consent for participation for the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart Centre Singaporelead
- Duke-NUS Graduate Medical Schoolcollaborator
Study Sites (1)
National Heart Center Singapore
Singapore, 169609, Singapore
Related Publications (1)
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.
PMID: 38704414DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Su-Mei Angela Koh, MBBS
National Heart Centre Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 6, 2018
Study Start
February 19, 2019
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
April 5, 2024
Record last verified: 2021-03