NCT02098096

Brief Summary

The purpose of this study is to develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). "Negative work" is the force produced by muscles as they lengthen, and regularly occurs with common activities such as lowering an object from a shelf or walking down stairs. In this study, the investigators are examining the effectiveness of negative work exercise over a 12-week period in older, male, Veterans.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

3.6 years

First QC Date

March 19, 2014

Last Update Submit

September 18, 2018

Conditions

OsteoarthritisArthritis

Keywords

kneearthritisVeteransstrengthexercisemuscle

Outcome Measures

Primary Outcomes (2)

  • Maximum Voluntary Contraction (MVC; ft-lbs)

    Isokinetic assessment of MVC for the knee extensors and flexors.

    12 weeks

  • Muscle thickness (cm)

    Diagnostic ultrasound assessment of the rectus femoris

    12 weeks

Secondary Outcomes (4)

  • Step Up/Over Test (movement time (s); kinetics (force indices)

    12 weeks

  • Physical Performance Test (PPT-7)

    12 weeks

  • Knee injury and Osteoarthritis Outcome Score (KOOS; English version LK1.0)

    12 weeks

  • Visual Analog Scale for Pain (VAS; 0-10)

    12 weeks

Study Arms (2)

Negative Work

EXPERIMENTAL

Negative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks.

Other: Negative Work

Stretching

PLACEBO COMPARATOR

A home exercise program consisting of stretches for the major lower extremity muscles groups will be performed twice per week for 12 weeks.

Other: Stretching

Interventions

Negative WorkOTHER

Exercise will be performed twice per week for 12 weeks and exercise intensity will be progressed in three phases. These phases are: 1. Familiarization 2. Acclimatization 3. Progression Exercise volume will be 3 sets of 10 repetitions (progressing to 4 sets at Week 6) for the knee flexors and extensors. All exercise will be supervised by a physical therapist and performed on a Biodex isokinetic dynamometer.

Also known as: Eccentric exercise
Negative Work
StretchingOTHER

Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.

Stretching

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men 50 y.o. 70 years old will be recruited for this proposed study.
  • Gait aides and orthoses will not preclude participation in this study.

You may not qualify if:

  • In addition, major surgical procedures within the last six months, unstable joints, endocrine or metabolic disorders that result in excessive fatigue or muscle weakness, or use of medications that may impair exercise tolerance would also preclude participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington DC VA Medical Center

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

Location

Related Publications (2)

  • Harris-Love MO. Safety and efficacy of submaximal eccentric strength training for a subject with polymyositis. Arthritis Rheum. 2005 Jun 15;53(3):471-4. doi: 10.1002/art.21185. No abstract available.

    PMID: 15934111BACKGROUND

  • Hernandez HJ, McIntosh V, Leland A, Harris-Love MO. Progressive Resistance Exercise with Eccentric Loading for the Management of Knee Osteoarthritis. Front Med (Lausanne). 2015 Jul 9;2:45. doi: 10.3389/fmed.2015.00045. eCollection 2015.

    PMID: 26217665BACKGROUND

MeSH Terms

Conditions

OsteoarthritisArthritisMotor Activity

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Michael Harris-Love, DSc

    Washington DC VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 27, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2017

Study Completion

November 1, 2019

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

US(1)