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NCT Number: NCT07093216

Healthy Aging Through Optimized Exercise

here is enormous variation in how individuals respond to exercise and understanding the factors that drive this variation will guide individualized exercise prescriptions to improve or maintain health into older age. This study will help to elucidate reasons for the variation in the responses to exercise in older adults.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

here is enormous variation in how individuals respond to exercise and understanding the factors that drive this variation will guide individualized exercise prescriptions to improve or maintain health into older age. Our multidisciplinary team will apply Multiphase Optimization Strategy Framework (MOST) principles to addresses the impacts of exercise intervention components (e.g. exercise timing, aerobic exercise intensity levels, resistance exercise intensity levels, and training volume levels), as well as participant-specific factors (e.g. age, sex, race, BMI, and medication use), on health domains of Intrinsic Capacity (locomotion, vitality, sensory, psychological, and cognition) among older adults in response to six months of supervised, center-based exercise training. This approach - unprecedented in the fields of exercise and aging - will provide comprehensive evidence to more fully understand the variation in the responses to exercise in older adults.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent prior to any study procedure
  • 60+ years of age
  • <120 min/wk of self-reported moderate physical activity as assessed by Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire13
  • Evidence of impairment in one or more Intrinsic Capacity domains (see section 3.2)
  • Passage of a physical exam and diagnostic, graded exercise test with 12-lead ECG reviewed by a cardiologist or otherwise credentialed clinician.

Exclusion criteria

  • End-stage disease and/or a life expectancy less than one year
  • Resistant hypertension, defined as BP > 140/90, despite the use of three or more anti-hypertensive drugs
  • Chronic kidney disease
  • Serum creatinine >2.5 mg/dL in men or >2.0 mg/dL in women
  • Serum potassium >5.0 mEq/L
  • Urinary protein > 1 on dipstick
  • Abnormal liver enzymes (AST, ALT, or alkaline phosphatase > 2.5 times the upper limit of normal)
  • Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
  • Acute myocardial infarction identified by ECG
  • Current treatment for malignancy
  • Known diagnosis of dementia
  • Any other disease or condition that would preclude completion of all testing and exercise training
  • Any other condition that would interfere with testing or increase risk of complications during exercise
  • Any other condition or events considered exclusionary by the PIs and/or study clinicians.

Treatment and study plan

Exercise

Behavioral

6 month exercise intervention

Primary outcomes

  1. Intrinsic Capacity

    Time frame: 6 months

    Single composite score of results of multiple tests across five domains: 1) Locomotion, 2) Vitality, 3) Sensory, 4) Psychological, and 5) Cognition

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Fulton

CONTACT

[email protected]

205.996.4086

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Understanding Response Variability to Optimize Exercise Efficacy for Improving Health Among Older Adults

Acronym: HELIOS

Important dates

Study start
2028
Primary completion
2035
Study completion
2035
First posted
Jul 30, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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