C-Protein in Fatigue and Aging

NCT ID: NCT05926219

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-06
• Study Completion Date: 2027-01-31

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.

Detailed Description

Age-related muscle atrophy and contractile dysfunction have been well described at the cellular level, but the molecular mechanisms that contribute to this dysfunction are poorly understood. Improved understanding of these mechanisms is critically important for the improvement of physical rehabilitation in older adults at risk for mobility impairment and physical disability. Our studies will pursue pre-clinical evidence that post translational modification of specific proteins in skeletal muscle lead to an "aging phenotype" in skeletal muscle that may unlock new strategies for improving physical function in older adults with physical frailty.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fatigue

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.

Group Type: EXPERIMENTAL

Fatiguing Exercise

Intervention Type: 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.

Interventions

Fatiguing Exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wu Tsai Human Performance Alliance

UNKNOWN

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Washington State University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien M Callahan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

University of Oregon

Eugene, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Damien M Callahan, Ph.D.

Role: CONTACT

damienc@uoregon.edu

541-346-5040

Karen Wiedenfeld Needham, BS

Role: CONTACT

needham@uoregon.edu

541-346-7610

Facility Contacts

Damien M Callahan, Ph.D.

Role: primary

damienc@uoregon.edu

458-205-5343

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

R21AG077125-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11262017.042

Identifier Type: -

Identifier Source: org_study_id