Effects of Aerobic and Resistance Training on Accumulation of Old, Modified Proteins in Young and Older Adults

August 7, 2017 updated by: K. Sreekumaran Nair, Mayo Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • 18 to 30 years or 65 to 80 years old
  • Male and female

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Aerobic Exercise Training
Participants will perform 12-weeks of high intensity aerobic training.
Behavioral: High intensity aerobic exercise
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.
ACTIVE_COMPARATOR: Combined
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.
Behavioral: Combined
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.
EXPERIMENTAL: Resistance Exercise Training
Participants will perform 12-weeks of resistance exercise training.
Behavioral: Resistance exercise training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 14 weeks for the endurance or resistance training groups and approximately 28 weeks for the combined group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-005853

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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