NCT04799171

Brief Summary

The goal of the study is to determine whether aerobic or resistant exercise can improve in vivo mitochondrial capacity of skeletal muscle cells similarly in healthy younger, middle aged and older adults. This confers long-term changes in this tissue which in-turn contribute to improved metabolic health and functional capacity through epigenetic regulation of novel exercise response genes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed
Last Updated

August 22, 2025

Status Verified

October 1, 2024

Enrollment Period

3.8 years

First QC Date

March 11, 2021

Last Update Submit

August 18, 2025

Conditions

Keywords

Isometric contraction exercise

Outcome Measures

Primary Outcomes (2)

  • Pre-training 31P MRS measurement - Phosphocreatine recovery rate

    The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.

    Baseline visit - before any muscle biopsies or exercise training.

  • Post-training 31P MRS measurement - Phosphocreatine recovery rate

    The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.

    After week 12 visit - after all muscle biopsies and exercise training.

Study Arms (3)

Young Adults (Age group 18-39)

ACTIVE COMPARATOR

31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.

Other: Isometric Contraction Exercise - Young Adults (Age group 18-39)

Middle Aged Adults (Age group 40-59)

ACTIVE COMPARATOR

31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.

Other: Isometric Contraction Exercise - Middle Age Adults (Age group 40-59)

Old Adults (Age group >60)

ACTIVE COMPARATOR

31P-Magnetic Resonance Spectroscopy exam on one thigh to measure mitochondrial capacity non-invasively after exercise training.

Other: Isometric Contraction Exercise - Old Adults (Age group >60)

Interventions

Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.

Young Adults (Age group 18-39)

Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.

Middle Aged Adults (Age group 40-59)

Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.

Old Adults (Age group >60)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged 18 - 39 y
  • Body Mass Index (BMI) \>19 to \<35 kg/m2
  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged 40 - 59 y
  • Body Mass Index (BMI) \>19 to \<35 kg/m2
  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged \>=60 y
  • Body Mass Index (BMI) \>19 to \<35 kg/m2

You may not qualify if:

  • Diabetes (self-report and screening tests)
  • Treatment with any hypoglycemic agents (self-report) or A1c \>6.4 (screening test; may reassess once if 6.5-6.7)
  • Fasting glucose \>125 (screening test; may reassess once)
  • Use of hypoglycemic drugs (e.g., metformin) for non-diabetic reasons (self-report)
  • Abnormal bleeding or coagulopathy (self-report)
  • History of a bleeding disorder or clotting abnormality
  • Thyroid disease (screening test)
  • Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory
  • Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for ≥3 months prior to retesting
  • Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment
  • Pulmonary (self-report)
  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Metabolic bone disease (self-report)
  • History of non-traumatic fracture from a standing height or less
  • Current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen
  • +104 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Owen T Carmichael, PhD

    Director, Biomedical Imaging Center, PBRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Biomedical Imaging Center

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

August 2, 2021

Primary Completion

May 12, 2025

Study Completion

May 12, 2025

Last Updated

August 22, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

As a MoTrPAC ancillary study, we will comply with all regulations of the MoTrPAC Ancillary Study Committee regarding sharing of data generated from MoTrPAC participants. We will follow up on any data irregularities identified by the Bioinformatics Core as part of their data cleaning process. The Bioinformatics Core will then make our MRS summary data ancillary study data to the community together with the MoTrPAC main study data and data from any other ancillary studies that arise. We are familiar with the NIH policies regarding data sharing, and during our data transfer to the main MoTrPAC study we will comply with local, state, and federal laws, such as the Privacy Rule, a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA).

Locations