NCT00844558

Brief Summary

Knee Osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The purpose of this research is to reduce disablement of older adults with symptomatic knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable knee-osteoarthritis

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

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
Last Updated

June 6, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

February 13, 2009

Results QC Date

July 2, 2015

Last Update Submit

May 2, 2016

Conditions

Knee Osteoarthritis

Keywords

osteoarthritisknee paingait trainingpower trainingrehabilitationphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument

    This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities. Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance).

    0,3,6, and 12 months

Secondary Outcomes (5)

  • Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain

    0,3,6 and 12 months

  • Change in KOOS Symptoms

    0,3,6 and 12 months

  • Change in Long Distance Corridor Walk (LDCW) Time, Secs

    0,3,6 and 12 months

  • Change in Stair Climb Time, Secs

    0,3,6, and 12 months

  • Change in Chair Stand Time

    0,3,6,and 12 months

Study Arms (2)

Gait Training

EXPERIMENTAL

Gait Training Intervention Group Participants

Other: Gait Training

Control

PLACEBO COMPARATOR

Gait Training Control Group Participants

Other: Control

Interventions

Gait TrainingOTHER

Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months

Gait Training
ControlOTHER

There is no intervention associated with this arm of the study

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 or older
  • Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)

You may not qualify if:

  • bilateral knee replacement
  • acute or terminal illness
  • unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring use of supplement oxygen, or current medical condition that affects walking, or lower limb musculoskeletal surgery in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Neil Segal
Organization
University of Iowa
segal-research@uiowa.edu
3193560737

Study Officials

  • Neil A Segal, MD, MS

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

August 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

June 6, 2016

Results First Posted

June 6, 2016

Record last verified: 2016-05

Locations

US(1)