NCT01477164

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4.5 years

First QC Date

September 28, 2011

Last Update Submit

August 7, 2017

Conditions

Keywords

ExerciseAgingSarcopeniaMuscle function

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approximately 14 weeks for the endurance or resistance training groups and approximately 28 weeks for the combined group

Study Arms (3)

Aerobic Exercise Training

EXPERIMENTAL

Participants will perform 12-weeks of high intensity aerobic training.

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.

Behavioral: Combined

Resistance Exercise Training

EXPERIMENTAL

Participants will perform 12-weeks of resistance exercise training.

Behavioral: Resistance exercise training

Interventions

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.

Aerobic 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.

Resistance Exercise Training
CombinedBEHAVIORAL

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.

Combined

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • 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.

  • Zhang 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.

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • K. Sreekumaran Nair, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2011

First Posted

November 22, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2016

Study Completion

March 1, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations