Molecular Optimization Via Exercise (MOVE)

NCT06540287 | Recruiting

• 1 other identifier: BUCK_2401
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate characteristics of muscle, blood, and urine samples from older adults (ages 65-80) who are either sedentary or athletes performing at an elite level for their age. This observational study will include bio-specimen collection, as well as physical and cognitive function testing and body composition.

Conditions

Aging

Keywords

Biomarkers; Healthy older adults; Older elite athletes

Outcome Measures

Primary Outcomes (2)

• Muscle cellular aging - spatial transcriptomics

  Differences between athletes and sedentary in muscle spatial transcriptomic between OEA and HOA groups

  Day 2

• Muscle cellular aging - single cell transcriptomics

  Differences between athletes and sedentary in muscle single cell transcriptomic between OEA and HOA groups

  Day 2

Secondary Outcomes (14)

• Differences between concentration of proteins in the muscle

  Day 2

• Differences between concentration of metabolites in the muscle

  Day 2

• Differences between function of muscle mitochondria

  Day 2

• Blood metabolites

  Day 2

• Blood proteins

  Day 2

Other Outcomes (9)

• Body composition - BIA

  Day 1

• Body composition - muscle mass

  Day 2

• Cognitive function - Montreal Cognitive Assessment

  Day 1

Study Arms (2)

Group 1 cohort: Healthy Older Adults (HOA)

This cohort will include healthy older adults, aged 65y or over, who participate in less than 60 minutes of structured exercise each week.

Other: Observational

Group 2 cohort: Elite Older Athletes (EOA)

This cohort will include healthy older adults, aged 65y or over, who are elite athletes for their age (determined by interview and VO2max)

Other: Observational

Interventions

Observational OTHER

No intervention

Group 1 cohort: Healthy Older Adults (HOA); Group 2 cohort: Elite Older Athletes (EOA)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female Older Endurance Athletes (OEA) at/over the age of 65 - 80 y (exercising at an elite level for their age - assessed by interview and review of training data and competition/results) Male and female Healthy Older Adults (HOA) at/over the age of 65 -80 y who do not regularly exercise (no more than one day per week lasting no more than 60 mins of regular structured exercise)

You may not qualify if:

• Subject requires assistance with any activity of daily living, excluding continence.
• Subject lives in an institutional setting (skilled nursing facility or residential care facility for the elderly).
• Abnormal bleeding or coagulopathy (self-report): History of a bleeding disorder, wound healing disorder or clotting abnormality.
• Female participants must be post-menopause.
• Musculoskeletal conditions that would prevent completion of any required exercise testing.
• Elevated blood pressure readings (screening test): Resting Systolic Blood Pressure (SBP) ≥150 mmHg or resting Diastolic Blood Pressure (DBP) ≥90 mmHg
• Diabetes (self-report and screening tests): Treatment with any hypoglycemic agents (self-report), fasting glucose \>125 mg/dL (screening test; may reassess once), use of hypoglycemic drugs for non-diabetic reasons (self-report).
• Pulmonary (self-report): Clinical diagnosis of any chronic pulmonary disease that limits exercise capacity.
• Cardiovascular (self-report, screening test, and clinician judgement): Congestive heart failure, coronary artery disease, significant valvular disease, congenital heart disease, serious arrhythmia, pulmonary embolism, stroke, or symptomatic peripheral artery disease (self-report, screening test). Specific criteria used to determine whether a volunteer can undergo the screening CPET follow the American Heart Association (AHA) Criteria \[6\]. Inability to complete the CPET. Reassessment of the CPET may be allowed under some circumstances (e.g., test was not a maximal effort)
• Abnormal blood lipid profile (screening test): Fasting triglycerides \>500 mg/dL. Low-density lipoprotein cholesterol (LDL-C) \>190 mg/dL
• Cancer (self-report): History of cancer treatment (other than non-melanoma skin cancer, or chronic lymphocytic leukemia) and not "cancer-free "for at least 2 years. Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months.
• Chronic active or latent infection (self-report): Active or latent infections requiring chronic antibiotic or anti-viral treatment, excluding herpes simplex virus. Chronic active infection whether on chronic antimicrobials or not. Human Immunodeficiency Virus. Active hepatitis B or C undergoing antiviral therapy. Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded.
• Liver enzyme tests (alanine transaminase, aspartate transaminase) (screening test): \>2 times the laboratory upper limit of normal. Reassessment during screening may be allowed under some conditions (e.g., recent use of acetaminophen). Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting.
• Chronic renal insufficiency (screening test): Estimated glomerular filtration rate \<60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation. Subjects must be able to produce urine. Reassessment may be allowed under some conditions (e.g., questionable hydration status or other acute renal insult)
• Hematocrit (screening test): Hematocrit \>3 points outside of the local normal laboratory ranges for women and men. Reassessment may be allowed under certain conditions. Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting.

Sponsors & Collaborators

• Buck Institute for Research on Aging: lead

Study Sites (1)

Buck Institute for Research on Aging

Novato, California, 94945, United States

RECRUITING

Related Publications (2)

• Harridge SD, Lazarus NR. Physical Activity, Aging, and Physiological Function. Physiology (Bethesda). 2017 Mar;32(2):152-161. doi: 10.1152/physiol.00029.2016.

  PMID: 28228482 BACKGROUND

• Duggal NA, Pollock RD, Lazarus NR, Harridge S, Lord JM. Major features of immunesenescence, including reduced thymic output, are ameliorated by high levels of physical activity in adulthood. Aging Cell. 2018 Apr;17(2):e12750. doi: 10.1111/acel.12750. Epub 2018 Mar 8.

  PMID: 29517845 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Serum White Blood Cells Muscle biopsy

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• John C Newman, MD PhD

  Buck Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Briannaa Stubbs, DPhil

CONTACT

4152092000; bstubbs@buckinstitute.org

John C Newman, MD PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 6, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)