NCT02350387

Brief Summary

The purpose of this study is to determine if there are differences in balance, strength, functional performance and self-reported outcomes for subjects with knee osteoarthritis who complete a low intensity, long duration eccentric training program compared to those who complete a high intensity, short duration eccentric training program. This study will be utilizing the Eccentron (manufactured by BTE Technologies) for the performance of all eccentric exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

January 20, 2015

Last Update Submit

February 25, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Isometric quadriceps strength as measured by a hand held dynamometer

    The primary outcome for this study is the change in quadriceps strength from baseline to 8 weeks (end of intervention) in both experimental groups.

    Change from baseline to 8 weeks

Secondary Outcomes (7)

  • Lower extremity muscle strength as measured by a hand held dynamometer

    Change from baseline to 8 weeks

  • Timed Up and Go Test

    Change from baseline to 8 weeks

  • 6-minute Walk Test

    Change from baseline to 8 weeks

  • Five times sit to stand test

    Change from baseline to 8 weeks

  • Balance (assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test)

    Change from baseline to 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

High Intensity Short Duration Exercise

EXPERIMENTAL

Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.

Procedure: High Intensity Short Duration Exercise

Low Intensity Long Duration Exercise

EXPERIMENTAL

Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.

Procedure: Low intensity Long Duration Exercise

Interventions

High Intensity Short Duration ExercisePROCEDURE

Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.

High Intensity Short Duration Exercise
Low intensity Long Duration ExercisePROCEDURE

Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.

Low Intensity Long Duration Exercise

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals will be included in the study if they are:
  • at least 55 years old,
  • cognitively able to understand directions,
  • able to ambulate at least 50 feet without stopping,
  • are currently experiencing knee pain and
  • meet at least 3 out of 6 criteria of the European League Against Rheumatism (EULAR) criteria for knee osteoarthritis diagnosis.

You may not qualify if:

  • Individuals will be excluded from the study if they have:
  • a diagnosed medical condition that would limit physical ability, including acute or active fractures, myocardial infarctions, stroke,
  • a traumatic brain injury within the last 6 months, or
  • joint replacement within the last 12 months. Individuals with chronic neurological disorders limiting motion or present with any known contraindication for balance training will also be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael J Bade, PT, PhD

    Regis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

US(1)