NCT02638454

Brief Summary

Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt to anabolic stimulation may be a factor that contributes to sarcopenia. This project will provide novel insights into the role of microRNA in the attenuation of aging skeletal muscle to changes in gene expression after anabolic stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

December 17, 2015

Last Update Submit

July 16, 2025

Conditions

Keywords

ExerciseAnabolic ResistanceSkeletal MusclemicroRNA

Outcome Measures

Primary Outcomes (1)

  • Change of microRNA expression in humans skeletal muscle after an acute bout of high intensity resistance exercise

    Determine if the expression of miRNA in skeletal muscle after an acute bout of high-intensity resistance exercise in young, functionally-limited older adults with and without low muscle mass

    Baseline, immediately (within 15-30 min after acute resistance exercise) and 4 hours after acute resistance exercise

Study Arms (3)

HL-YNG

ACTIVE COMPARATOR

Healthy young sedentary males and females 20-30 yrs old Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise.

Procedure: Acute Resistance Exercise

FL-OLD

EXPERIMENTAL

Functionally-limited older sedentary males and females without sarcopenia (70-85 yrs old) Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise.

Procedure: Acute Resistance Exercise

SR-OLD

EXPERIMENTAL

Functionally-limited older sedentary males and females with clinically defined sarcopenia (70-85 yrs old) Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise.

Procedure: Acute Resistance Exercise

Interventions

1 bout of high-intensity resistance exercise at 80% of the individuals 1 repetition maximum

Also known as: Acute Strength Training
FL-OLDHL-YNGSR-OLD

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female
  • or 70-85 years of age
  • Sedentary: Must not participate in any regular exercise sessions (participants who walk regularly or walk for exercise are eligible)
  • Individuals must confirm good health
  • BMI must be between 19-35 kg/m2
  • Individuals must be fluent in English
  • Willing to come to the HNRCA laboratory for study visits
  • Short Physical Performance Battery of less than 9 (70-85 years of age cohort)
  • subjects with Normal Muscle Mass and 10 subjects with Low Muscle Mass as determined by DXA scan (70-85 years of age cohort) Low Muscle Mass is defined as Class I Sarcopenia, Skeletal Muscle Index within 1 to 2 standard deviations from the sex-specific mean of young adults

You may not qualify if:

  • Lost or gained 7.5% or more of their body weight in the past 6 months
  • Acute or terminal disease
  • Significant immune disorder
  • Types I and II Diabetes mellitus
  • Uncontrolled hypertension (\>180/100 mmHg)
  • Neuromuscular disease
  • Subjects must also not be participating in any regular endurance or resistance training exercise during the previous six months.
  • Mini-mental state examination (MMSE) score of \<23
  • Because of the DXA scan and the unknown risk associated with the muscle biopsy procedure, women who are pregnant, planning to become pregnant, or are breastfeeding will be excluded from the study.
  • Subjects with a history of any of the following within the past 6 months will be excluded:
  • Myocardial infarction in the past 6 months, or other symptomatic coronary artery disease.
  • Surgery in previous 6 months
  • Upper or lower extremity fracture in the previous 6 months
  • Allergy to lidocaine
  • Subjects currently taking any of the following drugs or classes of drugs will be excluded:
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Donato A Rivas, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist II

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 23, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations