AgingNCT05926219
C-Protein in Fatigue and Aging
A study testing Fatiguing Exercise in people with Aging and Muscle Atrophy or Weakness, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Muscle Atrophy or Weakness, Sarcopenia in Elderly
- What is being tested?
- Fatiguing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oregon
Eugene, Oregon, 97403
Damien M Callahan, Ph.D., 458-205-5343, damienc@uoregon.edu
Damien M Callahan, Ph.D.
About this study
Official title: Skeletal Muscle Myosin Binding Protein C in Fatigue and Aging
This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.
Read the 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
- Being tested
- Fatiguing Exercise
- Keywords
- muscle, aging, elderly, myosin, protein, sarcomere, exercise, function, atrophy, contractile, strength, balance, mobility, MyBP-C, fiber, biopsy, skeletal muscle, fatigue
- Medical subject headings
- Muscular Atrophy, Asthenia, Sarcopenia, Motor Activity, Atrophy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatiguing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fatiguing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after the participant undergoes the biopsies.
Secondary outcomes (4)
Muscle fiber Force
Ex vivo assessment of Force (mN) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Measured: Within three weeks of the intervention and biopsies.
Muscle fiber Tension
Ex vivo assessment of Tension (kPa) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Measured: Within three weeks of the intervention and biopsies.
Muscle fiber Velocity
Ex vivo assessment of Velocity (Lo/s) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Measured: Within three weeks of the intervention and biopsies.
Muscle fiber Power
Ex vivo assessment of Power (w/L) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Measured: Within three weeks of the intervention and biopsies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start6 Nov 2017
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Tsai Human Performance Alliance, National Institutes of Health (NIH), Oregon Health and Science University, Washington State University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Damien M Callahan, Ph.D., Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926219
- Sponsor's protocol ID
- 11262017.042
- Other IDs
- R21AG077125-01
- Status last verified
- May 2026
- First submitted
- 31 May 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Myosin Binding Protein C in Fatigue and Aging
- ClinicalTrials.gov ID
- NCT05926219
- Acronym / sponsor ID
- 11262017.042
- Conditions
- Aging, Muscle Atrophy or Weakness, Sarcopenia in Elderly, Sarcopenia
- Keywords
- muscle, aging, elderly, myosin, protein, sarcomere, exercise, function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Wu Tsai Human Performance Alliance, National Institutes of Health (NIH), Oregon Health and Science University, Washington State University, National Institute on Aging (NIA)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue | Experimental | Behavioral: Fatiguing ExerciseVolunteers 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatiguing ExerciseVolunteers 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. | Behavioural | Fatigue |
Primary outcome
Phosphorylation of myosin binding protein c (MyBP-C)
Time frame: One week after the participant undergoes the biopsies.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damien M Callahan, Ph.D. principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatiguing Exercise in people with Aging and Muscle Atrophy or Weakness, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien M Callahan, Ph.D. (541-346-5040, damienc@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphorylation of myosin binding protein c (MyBP-C) (time frame: One week after the participant undergoes the biopsies.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.