SarcopeniaNCT01477164
Effects of Aerobic and Resistance Training on Accumulation of Old, Modified Proteins in Young and Older Adults
A study testing High intensity aerobic exercise, Resistance exercise training and Combined in people with Sarcopenia, run by Mayo Clinic at 1 site in United States.
Trial summary
Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and function in older people. Exercise can increase the making of new proteins and removal of older proteins, but it is not known if the effect changes with aging or type of exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- High intensity aerobic exercise, Resistance exercise training and Combined
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy
- 18 to 30 years or 65 to 80 years old
- Male and female
Who cannot join
- Regular exercise program
- Smoking
- Metabolic disease (diabetes, cardiovascular disease, cancer, thyroid disorders)
- Pregnancy
- Inability to exercise
- Overweight or obesity
- Drugs known to impair metabolic function (statin, beta-blocker, anti-inflammatory)
- Allergies to lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and function in older people. Exercise can increase the making of new proteins and removal of older proteins, but it is not known if the effect changes with aging or type of exercise. The investigators will determine the ability for endurance, resistance, or a combination of exercise training to remove older-damaged proteins and make newer-functional muscle proteins in groups of younger and older people. The investigators will particularly study protein that are involved with energy production (mitochondrial proteins) and force production (contractile proteins).
Hypothesis 1: Older people will have greater accumulation of damaged proteins than younger people.
Read more
Hypothesis 2: Aerobic exercise will decrease the accumulation of damaged forms of contractile and mitochondrial proteins in younger and older people.
Hypothesis 3: Resistance exercise will decrease the accumulation of damaged forms of contractile proteins in younger and older people.
Read the detailed description
The loss of muscle mass and function with age leads to high social and economic costs. Lifestyle interventions that can help maintain muscle mass and function can be beneficial to improve health and decrease the costs associated with loss of independence in the elderly. Muscle proteins accumulate damage during aging, which is suggested to lead to loss of function. The biological processes that remove damaged proteins and synthesis new proteins appear to be decreased with aging. Exercise is known to increase the processes that remove older and synthesis newer muscle proteins and may be an effect lifestyle intervention to improve muscle quality and function. Additionally, specific types of proteins appear to decay with age including contractile and mitochondrial proteins. Different types of exercise training can increase the making of specific proteins. The investigators will examine the ability for aerobic and resistance training to increase the quality of mitochondrial and contractile proteins between younger and older people.
- Conditions
- Sarcopenia
- Being tested
- High intensity aerobic exercise, Resistance exercise training, Combined
- Keywords
- Exercise, Aging, Sarcopenia, Muscle function
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity aerobic exerciseBehavioural
Participants will perform 12-weeks of high intensity aerobic training. Training will be 5-days per week. Three days (e.g. Monday, Wednesday and Friday) will include repeated bouts of cycling for 4-minutes at ~90% maximal effort followed by 3 minutes of active rest. The other two days (e.g. Tuesday and Thursday) will be treadmill exercise for 45 minutes at 70% of maximal effort.
Resistance exercise trainingBehavioural
Participants will perform 12-weeks of resistance exercise training. Training will be 5-days per week of daily sessions of 60 minutes that include resistance exercise for all major muscle groups.
CombinedBehavioural
The combined group will be assessed before and after 12 weeks of no exercise training, then again following 12 weeks of combined aerobic and resistance exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Training | Experimental | Participants will perform 12-weeks of high intensity aerobic training. Receives: Behavioral: High intensity aerobic exercise |
| Combined | Active comparator | The combined group will have 12-weeks of no exercise followed by 12-weeks of combined aerobic and resistance exercise training. Assessments will be made at three time points: baseline, after 12-weeks of no training, and after 12-weeks of combined training. Receives: Behavioral: Combined |
| Resistance Exercise Training | Experimental | Participants will perform 12-weeks of resistance exercise training. Receives: Behavioral: Resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle protein synthesis rate
The investigators will determine the rate of incorporation of stable isotope amino acid tracers in skeletal muscle proteins during several hours of rest. The measurement will be an average resting muscle protein synthesis rate (% new muscle protein per hour) and will be performed at baseline and following 12 weeks of exercise training.
Measured: Approximately 14 weeks for the endurance or resistance training groups and approximately 28 weeks for the combined group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Sreekumaran Nair, Mayo Clinic
- Investigators
- K. Sreekumaran Nair, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477164
- Sponsor's protocol ID
- 10-005853
- Status last verified
- Aug 2017
- First submitted
- 28 Sep 2011
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pataky MW, Heppelmann CJ, Sevits KJ, Asokan AK, Kumar AP, Klaus KA, Dasari S, Kunz HE, Strub MD, Robinson MM, Coon JJ, Lanza IR, Adams CM, Nair KS. Aerobic and resistance exercise-regulated phosphoproteome and acetylproteome modifications in human skeletal muscle. Nat Commun. 2025 Jul 1;16(1):5700. doi: 10.1038/s41467-025-60049-0.
PubMed 40595512Zhang X, Habiballa L, Aversa Z, Ng YE, Sakamoto AE, Englund DA, Pearsall VM, White TA, Robinson MM, Rivas DA, Dasari S, Hruby AJ, Lagnado AB, Jachim SK, Granic A, Sayer AA, Jurk D, Lanza IR, Khosla S, Fielding RA, Nair KS, Schafer MJ, Passos JF, LeBrasseur NK. Characterization of cellular senescence in aging skeletal muscle. Nat Aging. 2022 Jul;2(7):601-615. doi: 10.1038/s43587-022-00250-8. Epub 2022 Jul 15.
