AgingHELIOSNCT07093216
Healthy Aging Through Optimized Exercise
A study testing Exercise in people with Aging, run by University of Alabama at Birmingham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2028to 30 Apr 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Understanding Response Variability to Optimize Exercise Efficacy for Improving Health Among Older Adults
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.
Read the detailed description
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.
- Conditions
- Aging
- Being tested
- Exercise
- Keywords
- Intrinsic Capacity, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
6 month exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Dose | Experimental | Testing Dose of Exercise Receives: Behavioral: Exercise |
| Intensity | Experimental | Testing Intensity of Effort Receives: Behavioral: Exercise |
| Mode | Experimental | Resistance vs Aerobic Receives: Behavioral: Exercise |
| Volume | Experimental | Amount of Exercise Performed Receives: Behavioral: Exercise |
| Time of Day | Experimental | Time of Day Exercise Performed Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic Capacity
Single composite score of results of multiple tests across five domains: 1) Locomotion, 2) Vitality, 3) Sensory, 4) Psychological, and 5) Cognition
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Dec 2028 (estimated)
- Primary completion30 Apr 2035 (estimated)
- Study completion30 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas W. Buford, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093216
- Sponsor's protocol ID
- 300013021
- Acronym
- HELIOS
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Response Variability to Optimize Exercise Efficacy for Improving Health Among Older Adults
- ClinicalTrials.gov ID
- NCT07093216
- Acronym / sponsor ID
- HELIOS / 300013021
- Conditions
- Aging
- Keywords
- Intrinsic Capacity, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2028 (estimated)
- Primary completion
- 30 Apr 2035 (estimated)
- Study completion
- 30 Apr 2035 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose | Experimental | Behavioral: ExerciseTesting Dose of Exercise |
| Intensity | Experimental | Behavioral: ExerciseTesting Intensity of Effort |
| Mode | Experimental | Behavioral: ExerciseResistance vs Aerobic |
| Volume | Experimental | Behavioral: ExerciseAmount of Exercise Performed |
| Time of Day | Experimental | Behavioral: ExerciseTime of Day Exercise Performed |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise6 month exercise intervention | Behavioural | Dose, Intensity, Mode, Time of Day, Volume |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Active, not recruiting
Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
Aging, Longevity
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging, run by University of Alabama at Birmingham.
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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Fulton (205.996.4086, fulton31@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrinsic Capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.