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Recruiting NCT05926219

C-Protein in Fatigue and Aging

No phase Interventional Aging Muscle Atrophy or Weakness Sarcopenia in Elderly Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fatiguing Exercise.
Who it may be relevant to
Registry conditions: Aging, Muscle Atrophy or Weakness, Sarcopenia in Elderly, Sarcopenia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Skeletal Muscle Myosin Binding Protein C in Fatigue and Aging

Overview

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.

Interventions

  • Behavioral 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 establ

Primary outcome measures

  • Phosphorylation of myosin binding protein c (MyBP-C) [Time frame: One week after the participant undergoes the biopsies.]
Secondary outcome measures (4)
  • Muscle fiber Force [Time frame: Within three weeks of the intervention and biopsies.]
  • Muscle fiber Tension [Time frame: Within three weeks of the intervention and biopsies.]
  • Muscle fiber Velocity [Time frame: Within three weeks of the intervention and biopsies.]
  • Muscle fiber Power [Time frame: Within three weeks of the intervention and biopsies.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Oregon — Eugene

Identifiers

NCT: NCT05926219 · 11262017.042 · R21AG077125-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