PubMed 36147777
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic and Resistance Training on Accumulation of Old, Modified Proteins in Young and Older Adults
- ClinicalTrials.gov ID
- NCT01477164
- Acronym / sponsor ID
- 10-005853
- Conditions
- Sarcopenia
- Keywords
- Exercise, Aging, Sarcopenia, Muscle function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and function in older people. Exercise can increase the making of new proteins and removal of older proteins, but it is not known if the effect changes with aging or type of exercise. The investigators will determine the ability for endurance, resistance, or a combination of exercise training to remove older-damaged proteins and make newer-functional muscle proteins in groups of younger and older people. The investigators will particularly study protein that are involved with energy production (mitochondrial proteins) and force production (contractile proteins).
Hypothesis 1: Older people will have greater accumulation of damaged proteins than younger people.
Hypothesis 2: Aerobic exercise will decrease the accumulation of damaged forms of contractile and mitochondrial proteins in younger and older people.
Hypothesis 3: Resistance exercise will decrease the accumulation of damaged forms of contractile proteins in younger and older people.
Detailed description
The loss of muscle mass and function with age leads to high social and economic costs. Lifestyle interventions that can help maintain muscle mass and function can be beneficial to improve health and decrease the costs associated with loss of independence in the elderly. Muscle proteins accumulate damage during aging, which is suggested to lead to loss of function. The biological processes that remove damaged proteins and synthesis new proteins appear to be decreased with aging. Exercise is known to increase the processes that remove older and synthesis newer muscle proteins and may be an effect lifestyle intervention to improve muscle quality and function. Additionally, specific types of proteins appear to decay with age including contractile and mitochondrial proteins. Different types of exercise training can increase the making of specific proteins. The investigators will examine the ability for aerobic and resistance training to increase the quality of mitochondrial and contractile proteins between younger and older people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Training | Experimental | Behavioral: High intensity aerobic exerciseParticipants will perform 12-weeks of high intensity aerobic training. |
| Combined | Active comparator | Behavioral: CombinedThe combined group will have 12-weeks of no exercise followed by 12-weeks of combined aerobic and resistance exercise training. Assessments will be made at three time points: baseline, after 12-weeks of no training, and after 12-weeks of combined training. |
| Resistance Exercise Training | Experimental | Behavioral: Resistance exercise trainingParticipants will perform 12-weeks of resistance exercise training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- 18 to 30 years or 65 to 80 years old
- Male and female
Key exclusion criteria (8 listed)
- Regular exercise program
- Smoking
- Metabolic disease (diabetes, cardiovascular disease, cancer, thyroid disorders)
- Pregnancy
- Inability to exercise
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 |
|---|---|---|
| High intensity aerobic exerciseParticipants will perform 12-weeks of high intensity aerobic training. Training will be 5-days per week. Three days (e.g. Monday, Wednesday and Friday) will include repeated bouts of cycling for 4-minutes at ~90% maximal effort followed by 3 minutes of active rest. The other two days (e.g. Tuesday and Thursday) will be treadmill exercise for 45 minutes at 70% of maximal effort. | Behavioural | Aerobic Exercise Training |
| Resistance exercise trainingParticipants will perform 12-weeks of resistance exercise training. Training will be 5-days per week of daily sessions of 60 minutes that include resistance exercise for all major muscle groups. | Behavioural | Resistance Exercise Training |
| CombinedThe combined group will be assessed before and after 12 weeks of no exercise training, then again following 12 weeks of combined aerobic and resistance exercise training. | Behavioural | Combined |
Primary outcome
Skeletal muscle protein synthesis rate
Time frame: Approximately 14 weeks for the endurance or resistance training groups and approximately 28 weeks for the combined group
The investigators will determine the rate of incorporation of stable isotope amino acid tracers in skeletal muscle proteins during several hours of rest. The measurement will be an average resting muscle protein synthesis rate (% new muscle protein per hour) and will be performed at baseline and following 12 weeks of exercise training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Derived from this study: PubMed 40595512Pataky MW, Heppelmann CJ, Sevits KJ, Asokan AK, Kumar AP, Klaus KA, Dasari S, Kunz HE, Strub MD, Robinson MM, Coon JJ, Lanza IR, Adams CM, Nair KS. Aerobic and resistance exercise-regulated phosphoproteome and acetylproteome modifications in human skeletal muscle. Nat Commun. 2025 Jul 1;16(1):5700. doi: 10.1038/s41467-025-60049-0.
- Derived from this study: PubMed 36147777Zhang X, Habiballa L, Aversa Z, Ng YE, Sakamoto AE, Englund DA, Pearsall VM, White TA, Robinson MM, Rivas DA, Dasari S, Hruby AJ, Lagnado AB, Jachim SK, Granic A, Sayer AA, Jurk D, Lanza IR, Khosla S, Fielding RA, Nair KS, Schafer MJ, Passos JF, LeBrasseur NK. Characterization of cellular senescence in aging skeletal muscle. Nat Aging. 2022 Jul;2(7):601-615. doi: 10.1038/s43587-022-00250-8. Epub 2022 Jul 15.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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. This study is not recruiting at the moment.
K. Sreekumaran Nair, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity aerobic exercise, Resistance exercise training and Combined in people with Sarcopenia, run by Mayo Clinic 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 8 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle protein synthesis rate (time frame: Approximately 14 weeks for the endurance or resistance training groups and approximately 28 weeks for the combined group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477164, which also lists 2 linked publications.
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 8 Aug 2017.