C-Protein in Fatigue and Aging

NCT05926219 | Recruiting DMC

• 2 other identifiers: 11262017.042R21AG077125-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.

Conditions

Aging; Muscle Atrophy or Weakness; Sarcopenia in Elderly; Sarcopenia

Keywords

muscle; aging; elderly; myosin; protein; sarcomere; exercise; function; atrophy; contractile; strength; balance; mobility; MyBP-C; fiber; biopsy; skeletal muscle; fatigue

Outcome Measures

Primary Outcomes (1)

• Phosphorylation of myosin binding protein c (MyBP-C)

  Muscle tissue is immediately frozen after biopsy. Liquid chromatography and high resolution mass spectrometry will be used to do a full analysis of the phosphorylation sites on MyBP-C isolated from the biopsied muscle tissue.

  One week after the participant undergoes the biopsies.

Secondary Outcomes (4)

• Muscle fiber Force

  Within three weeks of the intervention and biopsies.

• Muscle fiber Tension

  Within three weeks of the intervention and biopsies.

• Muscle fiber Velocity

  Within three weeks of the intervention and biopsies.

• Muscle fiber Power

  Within three weeks of the intervention and biopsies.

Study Arms (1)

Fatigue

EXPERIMENTAL

Volunteers will perform one-legged knee extension exercise until fatigue while seated on an ergometer. Volunteers will then undergo bilateral skeletal muscle biopsies of the vastus lateralis muscle in their thigh.

Behavioral: Fatiguing Exercise

Interventions

Fatiguing Exercise BEHAVIORAL

Volunteers will perform knee extension exercise of the dominant limb while seated in a chair designed for exercise of the knee extensor muscle group. The chair will be equipped with a lever arm, aligned with the axis of rotation of the knee and fixed to the distal shank, 2 centimeters proximal to the ankle joint. The lever arm will be instrumented to provide resistance and measure velocity. The volunteers will perform 3-5 maximum voluntary contractions (MVC) to determine peak torque. Once established, volunteers will rest for 5 minutes before initiating the fatigue protocol, whereby they will perform repeated MVC of the dominant limb against resistance equal to or less than 50% of MVC until range of motion cannot be maintained. Because the goal of this exercise is to uniformly fatigue the quadriceps muscle group, this exercise will be performed continuously. It is expected to take between 1 and 3 minutes to achieve the desired level of fatigue.

Fatigue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages 18-35 or 65-80 years
• Healthy by self-report
• Willing to participate in all aspects of the study design including muscle biopsy, unilateral exercise, and physical activity monitoring
• Fluent in English (due to lack of translation services, it is not practical to conduct the study using a language other than English).

You may not qualify if:

• Orthopaedic limitation (severe knee osteoarthritis, prior joint replacement, etc.).
• Volunteer has dementia or related mental issues that potentially put the subject at risk as determined by prior diagnosis.
• Volunteer has known untreated endocrine disease (hypo/hyper thyroidism, Addison's Disease or Cushing's syndrome, etc.)
• Volunteer has untreated/poorly-controlled hypertension (stage 2, per American College of Cardiology \[\>140/90 mmHg\]).
• Volunteer has significant heart, liver, kidney or respiratory disease.
• Volunteer has diabetes (insulin dependent or non-insulin dependent).
• Volunteer has known coagulopathies.
• Volunteer has taken anabolic steroids in the prior six months.
• Volunteer has received treatment for cancer (other than effective Mohs Surgery for successful removal of basal cell or squamous cell carcinomas)
• Unexpected weight loss \>5kg is last 12 months
• Volunteer is an active smoker or quit within the last year.
• Volunteer has known current alcohol or drug use disorder (AUD; defined as binge drinking of \>4 days in the last month. Binge drinking is \>5 drinks for men and \>4 drinks for women, per occasion). Or, if a volunteer reports drinking in excess of "low risk" per NIAAA (\>7 drinks/week for men and \>3 drinks/day for women and \>14 drinks/week and \>4 drinks/day).
• Volunteer has a diagnosed neuromuscular disorder.
• Volunteer has allergy to lidocaine.

Sponsors & Collaborators

• University of Oregon: lead
• Wu Tsai Human Performance Alliance: collaborator
• National Institutes of Health (NIH): collaborator
• Oregon Health and Science University: collaborator
• Washington State University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy; Asthenia; Sarcopenia; Motor Activity; Atrophy; Fatigue

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Damien M Callahan, Ph.D.

  University of Oregon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien M Callahan, Ph.D.

CONTACT

541-346-5040; damienc@uoregon.edu

Karen Wiedenfeld Needham, BS

CONTACT

541-346-7610; needham@uoregon.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 3, 2023
• Study Start: November 6, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)