NCT07093216

Brief 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. This study will help to elucidate reasons for the variation in the responses to exercise in older adults.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
60mo left

Started May 2026

Longer than P75 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Apr 2031

First Submitted

Initial submission to the registry

July 14, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2031

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

July 14, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

Intrinsic CapacityExercise

Outcome Measures

Primary Outcomes (1)

  • Intrinsic Capacity

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

    6 months

Study Arms (5)

Dose

EXPERIMENTAL

Testing Dose of Exercise

Behavioral: Exercise

Intensity

EXPERIMENTAL

Testing Intensity of Effort

Behavioral: Exercise

Mode

EXPERIMENTAL

Resistance vs Aerobic

Behavioral: Exercise

Volume

EXPERIMENTAL

Amount of Exercise Performed

Behavioral: Exercise

Time of Day

EXPERIMENTAL

Time of Day Exercise Performed

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

6 month exercise intervention

DoseIntensityModeTime of DayVolume

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent prior to any study procedure
  • + 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Karen Fulton

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 30, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

April 30, 2031

Study Completion (Estimated)

April 30, 2031

Last Updated

July 30, 2025

Record last verified: 2025-07