NCT01355861

Brief Summary

The purpose of this study is to determine the benefits of negative work progressive resistance exercise (PRE) for the conservative management of sarcopenia in older male Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 14, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

March 14, 2011

Last Update Submit

June 25, 2015

Conditions

Keywords

sarcopeniaagingrehabilitationexercise

Outcome Measures

Primary Outcomes (1)

  • Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index)

    Blood tests will be obtained after a 12- hour overnight fast at baseline, weeks 6, week 12 and week 24: glucose and insulin values will be determined before and during a standard (75 g) 2 hour oral glucose tolerance test (to determine insulin sensitivity via QUICKI algorithm.

    Change from baseline in QUICKI values at week 6, week 12, and week 24

Secondary Outcomes (2)

  • Peak isokinetic torque

    Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12

  • Diagnostic ultrasongraphy

    Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12

Study Arms (2)

1

EXPERIMENTAL

Exercise group 1: Negative work exercise

Behavioral: Negative work exercise

2

OTHER

Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)

Behavioral: Negative work exercise

Interventions

Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks. Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.

Also known as: Biodex
12

Eligibility Criteria

Age60 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, DC

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

Cadaverine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biogenic PolyaminesBiogenic AminesAminesOrganic ChemicalsDiaminesPolyamines

Study Officials

  • Michael Harris-Love, DSc MPT BS

    VA Medical Center, DC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2011

First Posted

May 18, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations